Background:Adalimumab (ADA) is an effective treatment for moderate to severe hidradenitis suppurativa (HS). However, nearly half of patients receiving the standard dose may lose response. Objective:To establish therapeutic thresholds for HS-specific ADA levels, leading to more personalized treatment. Methods:We conducted a single-center, prospective observational study of adults with HS treated with ADA (40 or 80mg/week, and 80mg/biweekly) at a specialized HS clinic (January 2023-May 2024). Serum samples were collected after ≥4 weeks of therapy to ensure steady state. Patients were stratified by physician-assessed response (low <50%, partial 50-75%, high >75% improvement). Associations of ADA concentration and clearance with response were tested using Spearman and Pearson correlations; discriminatory performance was evaluated with ROC analysis. Results:Among 46 enrolled patients, the majority was female (60.9%) and White (54.3%), with a median age of 38 years (IQR: 30-45). ADA serum concentrations positively correlated with clinical response (r = 0.43, p = 0.002). Low responders had significantly lower concentrations than partial (p = 0.029) and high responders (p = 0.007). Clearance was inversely correlated with ADA levels (r = -0.65, p < 0.001). Receiver operating characteristic analysis identified optimal thresholds of 10.7 μg/mL for ADA concentration and 0.5 L/day for clearance. Conclusion:Higher ADA concentrations and lower drug clearance are associated with better clinical outcomes in HS. ROC analysis identified 10.7 μg/mL (ADA concentration) and 0.5 L/day (clearance) as optimal cut-off values to differentiate low from partial/high responders. These findings suggest that therapeutic drug monitoring may help optimize ADA therapy in HS.

International Journal of DermatologyEarly View Correspondence Treatment of necrobiosis lipoidica with secukinumab (Cosentyx): a case series Ruby S. Gibson MD, Ruby S. Gibson MD Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorPrerna Salian MPH, Prerna Salian MPH Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorAshley Beckles BS, Ashley Beckles BS Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorRobert Stavert MD, MBA, Robert Stavert MD, MBA Science 37, Durham, NC, USASearch for more papers by this authorSteven Tahan MD, Steven Tahan MD Harvard Medical School, Boston, MA, USA Division of Anatomic Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorAlexa B. Kimball MD, MPH, Alexa B. Kimball MD, MPH Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USA Harvard Medical School, Boston, MA, USASearch for more papers by this authorMartina L. Porter MD, Corresponding Author Martina L. Porter MD [email protected] Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USA Harvard Medical School, Boston, MA, USASearch for more papers by this author Ruby S. Gibson MD, Ruby S. Gibson MD Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorPrerna Salian MPH, Prerna Salian MPH Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorAshley Beckles BS, Ashley Beckles BS Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorRobert Stavert MD, MBA, Robert Stavert MD, MBA Science 37, Durham, NC, USASearch for more papers by this authorSteven Tahan MD, Steven Tahan MD Harvard Medical School, Boston, MA, USA Division of Anatomic Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USASearch for more papers by this authorAlexa B. Kimball MD, MPH, Alexa B. Kimball MD, MPH Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USA Harvard Medical School, Boston, MA, USASearch for more papers by this authorMartina L. Porter MD, Corresponding Author Martina L. Porter MD [email protected] Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, MA, USA Harvard Medical School, Boston, MA, USASearch for more papers by this author First published: 01 July 2023 https://doi.org/10.1111/ijd.16780 Conflict of interest: Dr. Kimball is a consultant and investigator for Abbvie, AnaptysBio, Bristol Meyers Squibb, ChemoCentryx, Janssen, Eli Lilly, Moonlake, Novartis, Pfizer, and UCB, Incyte; consultant for Regeneron, Alumis, Amgen, Priovant, Sanofi, Sonoma, Ventyx, and Bayer, receives fellowship funding from Janssen and Abbvie; and Board of Directors for Almirall. Dr. Porter is a consultant and/or investigator for Abbvie, Bristol Meyers Squibb, Janssen, Eli Lilly, Moonlake, Novartis, Pfizer, Trifecta Clinical (on behalf of acelyrin), UCB, Aristea, Regeneron, Innovoderm, Bayer, and Incyte. Dr. Gibson's fellowship was funded through the National Psoriasis Foundation. Dr. Gibson is an investigator for Abbvie, Janssen, Regeneron, Eli Lilly, Novartis, UCB, Aristea, Incyte, Innovoderm, Bayer, and Moonlake. Drs. Tahan and Stavert, Ms. Salian, and Ms. Beckles have no financial relationships or conflicts of interest relevant to this article to disclose. Funding source: The study was funded by Novartis, and medication was provided at no cost for this study. They approved the manuscript and the decision to submit for publication. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat Open Research Data availability statement The data that support the findings of this study are available from the corresponding author, MP, upon reasonable request. References 1Wakusawa C, Fujimura T, Kambayashi Y, Furudate S, Hashimoto A, Aiba S. Pigmented necrobiosis lipoidica accompanied by insulin-dependent diabetes mellitus induces CD163+ proinflammatory macrophages and interleukin-17-producing cells. Acta Derm Venereol. 2013; 93(4): 475–6. https://doi.org/10.2340/00015555-1502 2Foss C, Clark A, Inabinet R, Camacho F, Jorizzo J. An open-label pilot study of alefacept for the treatment of pyoderma gangrenosum. J Eur Acad Dermatol Venereol. 2008; 22(8): 943–9. https://doi.org/10.1111/J.1468-3083.2008.02680.X 3Wilson D, Hockenberry MJ, Wong DL. Wong's clinical manual of pediatric nursing. 7th ed. St. Louis, Mo: Mosby Elsevier; 2008. 4Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994; 19(3): 210–6. https://doi.org/10.1111/J.1365-2230.1994.TB01167.X 5Gottlieb AB, Wu JJ, Griffiths CEM, Marfo K, Muscianisi E, Meng X, et al. Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials. J Dermatol Treat. 2020; 33(3): 1482–90. https://doi.org/10.1080/09546634.2020.1832187 Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation

Background: A prior study of Medicare beneficiaries in 2011 suggested black patients are less likely to be prescribed biologics than white patients. An investigation from Beth Israel Deaconess Medical Center conducted between Jan 2010-Dec 2021 did not find a difference in the prescription rates of systemic medications between black and white patients. This study sought to investigate if these racial disparities were present when looking at data from 2000-2009 or when comparing types of insurance.

BACKGROUND:Hidradenitis suppurativa (HS) fistulas are likely to persist without surgical intervention. Hypertonic saline (HTS), a venous sclerosant, disrupts the endothelial lining leading to occlusion and fibrosis when used for venous insufficiency. OBJECTIVE:To evaluate the efficacy and tolerability of HTS sclerotherapy for HS fistulas. METHODS AND MATERIALS:This Institutional review board-approved, nonrandomized, clinical trial included adult patients with a diagnosis of HS and at least one confirmed HS fistula who underwent HTS injections into their fistulas every two weeks followed by a 4-week follow-up period. The study was performed from 2016 to 2019 at two academic outpatient dermatology clinics in Boston, MA. Primary outcomes were physician-assessed improvement of HS fistula characteristics between final and baseline visits and physician-assessed HS improvement during course of study. RESULTS:Overall, 21 patients participated. Physician-assessed overall HS improvement was significant between Visits 2 and 3 (p = .036). Drainage (p = .035), erythema (p = .008), and swelling (p = .025) demonstrated statistically significant improvement from baseline to final visit. Dermatology life quality index scores significantly improved from baseline to Visit 2 (p = .0005), Visit 3 (p = .0008), and final visit (p = .011). Numeric rating scale stinging scores increased with sclerosant volume. CONCLUSION:This study demonstrated physician-reported and patient-reported improvement in fistulas following serial HTS injections. HTS injections were well tolerated.

What is known about this subject in regard to women and their families? Hidradenitis suppurativa is a chronic, debilitating inflammatory skin condition predominantly affecting women. Few studies have characterized laboratory abnormalities in patients with severe hidradenitis suppurativa. Laboratory abnormalities in patients with severe hidradenitis suppurativa can prompt unnecessary medical resource utilization due to concern for malignancy or infection. What is new from this article as messages for women and their families? Patients with severe hidradenitis suppurativa can have laboratory abnormalities related to the systemic inflammatory nature of their disease. Initiation of immunomodulatory therapy can normalize these laboratory abnormalities and improve physician- and patient-reported disease severity over time. Knowledge that laboratory abnormalities can be seen in severe hidradenitis suppurativa patients can prevent unnecessary workup for infection or malignancy. Dear Editors, Hidradenitis suppurativa (HS) is an inflammatory skin condition predominantly affecting females in North America that has been found to be associated with anemia and leukocytosis.1–3 While thrombocytosis is not recognized as related to HS, it would be expected in a systemic inflammatory state.4 Laboratory abnormalities in severe HS patients can prompt unnecessary medical utilization due to concern for malignancy or infection, and we have observed patients undergo bone marrow biopsy unnecessarily. Better characterization of laboratory values can prevent unwarranted concern. We performed an Institutional Review Board-approved retrospective review of HS patients visiting an academic institution in Boston, MA, from 2015 to 2020. Leukocytosis (white blood cell [WBC] > 10 × 109/L), thrombocytosis (platelet > 400 × 109/L), and anemia (men: hemoglobin [Hb] < 13.0 g/dL, women: Hb < 12.0 g/dL) were considered abnormal. Medications were extrapolated from the joint National Psoriasis Foundation-American Academy of Dermatology guidelines.5 Laboratory values were tracked in 3–6-month periods from medication initiation, and patients were consistently on these medications throughout follow-up (Fig. 1). Laboratory values were analyzed for significant changes from therapy initiation. The means ± standard deviations at baseline and follow-up and the mean of individual-level differences were presented. Wilcoxon signed-rank tests were used to determine whether differences between baseline and follow-up laboratory values differed significantly from zero. Tests were 2-sided with nominal significance level of 5%.Fig. 1.: Laboratory abnormalities over time with immunomodulatory therapy. Colored trend lines represent the laboratory values of individual patients. Black lines represent the mean laboratory value for all patients with data in a given time period. RBC, red blood cell; WBC, white blood cell.We identified thirty patients on immunomodulatory therapy, including methotrexate, adalimumab, infliximab, risankizumab, tofacitinib, or ustekinumab. Seventy-seven percent of patients were female, while 50% were White, 20% Black, 7% Asian, 13% mixed race, and 10% unspecified. Five had coexisting autoimmune disease (Crohn's disease n = 3, Celiac disease n = 1, atopic dermatitis n = 1). One patient had Hurley I HS, 7 Hurley II, 21 Hurley III, and 1 Hurley II/III. Eighty-three percent of patients (n = 25) were on concomitant antibiotics at any point during the study, but patients were on antibiotics for only 13% of all patient days. Eight patients were treated for active infections during the study, and 2 had infections at baseline, 1 with impetigo and 1 with cellulitis. Twenty-four patients had baseline leukocytosis, which decreased significantly from baseline at 90–120 days (P = 0.005) and remained significantly lower than baseline at 181–245 (P = 0.012) and 300–365 (P = 0.018) days (Table 1; Supplementary Table 1, https://links.lww.com/IJWD/A2). The median follow-up WBC count remained lower than the median baseline WBC count beyond 2 years. WBC levels normalized by 300–365 days. While the 2 patients with infections at baseline were included in the leukocytosis group, they experienced continued decline of WBC levels 6 and 10 months after completing infection treatment. Table 1. - Difference in white blood cell, platelet, and hemoglobin levels among patients with abnormal baseline values Abnormal baseline white blood cell counts Time since baseline Baseline (× 109/L) Follow-up (× 109/L) Difference (× 109/L) P Days 90–120 (n = 11) 13.4 (12.0–19.5) 10.8 (9.9–13.8) –2.6 0.0051 Days 121–180 (n = 12) 12.4 (11.4–14.1) 11.5 (8.9–13.3) –0.9 0.13 Days 181–245 (n = 10) 13.2 (11.5–15.0) 10.4 (9.7–11.6) –2.8 0.012 Days 245–300 (n = 9) 13.4 (10.7–15.0) 10.1 (9.5–11.7) –3.3 0.11 Days 300–365 (n = 7) 12.0 (11.2–13.4) 8.7 (7.4–9.5) –3.3 0.018 Days 365–752 (n = 4) 12.5 (11.4–13.5) 8.6 (7.5–10.0) –3.9 0.068 Abnormal baseline platelet counts Time since baseline Baseline (× 109/L) Follow-up (× 109/L) Difference (× 109/L) P Days 90–120 (n = 9) 508 (431–556) 456 (369–491) –52 0.17 Days 121–180 (n = 10) 499 (431–527) 448 (389–491) –51 0.11 Days 181–245 (n = 7) 511 (419–581) 379 (336–513) –132 0.13 Days 245–300 (n = 8) 501 (433–554) 373 (323–480) –128 0.036 Days 300–365 (n = 5) 447 (431–490) 401 (318–401) –46 0.043 Days 365–752 (n = 3) 581 (417–613) 391 (302–470) –190 0.11 Abnormal baseline hemoglobin—women Time since baseline Baseline (g/dL) Follow-up (g/dL) Difference (g/dL) P Days 90–120 (n = 1) 10.4 11.1 +0.7 — Days 121–180 (n = 5) 10.4 (9.3–11.1) 11.1 (10.5–11.9) +0.7 0.35 Days 181–245 (n = 5) 10.7 (10.4–11.0) 12.0 (10.1–12.2) +1.3 0.35 Days 245–300 (n = 5) 10.7 (10.4–11.0) 10.9 (10.0–12.2) +0.2 0.69 Days 300–365 (n = 2) 11.3 (11.0–11.5) 13.0 (11.5–14.5) +1.7 0.18 Days 365–752 (n = 0) — — — — Abnormal baseline hemoglobin—men Time since baseline Baseline (g/dL) Follow-up (g/dL) Difference (g/dL) P Days 90–120 (n = 5) 10.4 (9.4–12.1) 11.5 (9.8–11.8) +1.1 0.35 Days 121–180 (n = 3) 12.1 (8.3–12.2) 11.9 (9.0–12.2) –0.2 0.59 Days 181–245 (n = 2) 10.2 (8.3–12.1) 11.8 (11.0–12.5) +1.6 0.18 Days 245–300 (n = 2) 10.2 (8.3–12.1) 12.9 (12.3–13.4) +2.7 0.18 Days 300–365 (n = 0) — — — — Days 365–752 (n = 1) 8.3 16.2 +7.9 — Data are shown as median values (with interquartile range also reported). Differences with significant P values (≤0.05) are indicated in bold font. "—" refers to a range of numbers. "–" is a minus sign. Fifteen patients had baseline thrombocytosis (Supplementary Table 1, https://links.lww.com/IJWD/A2). Platelet counts decreased over time, and this difference was significant at 245–300 (P = 0.036) and 300–365 (P = 0.043) days (Table 1). Platelet counts returned to normal by 365–752 days. Patients (n = 14) with baseline anemia showed nonsignificant improvement in Hb (Table 1; Supplementary Table 1, https://links.lww.com/IJWD/A2). Most patients (57.1%) had resolution of anemia at follow-up (median: 245 days). One patient was treated for anemia during follow-up with ferrous sulfate. Sixteen of 26 patients (62%) with patient-recorded disease status reported improvement compared with baseline at last laboratory follow-up, while 17 of 25 (68%) had physician-reported improvement. We observed that immunomodulatory therapy was associated with significant declines in leukocytosis and thrombocytosis with normalization by 300–365 days. This raises awareness that laboratory abnormalities in severe HS patients can reflect underlying disease rather than infection or malignancy. Conflicts of interest The authors made the following disclosures: A.B.K.: Consultant and investigator for AbbVie, Bristol Meyers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; consultant for Kymera, Almirall, investigator ChemoCentryx; receives fellowship funding from Janssen and Abbvie; and served as previous Board Of Directors and Past President of the International Psoriasis Council and Board Of Directors of the HS Foundation. M.L.P.: Consultant and investigator for UCB, Pfizer, Eli Lilly, and Novartis and an investigator for Abbvie, Janssen, and Bristol Meyers Squibb. P.C.M.-W., C.G., Z.E.H., T.Y., P.S., and D.K.: None. Funding None. Study approval The author(s) confirm that any aspect of the work covered in this manuscript that has involved human patients has been conducted with the ethical approval of all relevant bodies. Patient consent Informed, written consent was received from all patients and confirmed to the journal prepublication, stating that the patients gave consent for their photos and case history to be published. Supplementary materials Supplementary material associated with this article can be found at https://links.lww.com/IJWD/A2.

What is known about this subject in regard to women and their families? Hidradenitis suppurativa (HS) disproportionately affects females in the United States. HS is a disease that can result in debilitating pain and reduced quality of life. The majority of women with HS experience a worsening of symptoms during pregnancy. High rates of postpartum flares have also been reported. Therefore, HS care is essential during the perinatal and postpartum periods. What is new from this article as messages for women and their families? This study demonstrates a dearth of HS specialty clinics in the United States that results in greater travel burdens for patients of lower socioeconomic status. As HS is a progressive disease that requires routine care, women who find the travel burden prohibitive may face worsened disease progression. Dear Editors, The prevalence of hidradenitis suppurativa (HS) is estimated to be 0.00033 to 4.1% with 33 HS specialty clinics in the United States1,2 (Supplementary Fig. 1, https://links.lww.com/IJWD/A14) The low number of HS specialty clinics presents a challenge for patients seeking subspecialty care, and long travel distances may also exacerbate healthcare disparities. Our study demonstrates a significant travel burden on HS patients compared to patients with psoriasis, which has a similar prevalence but over 1,000 specialists nationwide.3,4 Patients seen in the Department of Dermatology at Beth Israel Deaconess Medical Center from 2016 to 2019 with either a diagnosis of (1) HS or (2) psoriasis with previous documentation of phototherapy or systemic therapy were included. Socioeconomic status (SES) was measured by insurance, percent of individuals living under the poverty line at the patients’ zip codes of residence, and percent of households participating in the Supplemental Nutrition Assistance Program (SNAP) at the patients’ zip codes of residence. Information for the latter two measures were acquired from the 2019 American Community Surveys.5 Distance between patients’ addresses and BIDMC was calculated using Google Maps. Analysis was performed using SPSS v.27.0.1.0 (Kruskal-Wallis test, P < .001 for statistical significance). Of 313 HS patients, 81.5% were female, 21.4% were on Medicaid, and 66.5% were White, with a median age of 37 (IQR: 29-49) years (Table 1). Of 187 psoriasis patients, 47.6% were female, 7% were on Medicaid, and 71.7% were White, with a median age of 55 (IQR: 43-65) years (Table 1). HS patients traveled a median distance of 21.0 versus 9.9 miles for psoriasis patients (P < .001). The range of distance traveled was greater in the HS group (1307.6 vs 210.7 miles), and 11.2% of HS patients traveled more than 100 miles to access care versus 0.05% of psoriasis patients (Table 1). Table 1 - Demographic characteristics of HS and psoriasis patients seen at BIDMC5 HS count (%) Psoriasis count (%) P Sex Male 58 (18.5%) 98 (52.4%) <.001** Female 255 (81.5%) 89 (47.6%) Age, years Median (IQR, range) 37 (29-49, 62) 55 (43-65, 65) <.001** SES, insurance Medicaid 67 (21.4%) 13 (7.0%) <.001** Non-Medicaid 246 (78.6%) 174 (93.0%) SES, % individuals living under poverty line <5% 72 (23.2%) 44 (23.7%) 0.393 5-20% 198 (63.7%) 125 (67.2%) >20% 41 (13.2%) 17 (9.1%) SES, % households receiving SNAP <5% 70 (22.5%) 59 (31.7%) 0.030 5-20% 181 (58.2%) 86 (46.2%) >20% 60 (19.3%) 41 (22.0%) Race Asian 9 (2.9%) 23 (12.3%) <.001** Black 66 (21.1%) 18 (9.6%) Hispanic 21 (6.7%) 9 (4.8%) Other 9 (2.9%) 3 (1.6%) White 208 (66.5%) 134 (71.7%) Language English 307 (98.1%) 163 (87.2%) <.001** Non-English 6 (1.9%) 24 (12.8%) Hurley 1 101 (32.3%) – – 2 138 (44.1%) – – 3 74 (23.6%) – – Miles from BIDMC Median (IQR, range) 21.0 (5.7-52.7, 1307.6) 9.9 (4.8-24.2, 210.7) <.001** Miles from BIDMC, binned by Distance ≤20.0 154 (49.2%) 132 (70.6%) <.001** 20.1-100.0 124 (39.6%) 54 (28.9%) >100.0 35 (11.2%) 1 (0.05%) BIDMC, Beth Israel Deaconess Medical Center; HS, hidradenitis suppurativa; IQR, interquartile range; SES, socioeconomic status; SNAP, Supplemental Nutrition Assistance Program.**Statistical significance (P < .001). Subgroup analysis of HS patients indicates that higher SES patients traveled further distances by all measures of SES: (1) Insurance: 8.9 (Medicaid) versus 28.9 (non-Medicaid) miles; (2) percent of individuals living under poverty line: 29.6 (<5%) versus 22.4 (5-20%) versus 3.7 (>20%) miles; and (3) percent of households receiving SNAP: 26.6 (<5%) versus 25.1 (5-20%) versus 5.8 (>20%) miles; all P < .001 (Table 2, Supplementary Fig. 2, https://links.lww.com/IJWD/A15). Table 2 - Distances traveled by HS and psoriasis patients to BIDMC5 HS (n = 313) Psoriasis (n = 187) Count (%) Median (IQR) P Count (%) Median (IQR) P Sex Male 58 (18.5%) 21.4 (6.9-58.3) 0.626 98 (52.4%) 9.2 (4.3-22.0) 0.128 Female 255 (81.5) 20.9 (5.3-52.3) 89 (47.6%) 11.8 (5.7-26.5) Age, years <30 97 (31.0%) 22.3 (6.2-57.5) 0.037 15 (8.0%) 15.2 (7.3-30.0) 0.564 31-50 145 (46.3%) 12.8 (5.0-45.2) 57 (30.5%) 8.8 (5.3-23.7) >51 71 (22.7%) 34.8 (9.8-56.8) 115 (61.5%) 10.1 (4.2-25.7) SES, Insurance Medicaid 67 (21.4%) 8.9 (4.0-22.5) <.001** 13 (7.0%) 8.7 (4.1-11.0) 0.5 Non-Medicaid 246 (78.6%) 28.9 (6.5-56.8) 174 (93.0%) 9.9 (4.8-24.8) SES, % individuals living under poverty line <5% 72 (23.2%) 29.6 (14.2-51.2) <.001** 44 (23.7%) 18.8 (11.5-25.5) <.001** 5-20% 198 (63.7%) 22.4 (6.0-56.2) 125 (67.2%) 9.6 (5.3-25.7) >20% 41 (13.2%) 3.7 (2.5-5.6) 17 (9.1%) 2.5 (1.9-3.2) SES, % households receiving SNAP <5% 70 (22.5%) 26.6 (6.6-47.3) <.001** 59 (31.7%) 16.2 (7.3-25.2) 0.2 5-20% 181 (58.2%) 25.1 (7.4-56.8) 86 (46.2%) 9.7 (4.1-18.0) >20% 60 (19.3%) 5.8 (3.6-31.4) 41 (22.0%) 7.7 (4.2-26.5) Race White 208 (66.5%) 35.8 (10.0-57.9) <.001** 134 (71.7%) 10.25 (5.4-26.5) 0.2 Non-White 105 (33.5%) 6.2 (3.7-21.8) 53 (28.3%) 8.1 (3.7-17.1) Language English 307 (98.1%) 21.7 (5.7-53.3) 0.222 163 (87.2%) 10.0 (5.3-24.8) 0.137 Non-English 6 (1.9%) 7.9 (4.8-22.5) 24 (12.8%) 6.6 (3.0-15.0) Hurley 1 101 (32.3%) 8.9 (4.1-38.7) <.001** – – – 2 138 (44.1%) 22.7 (7.1-50.8) – – 3 74 (23.6%) 37.4 (7.3-74.1) – – BIDMC, Beth Israel Deaconess Medical Center; HS, hidradenitis suppurativa; IQR, interquartile range; SES, socioeconomic status; SNAP, Supplemental Nutrition Assistance Program.**Statistical significance (P < .001). Limitations for this study include being a single-center study and comparing HS patients of all disease stages to psoriasis patients with moderate-to-severe disease. ACS information is the representative of US zip codes. HS patients were found to travel more than twice the distance of psoriasis patients to obtain access to specialized care. Higher SES patients travel further than lower SES patients, who may be unable to afford to travel long distances for care. As HS requires routine follow-ups to prevent disease progression, steps must be taken to expand the reach of HS care, especially to lower SES patients. Providing HS-specific training to providers, increasing the use of telemedicine, and providing transport options can reduce disparities in HS severity and protect at-risk populations from disease progression. Conflicts of interest M.P. is a consultant and an investigator for UCB, Pfizer, Eli Lilly, and Novartis and an investigator for Abbvie, Janssen, and Bristol Meyers Squibb. A.B.K. is a consultant and Investigator for Abbvie, Bristol Meyers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; a consultant for Kymera, Amirall, Investigator ChemoCentryx; receives fellowship funding from Janssen and Abbvie; and served as previous Board of Directors and Past President of the International Psoriasis Council and Board of Directors of the HS Foundation. D.K., N.G., and P.S. do not have any conflicts of interest to disclose. Funding None Study approval Informed, written consent was received from all patients and confirmed to the journal pre-publication, stating that the patients gave consent for their photos and case history to be published. Reviewed and approved by Beth Israel Deaconess Medical Center Committee on Clinical Investigations (CCI/IRB).

To the Editor: Guidelines have been published regarding the management of cutaneous malignancy since the start of the COVID-19 pandemic.1Tagliaferri L. Di Stefani A. Schinzari G. et al.Skin cancer triage and management during COVID-19 pandemic.J Eur Acad Dermatol Venereol. 2020; 34: 1136-1139Crossref PubMed Scopus (35) Google Scholar,2Baumann B.C. MacArthur K.M. Brewer J.D. et al.Management of primary skin cancer during a pandemic: multidisciplinary recommendations.Cancer. 2020; 126: 3900-3906Crossref PubMed Scopus (56) Google Scholar In addition, a recent report was published regarding a change in the volume of tumors treated in one dermatologic surgery unit due to the pandemic.3Tee M.W. Stewart C. Aliessa S. et al.Dermatological surgery during the COVID-19 pandemic: experience of a large academic center.J Am Acad Dermatol. 2020; Google Scholar However, no studies have further evaluated the impact of COVID-19 on the treatment of cutaneous malignancies by dermatologic surgeons. We studied the changes in demographics and surgical practices during the COVID-19 pandemic in one dermatologic surgery unit, where patients were prioritized based on the presence of high-risk features of cutaneous malignancies.4National Comprehensive Cancer Network guidelines and clinical resources.https://www.nccn.org/professionals/physician_gls/Date accessed: December 29, 2020Google Scholar We included patients seen in our dermatologic surgery unit for either Mohs surgery or excisions between April 28, 2020 and July 31, 2020 (offices were closed for 6 weeks prior to this time) and an equally sized, randomly selected comparator group of patients seen during the same months in 2019. We excluded patients whose procedures were converted to nonsurgical visits, patients who underwent diagnostic procedures, and patients with no previous biopsies. We extracted demographic information and tumor type for each patient. We collected information on the size of the final Mohs defect and the number of stages for Mohs surgery patients. We collected the final linear repair size for excisional surgery patients. Separate procedures on the same patient were analyzed separately. A Kruskal-Wallis test was used to compare the different groups by year. P values < .05 were considered statistically significant. The total number of Mohs surgeries or excisions performed within the same months in 2019 was 1045 versus 418 in 2020. There were no statistically significant differences between the prepandemic and pandemic era in terms of demographic factors or type of procedure (Mohs surgery vs excision). Similarly, the average size of the final defect and the average number of stages were similar between the 2 groups for patients undergoing Mohs surgery. The average size of the linear repair was also similar for patients undergoing excisional surgery. However, there was a statistically significant difference in the type of neoplasms treated. During the pandemic, there was an increase in the squamous cell carcinomas treated, a decrease in the basal cell carcinomas treated, and a decrease in the invasive melanomas treated (P = .006; Table I).Table IDemographic and surgical characteristics of dermatologic surgery patients in the pre-pandemic era versus pandemic era20192020P valueType of procedure, n.07 Mohs surgery283259 Excisional surgery119143Mean age at time of procedure (SD), y68 (14.9)67 (14.4).35Number of non-english speaking patients, n10 (1 Albanian, 1 ASL, 1 Cape Verdean, 1 Mandarin, 1 Portuguese, 3 Russian, 1 Spanish, 1 Vietnamese)8 (1 Albanian, 6 Russian, 1 Spanish).63Highest level of education, n.54 8th grade or less40 Some high school34 Graduated from high school or obtained my General Educational Development Test6045 Some college/vocational/technical program5060 Graduate from college, graduate, or postgraduate school247255 Unknown3838Type of tumor, n.006 BCC193155 SCC160185 Invasive melanoma96 MMIS87 Dysplastic nevus2843 Other (AFX, PDS, pyogenic granuloma, EMPD, MAC, porocarcinoma)46Average size of Mohs defect, cm23.213.31.77Average number of Mohs stages1.71.6.47Average size of linear excisions, cm5.05.4.05AFX, Atypical fibroxanthoma; BCC, basal cell carcinoma; EMPD, extramammary Paget's disease; MAC, microcystic adnexal carcinoma; MMIS, malignant melanoma in situ; PDS, pleomorphic dermal sarcoma; SCC, squamous cell carcinoma, SD, standard deviation. Open table in a new tab AFX, Atypical fibroxanthoma; BCC, basal cell carcinoma; EMPD, extramammary Paget's disease; MAC, microcystic adnexal carcinoma; MMIS, malignant melanoma in situ; PDS, pleomorphic dermal sarcoma; SCC, squamous cell carcinoma, SD, standard deviation. We prioritized surgery for cutaneous lesions with high-risk features upon reopening, including squamous cell carcinomas over basal cell carcinomas, given the higher likelihood for metastasis.4National Comprehensive Cancer Network guidelines and clinical resources.https://www.nccn.org/professionals/physician_gls/Date accessed: December 29, 2020Google Scholar Despite this, however, the treatment of patients during the pandemic resulted in similar final Mohs defect sizes, number of Mohs stages, and linear repair sizes. Our findings stand in contrast to a study that assessed non-melanoma skin cancer in a plastic surgery clinic, which found that the tumors removed in 2020 were larger compared to prior years.5Capitelli-McMahon H. Hurley A. Pinder R. Matteucci P. Totty J. Characterising non-melanoma skin cancer undergoing surgical management during the COVID-19 pandemic.J Plast Reconstr Aesthet Surg. 2021; 74: 644-710Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar This difference may be due to the differences in triage or surgical factors given the lack of skin-conserving modalities, such as Mohs surgery. Study limitations include a small sample size from a single academic institution. Nonetheless, our findings demonstrate that the triage in our dermatologic surgery unit during the COVID-19 pandemic resulted in a different mix of tumor types but did not impact the demographic breakdown of patients or surgical complexity of cases. Further work is needed to understand the long-term impact of triage during the COVID-19 pandemic on dermatologic surgery outcomes. The authors declare no relevant conflicts of interest.

To the Editor: The standard treatment for squamous cell carcinomas (SCCs) is wide local excision or Mohs micrographic surgery. Excision of SCCs in difficult areas, such as the lower extremity, can be challenging and associated with increased complications.1 Intralesional 5-fluorouracil (IL5-FU) is a minimally invasive therapeutic option that may benefit select patients for whom surgical excision is not desired or feasible. Most studies to date have been limited to small studies, case series, and recent case reports.

BackgroundPatients with skin of color are at risk for skin cancer, pigmentary disorders, and photo-exacerbated conditions but find it challenging to use sunscreens on the market that leave an obvious residue on their skin.ObjectiveThe objective of this study was to examine sunscreen recommendations from the popular press and from practicing dermatologists for patients with skin of color.MethodsWe queried the Google search engine with the following search terms: “Sunscreen” with “skin of color,” “dark skin,” “black skin.” For comparison, we also searched for “sunscreen” with “white skin,” “pale skin,” and “fair skin.” We conducted an anonymous survey regarding sunscreen recommendations among dermatology trainees and board-certified dermatologists.ResultsWebsites with recommendations on sunscreens for patients with skin of color compared with sunscreens for white or fair skin were more likely to recommend chemical sunscreens (70% vs. 36%) and more expensive products (median: $14 vs. $11.3 per ounce), despite the lower sun protection factor level (median: 32.5 vs. 50). In our survey study, dermatologists were overall cost-conscious and felt that sun protection factor level, broad spectrum (ultraviolet A/B protection), and price were the most important features of sunscreens for their patients. Cosmetic elegance was deemed least important. Dermatologists overall counseled patients with skin of color less on sunscreen use, and 42.9% reported that they either never, rarely, or only sometimes take patients’ skin type into account when making sunscreen recommendations.ConclusionThese data represent an area for growth within dermatology to improve culturally competent care by gaining familiarity with sunscreen types and formulations that are geared toward patients with skin of color.

BACKGROUND:Methotrexate is an immunomodulatory therapy that may offer benefit to patients with hidradenitis suppurativa (HS). Despite its theoretical advantages, there is a paucity of available data regarding long-term methotrexate use in patients with HS.OBJECTIVE:This study aimed to assess whether methotrexate treatment leads to improvement in HS disease severity.METHODS:We conducted an institutional review board-approved, single-center, retrospective chart review of patients with HS who were treated with methotrexate between 2000 and 2018. Primary outcome measurements included the HS Physician's Global Assessment (HS PGA), Hurley staging, abscess count, fistula count, and inflammatory nodule count.RESULTS:A total of 29 patients were identified; 14 were excluded for reasons including never starting methotrexate and missing follow-up data. For remaining patients (n = 15), the average cumulative dose of methotrexate was 520.1 mg (range, 30-1665 mg) and the average length of treatment was 11.7 months (range, 1-38 months). Patients taking methotrexate as a primary therapy had a higher cumulative dose and length of treatment (520.13 mg; 14.6 months) compared with those taking biologics concomitantly (468.44 mg; 9.1 months). Patients using methotrexate as primary therapy demonstrated nonsignificant reductions in HS PGA, inflammatory nodule count, and abscess count. Patients on concomitant biologic therapy failed to demonstrate any change in HS PGA, inflammatory nodule count, and abscess count.LIMITATIONS:Limitations of the study include its retrospective nature, small sample size, length of time on methotrexate between groups, and homogeneity of the patient population.CONCLUSION:Methotrexate may represent an effective treatment option in older patients with lower body mass indices but fails to offer benefit in patients taking concurrent biologic therapy.

To the Editor: As the coronavirus disease 2019 (COVID-19) pandemic has rapidly spread around the globe, concern has been raised regarding susceptibility of patients receiving immunomodulatory therapies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Although general guidance has been put forth, data regarding infection rate and outcomes in immunosuppressed patients are still rare.1Lebwohl M. Rivera-Oyola R. Murrell D.F. Should biologics for psoriasis be interrupted in the era of COVID-19?.J Am Acad Dermatol. 2020; 82: 1217-1218Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar Recent articles, including the work by Gisondi et al,2Gisondi P. Zaza G. Del Giglio M. Rossi M. Iacono V. Girolomoni G. Risk of hospitalization and death from COVID-19 infection in patients with chronic plaque psoriasis receiving a biological treatment and renal transplanted recipients in maintenance immunosuppressive treatment.J Am Acad Dermatol. 2020; 83: 285-287Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar suggest that outcomes of patients receiving systemic immunomodulatory therapies who are infected with SARS-CoV-2 are similar to those of the general population. These findings may relate to the aberrant cytokine and inflammatory responses in severe COVID-19, which may be treated or partially blunted by cytokine-targeted therapy.3Shi Y. Wang Y. Shao C. et al.COVID-19 infection: the perspectives on immune responses.Cell Death Differ. 2020; 27: 1451-1454Crossref PubMed Scopus (1076) Google Scholar Given the substantial outbreak of COVID-19 in our community, we tested whether, in addition to similar outcomes, patients receiving systemic immunomodulatory therapy had infection rates similar to those of the general population. We performed a retrospective cross-sectional analysis of patients treated across all providers at Beth Israel Deaconess Department of Dermatology. Our clinical practice has 412 patients receiving systemic immunomodulatory medications, including biologics and traditional immunosuppressives, prescribed within the past year. Patients were surveyed by a clinic telephone call, by a telemedicine visit, or through an outreach wellness check-in call from March 15 to May 8, 2020, corresponding to the peak incidence of new cases of COVID-19 in Massachusetts. Of our 412 patients, 327 were successfully contacted, with approximately 80% contacted after April 19, 2020. We were not able to identify any hospitalizations in Boston-area hospitals for the other 85 patients. Results are shown in Table I, with age distributions and conditions requiring immunomodulatory therapy displayed in Fig 1. There were no statistical differences in age, sex, or medications between the patients who were reached and those who were not.Table IBaseline characteristics of patients receiving immunosuppressive therapyCharacteristicAll patients (n = 412)Patients with positive and presumed-positive results (n = 5)Demographics Mean age (SD), y48.2 (15.9)48.4 Men, No. (%)196 (48)2 (40) Women, No. (%)216 (52)3 (60) Live in Massachusetts, No. (%)382 (93)5 (100)Medications, No. (%) Biologics TNFα inhibitor117 (28.4)2 (40) IL-17 inhibitor29 (7)0 IL-23 inhibitor30 (7.3)0 IL-12/23 inhibitor54 (13.2)1 (20) JAK inhibitor12 (2.9)0Traditional immunosuppressives No. (%) Methotrexate48 (11.7)1 (20) Cyclosporine5 (1.2)0 Mycophenolate mofetil8 (1.9)0Other immunomodulatory therapies, No. (%) IL-4Rα inhibitor65 (15.8)0 Apremilast26 (6.3)1 (20) Multiple medications (combination of multiple biologics, traditional immunosuppressives, and other immunomodulatory therapies)18 (4.4)0COVID-19 outcomes, No. (%) COVID-related hospitalization1 (0.2)1 (20) Any cause of death00Degree of contact with others, No. (%)n = 260n = 5 None (patient generally not leaving home)158 (60.8)1 (33) Patient with minimal degree of contact at work31 (11.9)0 Patient with minimal degree of contact at home31 (11.9)1 (33) Patient with minimal degree of contact both at work and home9 (3.5)0 Patient with high degree of contact at work and home22 (8.5)1 (33) Household member with high degree of contact at work9 (3.5)0COVID-19 symptoms/testing, No. (%)Patients self-reporting symptoms (n = 25)∗Symptoms include any patient-reported symptom of cough, fever, diarrhea, body aches, loss of smell, or dyspnea. These patients would meet COVID-19 testing criteria at our institution while receiving immunosuppression.Patients with positive and presumed-positive results (n = 5) Patients with symptoms and positive COVID-19 PCR test result2 (8)2 (40) Patients with symptoms and negative COVID-19 PCR test result9 (36)1 (20)†Patient was evaluated by a primary care physician who believed that the patient had COVID-19. Patients with symptoms who were not tested for COVID-1914 (56)2 (40)†Patient was evaluated by a primary care physician who believed that the patient had COVID-19.IL, Interleukin; JAK, Janus kinase; PCR, polymerase chain reaction; TNF, tumor necrosis factor.∗ Symptoms include any patient-reported symptom of cough, fever, diarrhea, body aches, loss of smell, or dyspnea. These patients would meet COVID-19 testing criteria at our institution while receiving immunosuppression.† Patient was evaluated by a primary care physician who believed that the patient had COVID-19. Open table in a new tab IL, Interleukin; JAK, Janus kinase; PCR, polymerase chain reaction; TNF, tumor necrosis factor. As one of the hot spots of viral spread in the United States, Boston and the surrounding areas are ideal locations for studying effects of viral transmission. At data collection, slightly greater than 1% of Massachusetts residents had received a diagnosis of COVID-19, and slightly fewer than 10% of these patients required hospitalization.4Massachusetts Department of Public HealthInformation on the outbreak of coronavirus disease 2019 (COVID-19).https://www.mass.gov/resource/information-on-the-outbreak-of-coronavirus-disease-2019-covid-19Date: 2020Date accessed: May 8, 2020Google Scholar These numbers were similar in our patient population, with only 5 infections and 1 hospitalization, suggesting that the risk of both COVID-19 and poor outcomes is minimally affected by dermatologic immunomodulatory medications. However, many patients were successfully isolating to a large degree, and the low infectious rates appear to be due, at least in part, to enhanced social distancing efforts. As has been proposed previously,5Schett G. Sticherling M. Neurath M.F. COVID-19: risk for cytokine targeting in chronic inflammatory diseases?.Nat Rev Immunol. 2020; 20: 271-272Crossref PubMed Scopus (265) Google Scholar our findings suggest that when combined with patient education and encouragement to minimize exposure risks, systemic immunomodulatory therapies for dermatologic indications can be safely continued during the COVID-19 pandemic. Limitations include the unknown number of asymptomatic infections, lack of available confirmatory COVID-19 testing in some cases, and the effect of social distancing as a confounding factor on infection rates. Also, our practice consists of only adult patients. Despite these limitations, we did not observe evidence of increased infectious risk, and we hope that these data will inform treatment decisions for patients who need these medications despite the ongoing COVID-19 pandemic.

Psoriasis plaques often recur in the same region and sometimes in the exact area of previous lesions. Some authors have demonstrated that sentinel primed dendritic cells permanently geolocate the areas of the skin, which may explain these areas of relatively exact recurrence. Moreover, persistent structural and immunologic gene changes, a “molecular scar,” have been identified in healed psoriatic lesions post-therapy. Field effects due to local microbiome or other environmental factors may also explain recurrence tendency in the same general area. To explore this phenomenon, we asked patients to recall their lesion distribution history. 42 patients at an academic institution and private practice in Massachusetts and New Jersey were queried with an IRB approved survey in 2017. All patients had dermatologist-diagnosed psoriasis at time of survey. The majority of respondents were male (64%; n = 27) and average age was 52 years old. Most subjects experienced initial psoriasis on the arms or legs (n = 23, 55%). When asked where psoriasis recurred post-treatment, 21% described “same place” recurrence and 66% described it as occurring in the “same place and some new places.” Only 5% described occurring in new places. Subjects who first experienced scalp disease were likely to experience scalp recurrence. Patients with groin disease with expansion were highly likely to expand into the groin area. Our study supports persistent local site activation of psoriasis, particularly at areas with a differential microbiome such as the scalp and groin. These findings may be useful in counseling patients about possible disease extension.

To the Editor: We recently read with great interest Albrecht et al's commentary on how US Food and Drug Administration (FDA) indications limit treatment access.1Albrecht J. Adamson A.S. Barbieri J.S. et al.Lack of a US Food and Drug Administration indication should not limit access to appropriate treatment.J Am Acad Dermatol. 2019; 80: 577-578Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar Insurance companies frequently utilize FDA guidelines and drug compendia to dictate treatment coverage; however, these resources are frequently outdated and lacking in scope.2Barbieri J.S. St Claire K. Mostaghimi A. Albrecht J. Evaluation of clinical compendia used for Medicare Part D coverage determinations for off-label prescribing in dermatology.JAMA Dermatol. 2019; 155: 315-320Crossref PubMed Scopus (7) Google Scholar We agree that treatment coverage should not be restricted by FDA approval. To lend further credence to their declaration, herein we provide evidence of disparity in prior authorization (PA) rates between diseases with and without an FDA-indicated treatment. We performed an IRB-approved, single-center retrospective review of PAs submitted at an academic center dermatology clinic over 6 months in 2017. PA data recorded included medication, dose, disease, PA decision, and post–PA-denial action. Prescriptions were excluded if PAs were unnecessary or no record of the PA decision was available. PA approval rate was calculated for all conditions seen in our dermatology department and stratified according to whether or not each disease had at least 1 FDA-indicated treatment. Additionally, 4 diseases with an FDA-indicated treatment (acne vulgaris, atopic dermatitis, hidradenitis suppurativa [HS], and psoriasis) and 3 diseases without an FDA-indicated treatment (alopecia, contact dermatitis, and vitiligo) were selected for comparative analysis of PA approval rates. Further, for acne, atopic dermatitis, HS, and psoriasis, PA approval rates were compared between medications prescribed on-label and off-label in each disease. A chi-square test was utilized to determine statistical significance, set at P < .05 a priori. A total of 722 PAs were included in this study. Overall approval rates for all dermatologic conditions seen in our clinic were significantly higher for diseases with an FDA-indicated treatment option compared with diseases without an FDA-indicated treatment (78.7% vs 57.1%) (χ2 = 32.30, P < .0001) (Table I). Additionally, a significantly higher approval rate was observed for acne, atopic dermatitis, psoriasis, and HS compared with that for contact dermatitis, vitiligo, and alopecia (81.6% vs 44.2%) (χ2 = 31.86, P < .0001) (Table I). Medications prescribed on-label for acne, atopic dermatitis, psoriasis, and HS were approved significantly more often than medications prescribed off-label (82.6% vs 68.4%) (χ2 = 4.60, P = .032) (Table II).Table IPrior authorization approval rates for diseases with at least 1 FDA-indicated treatment versus diseases without an FDA-indicated treatment, regardless of on- or off-label status of prescriptionAll prescriptionsDiseases with an FDA-indicated treatment availableDiseases without an FDA- indicated treatment availableTotalPA approved425 (78.7)∗Data are provided as n (%).104 (57.1)529 (73.3)PA denied115 (21.3)78 (42.9)193 (26.7)Selected diseases with an FDA-indicated treatmentAcneAtopic dermatitisHidradenitis suppurativaPsoriasisTotalPA approved202 (91.4)45 (66.2)8 (53.3)86 (75.4)341 (81.6)PA denied19 (8.6)2 (33.8)7 (46.7)28 (24.6)77 (18.4)Selected diseases without an FDA-indicated treatmentAlopeciaContact dermatitisVitiligoTotalPA approved4 (36.4)11 (61.1)4 (28.6)19 (44.2)PA denied7 (63.6)7 (38.9)10 (71.4)24 (55.8)FDA, US Food and Drug Administration; PA, prior authorization.∗ Data are provided as n (%). Open table in a new tab Table IIPrior authorizations for on-label and off-label prescriptions in selected diseases with a FDA-indicated treatment availableAcneAtopic dermatitisHidradenitis suppurativaPsoriasisTotalOn-label prescriptions PA approved196 (91.6)∗Data are provided as n (%).43 (67.2)5 (62.5)70 (74.5)314 (82.6) PA denied18 (8.4)21 (32.8)3 (37.5)24 (25.5)66 (17.4)Off-label prescriptions PA approved6 (85.7)2 (50.0)3 (42.9)15 (75.0)26 (68.4) PA denied1 (14.3)2 (50.0)4 (57.1)5 (25.0)12 (31.6)FDA, US Food and Drug Administration; PA, prior authorization.∗ Data are provided as n (%). Open table in a new tab FDA, US Food and Drug Administration; PA, prior authorization. FDA, US Food and Drug Administration; PA, prior authorization. Our data illustrate that FDA indication impacts insurers' decisions on medication coverage. This is not unique to the United States; a study in Germany found a similar initial approval rate (56.8%) for off-label therapies.3Seidenschnur K.E.K. Dressler C. Weller K. Nast A. Werner R.N. Off-label prescriptions and decisions on reimbursement requests in Germany—a retrospective analysis.J Dtsch Dermatol Ges. 2017; 15: 1103-1109PubMed Google Scholar Even in some diseases with an available FDA-indicated treatment, such as HS, approval rates were still low; in HS, for example, only 53.3% of PAs were initially approved. One limitation of our study is that our analyses did not detect scenarios in which a PA was submitted for an FDA-indicated treatment but was denied because the patient did not meet severity criteria to qualify for that medication. In summary, we advocate for development of more inclusive coverage algorithms to ensure that patients, particularly those with diseases for which there are no or few FDA-indicated medications, have access to efficacious treatments. Lack of a US Food and Drug Administration indication should not limit access to appropriate treatmentJournal of the American Academy of DermatologyVol. 80Issue 2PreviewEditorials in the Journal of the American Academy of Dermatology are not usually intended to be used in a prior approval packet. This one is different. Full-Text PDF