Zusammenfassung Atopische Dermatitis (AD) ist eine häufige, chronisch-entzündliche Hauterkrankung, die durch eine komplexe Pathogenese, klinische Heterogenität und einen schubhaften Verlauf gekennzeichnet ist. Vor allem die Behandlung von mittelschweren bis schweren Formen stellt eine Herausforderung dar, die bislang durch eine begrenzte Auswahl an Behandlungsoptionen zusätzlich erschwert wurde. Die Entwicklung neuer zielgerichteter Systemtherapien hat die Therapiemöglichkeiten deutlich erweitert und verbessert. Diese Neuerungen, unterstützt durch evidenzbasierte Ergebnisse aus klinischen Studien, signalisieren einen Wandel in der Behandlung der AD. Diese Übersicht gibt einen Überblick über die praxisrelevanten Fortschritte, einschließlich wichtiger Studienergebnisse, zur Wirksamkeit und Sicherheit von innovativen Systemtherapien bei AD.

Nail psoriasis is highly prevalent among patients with psoriasis yet remains one of the most challenging areas to treat. To better understand the treatment landscape for psoriatic nail disease, more studies are needed that compare the effectiveness of different biologics for patients with nail psoriasis. This study contributes to this objective by directly comparing the effectiveness of approved biologics in improving nail psoriasis for patients up to month 12 in a real-world setting. Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. This study assessed the change in modified Nail Psoriasis Severity Index (mNAPSI) score from baseline to months 3, 6 and 12 for 763 patients and compared the effectiveness of anti-interleukin (IL)-17A biologics versus other approved biologics, as well as ixekizumab versus secukinumab, guselkumab, risankizumab and adalimumab. Comparative adjusted analyses used frequentist model averaging (FMA). Least square mean difference (LSMD) in mNAPSI scores are presented as observed. Irrespective of the severity of nail psoriasis at baseline, the anti-IL-17A cohort had greater mean mNAPSI reductions from baseline compared to the other biologics cohort through month 12, reaching significance at months 3 and 6 in the adjusted analysis. For patients with moderate-to-severe nail psoriasis, ixekizumab showed numerically higher mean reductions in mNAPSI scores compared to all other studied biologics, reaching significance versus guselkumab at all timepoints and risankizumab at month 6. This real-world study showed that patients with moderate-to-severe psoriasis and any severity of concomitant nail involvement had significantly faster and more substantial improvements in nail psoriasis up to month 6 in the anti-IL-17A cohort compared to the other biologics cohort. Of the individual biologics studied, ixekizumab showed the highest numerical improvements in nail psoriasis at month 12. EUPAS24207.

Despite the abundance of data concerning biologic treatments for patients with psoriasis, clinicians are often challenged with discerning the optimal treatment for each patient. To inform this selection, this study explored whether a patient’s baseline characteristics or disease profile could predict the likelihood of achieving complete skin clearance with biologic treatment. Machine-learning and other statistical methods were applied to the substantial data collected from patients with moderate-to-severe psoriasis in the ongoing, international, prospective, observational Psoriasis Study of Health Outcomes (PSoHO). The 3 measures of complete skin clearance were a psoriasis area and severity index (PASI)100 response at (a) week 12, (b) month 12, and (c) week 12 and maintain ed at month 6 and month 12 (PASI100 durability). From these real-world data, the absence of nail psoriasis emerged as the most consistent feature that may be used by clinicians to predict high-level treatment responses with biologic treatment. Other significant predictors of skin clearance with biologic treatments were the absence of hypertension and a lower body surface area affected by psoriasis. Overall, this study evidences the substantial challenge of identifying reliable clinical markers of treatment response for patients with psoriasis and highlights the importance of regular screening for psoriatic nail involvement.

Atopische Dermatitis (AD) ist eine häufige, chronisch-entzündliche Hauterkrankung, die durch eine komplexe Pathogenese, klinische Heterogenität und einen schubhaften Verlauf gekennzeichnet ist. Vor allem die Behandlung von mittelschweren bis schweren Formen stellt eine Herausforderung dar, die bislang durch eine begrenzte Auswahl an Behandlungsoptionen zusätzlich erschwert wurde. Die Entwicklung neuer zielgerichteter Systemtherapien hat die Therapiemöglichkeiten deutlich erweitert und verbessert. Diese Neuerungen, unterstützt durch evidenzbasierte Ergebnisse aus klinischen Studien, signalisieren einen Wandel in der Behandlung der AD. Diese Übersicht gibt einen Überblick über die praxisrelevanten Fortschritte, einschließlich wichtiger Studienergebnisse, zur Wirksamkeit und Sicherheit von innovativen Systemtherapien bei AD.

Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12 months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting. The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90

Cette analyse intermédiaire décrit les manifestations du psoriasis unguéal (PU) à l’inclusion et les améliorations à 12 mois (M 12) chez 1 981 patients recrutés dans l’étude Psoriasis Study of Health Outcomes (PSoHO) de cohorte non interventionnelle prospective internationale menée sur 3 ans. Nous y comparons l’efficacité des traitements biologiques ciblant l’interleukine-17A (anti-IL-17A) et d’autres traitements biologiques approuvés pour traiter le PU en situation réelle, et évaluons les manifestations et améliorations unguéales de l’inclusion jusqu’à M 12 chez des patients atteints de psoriasis modéré à sévère. Des adultes atteints de psoriasis modéré à sévère depuis ≥ 6 mois et commençant un traitement biologique ou en changeant ont été recrutés. À l’inclusion, le PU, évalué à l’aide du score mNAPSI (version modifiée du Nail Psoriasis Severity Index), a été classé comme présent (mNAPSI ≥ 1) ou absent (mNAPSI = 0). Cette analyse comprend les données des patients à l’inclusion et le score mNAPSI à M 12. Les améliorations à M 12 ont été définies comme la proportion de patients atteignant une amélioration de 50 ou 100 % du score mNAPSI (mNAPSI 50/100). Les données à l’inclusion ont été analysées selon la méthode ANOVA ou le test exact de Fisher. Les données à M 12 ont été analysées de manière descriptive avec imputation en non-réponse. Parmi les patients atteints de PU (n = 263) à l’inclusion, 46,8 % (n = 123/263) ont reçu un traitement par anti-IL-17A (ixékizumab: 76,4 % [n = 94], sécukinumab: 23,6 % [n = 29]) et 53,2 % (n = 140/263) ont reçu d’autres traitements biologiques. Les patients atteints de PU présentaient des dermatoses plus sévères (PASI: 16,4 [8,9] vs 14,2 [9,3]; p = 0,013) et des taux plus élevés de rhumatisme psoriasique (29,7 % vs 14,0 %; p < 0,001) que les patients qui n’avaient pas de PU. De plus, les patients atteints de PU avaient un score mNAPSI moyen (ET) de 24,8 (21,9), 47,9 % (n = 126/263) avaient un PU modéré à sévère (mNAPSI≥ 20), et les caractéristiques du PU les plus fréquentes étaient l’onycholyse/dyschromie avec un aspect en tâches d’huile (78,3 % [n = 206/263]) et les dépressions ponctuées (77,9 % [n = 205/263]). À M 12, le score mNAPSI 50/100 a été atteint par respectivement 85,4 %/55,3 % de patients traités par anti-IL-17A et 72,1 %/42,9 % de patients traités par d’autres traitements biologiques. Des résultats similaires ont été observés chez les patients avec un score mNAPSI ≥ 20 à l’inclusion. Dans cette analyse intermédiaire, des proportions élevées de patients traités par anti-IL-17A ont présenté des améliorations du PU à M 12 en situation réelle, ce qui est cohérent avec les résultats d’études cliniques.

Background: Aim Report the comorbid conditions and concomitant medications of biologic-treated patients with moderate-to-severe psoriasis (PsO) in a real-world setting.

Abstract Background Baricitinib is an oral selective Janus kinase 1/2 inhibitor approved for moderate-to-severe atopic dermatitis (AD) in adults. Objectives To evaluate absolute Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD) outcomes over 16 weeks and to link disease severity categories to quality of life (QoL) improvements. Methods This post-hoc analysis included patients enrolled in Phase3 monotherapy (BREEZE-AD1/AD2) and topical corticosteroid (TCS) combination therapy (BREEZE-AD7) trials and analyzed baricitinib 2 and 4 mg vs. placebo. Categorical outcomes were analyzed using Fisher’s exact test. Results Significantly more baricitinib-treated patients reached EASI ≤ 7 and SCORAD < 25 as early as week 1 in monotherapy and week 2 in TCS combination therapy, compared to placebo. Significant response vs. placebo was sustained until week 16 for EASI ≤ 7 (AD1/2 [p-value vs. placebo]: 2 mg = 19.9%, 4 mg = 25.4% [p = 0.001] and AD7: 2 mg = 40.4% [p = 0.087], 4 mg = 48.6% [p = 0.003]) and SCORAD < 25 (AD1/2: 2 mg = 12.2%, 4 mg = 19.4% [p = 0.001] and AD7: 2 mg = 30.3% [p = 0.025], 4 mg = 34.2% [p = 0.004]) severity categories. These effects were accompanied by rapid improvements in QoL. Conclusion Baricitinib-treated patients rapidly achieved recommended absolute EASI and SCORAD treatment outcomes which were sustained until week 16. Improvements in QoL were greater than EASI severity categories reflected, indicating that physician-assessed scores do not necessarily correlate with patients’ impression of AD severity.

Atopic dermatitis (AD) is a chronic, inflammatory skin disorder that impairs patients’ quality of life (QoL). Physician assessment of AD disease severity is determined by clinical scales and assessment of affected body surface area (BSA), which might not mirror patients’ perceived disease burden. Using data from an international cross-sectional web-based survey of patients with AD and a machine learning approach, we sought to identify disease attributes with the highest impact on QoL for patients with AD. Adults with dermatologist-confirmed AD participated in the survey between July–September 2019. Eight machine learning models were applied to the data with dichotomised Dermatology Life Quality Index (DLQI) as the response variable to identify factors most predictive of AD-related QoL burden. Variables tested were demographics, affected BSA and affected body areas, flare characteristics, activity impairment, hospitalisation and AD therapies. Three machine learning models, logistic regression model, random forest and neural network, were selected on the basis of predictive performance. Each variable’s contribution was computed via importance values from 0 to 100. For relevant predictive factors, further descriptive analyses were conducted to characterise those findings. In total, 2314 patients completed the survey with mean age 39.2 years (standard deviation 12.6) and average disease duration of 19 years. Measured by affected BSA, 13.3

Background: Rapid skin improvement is a key treatment goal of patients with moderate-to-severe psoriasis (PsO). Objectives: To compare the speed of clinical improvement of approved biologics on the symptoms and signs of psoriasis assessed by patients using the validated Psoriasis Symptoms and Signs Diary (PSSD) through 12 weeks. Methods: Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional study that compares the effectiveness of anti-interleukin (IL)-17A biologics versus other biologics, together with pairwise comparisons of ixekizumab versus five individual biologics in patients with PsO. Using the PSSD 7-day recall period, patients assessed the symptoms (itch, skin tightness, burning, stinging and pain) and signs (dryness, cracking, scaling, shedding/flaking, redness and bleeding) of their psoriasis (0-10). Symptom and sign summary scores (0-100) are derived from the average of individual scores. Percentage change in summary scores and proportion of patients with clinically meaningful improvements (CMI) in PSSD summary and individual scores are evaluated weekly. Longitudinal PSSD data are reported as observed with treatment comparisons analysed using mixed model for repeated measures (MMRM) and generalized linear mixed models (GLMM). Results: Across cohorts and treatments, eligible patients (n = 1654) had comparable baseline PSSD scores. From Week 1, the anti-IL-17A cohort achieved significantly larger score improvements in PSSD summary scores and a higher proportion of patients showed CMIs compared to the other biologics cohort through 12 weeks. Lower PSSD scores were associated with a greater proportion of patients reporting their psoriasis as no longer impacting their quality-of-life (DLQI 0,1) and a high level of clinical response (PASI100). Results also indicate a relationship between an early CMI in PSSD score at Week 2 and PASI100 score at Week 12. Conclusions: Treatment with anti-IL-17A biologics, particularly ixekizumab, resulted in rapid and sustained patient-reported improvements in psoriasis symptoms and signs compared with other biologics in a real-world setting.

Early prediction of therapeutic response can optimize treatment strategies in atopic dermatitis (AD). Using baricitinib data from one topical corticosteroid combination study and pooled data from two monotherapy studies in patients with moderate-to-severe AD, we calculated the sensitivity, specificity, and positive and negative predictive values, of predefined changes in single and combined clinical scores at weeks 2, 4 and 8 to predict a clinical response at week 16. We found that improvement in composite measures of signs and symptoms early during treatment with baricitinib 4 mg predicts clinical response at week 16, providing a tool for dermatologists in choosing treatment strategies for patients with moderate-to-severe AD. Background Early prediction of therapeutic response can optimize treatment strategies in atopic dermatitis (AD). Baricitinib is approved for moderate-to-severe AD in Europe, Japan and other countries. Objectives To identify early clinical improvements that can reliably predict a later clinical response to baricitinib in adults with moderate-to-severe AD. Methods Using data from one topical corticosteroid combination study [BREEZE-AD7 (NCT03733301)] and data pooled from two monotherapy studies [(BREEZE-AD1 (NCT03334396) and BREEZE-AD2 (NCT03334422)], we calculated the sensitivity and specificity, along with the positive predictive value (PPV) and negative predictive value (NPV), of predefined changes in single and combined clinical scores at weeks 2, 4 and 8, to predict clinical response at week 16. Clinical response was defined as >= 75% improvement in Eczema Area and Severity Index (EASI 75), >= 4-point improvement in Itch Numeric Rating Scale (Itch NRS >= 4), or a combination of both. Results Composite predictors had higher predictive accuracy for week 16 response outcomes than did single parameters. This was evident as early as week 4 for the combination of EASI 50 or Itch NRS >= 3 and of validated Investigator Global Assessment for AD (vIGA-AD) score <= 2 or Itch NRS >= 3 (sensitivity 87-100%; NPV 68-100%). The predictive accuracy of these composite clinical predictors for week 16 response outcomes was highest at week 8 (sensitivity 92-100%; NPV 80-100%). At both weeks 4 and 8, EASI 50 or Itch NRS >= 3 had higher sensitivity and NPV than did vIGA-AD score <= 2 or Itch NRS >= 3. Conclusions Improvement in signs and symptoms early during treatment with baricitinib 4 mg once daily predicts clinical response at week 16, providing a tool for dermatologists when choosing treatment strategies for patients with moderate-to-severe AD.

Background: This interim analysis describes nail psoriasis (NP) manifestations at baseline and improvements up to Month 12 (M12) in 1981 patients enrolled in the Psoriasis Study of Health Outcomes (PSoHO), a 3-year, international, prospective, non-interventional cohort study.

Introduction Psoriasis localized at the scalp, face, nails, genitalia, palms, and soles can exacerbate the disease burden. Real-world studies comparing the effectiveness of treatments for these special areas are limited. Methods Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional, study comparing the effectiveness of anti-interleukin (IL)-17A biologics (ixekizumab and secukinumab) compared to other approved biologics and the pairwise comparative effectiveness of ixekizumab relative to five other individual biologics for patients with moderate-to-severe psoriasis. To determine special area involvement, physicians answered binary questions at baseline and week 12. The proportion of patients who achieved special area clearance at week 12 was assessed. Missing outcome data were imputed as non-response. Comparative treatment analyses were conducted using frequentist model averaging. Results Of the 1,978 patients included, 83.4% had at least one special area involved at baseline with the scalp (66.7%) as the most frequently affected part, followed by nails (37.9%), face/neck (36.9%), genitalia (25.6%), and palms and/or soles (22.2%). Patients with scalp, nail, or genital, but not palmoplantar or face/neck psoriasis, had significantly higher odds of achieving clearance at week 12 in the anti-IL-17A cohort compared to the other biologics cohort. Patients with scalp psoriasis had a 10–20% higher response rate and significantly greater odds (1.8–2.3) of achieving clearance at week 12 with ixekizumab compared to included biologics. Conclusion Biologics demonstrate a high level of clearance of special areas at week 12 in a real-world setting. Patients with scalp, nail, or genital involvement have significantly higher odds of clearance at week 12 with anti-IL-17A biologics compared to other biologics.

Limited data exist on skin cancer risk in patients with psoriasis using biologics. Here, we report treatment-emergent adverse events (TEAEs) of skin cancer in patients treated with ixekizumab from psoriasis clinical trials. Integrated safety databases from 17 clinical trials of adults with moderate-to-severe psoriasis treated with ≥ 1 dose of ixekizumab for ≤ 5 years were used to analyze exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) and clinically characterize dermatologist-adjudicated skin cancer TEAEs. Of 6892 patients, 58 presented with ≥ 1 skin cancer TEAE (IR 0.3) with IRs remaining stable with longer ixekizumab exposure. Non-melanoma skin cancer (NMSC) was the most common event (IR 0.3) affecting 55 patients; of those, 44 had basal cell carcinoma (IR 0.2) and 16 had squamous cell carcinoma (IR 0.1). Two treatment-emergent melanoma events were identified; neither were classified as serious AEs. Incidence of skin neoplasms in patients with psoriasis treated with ixekizumab for ≤ 5 years was low, and among those events, NMSC was most common. Limitations included that longer exposure may be required to confirm risk of skin cancer and that the study exclusion criteria of several studies, which excluded patients with skin cancer events within 5 years prior to baseline, might limit interpretation of skin cancer risk in this cohort. These findings support the safety profile of ixekizumab for patients requiring long-term psoriasis control.

INTRODUCTION:We explored patient satisfaction with baricitinib, an oral Janus kinase inhibitor, in patients with atopic dermatitis (AD) treated in routine clinical practice. METHODS:Adults with moderate-to-severe AD treated with baricitinib in clinical practice for ≥4 weeks in France, Germany, and the UK completed a one-time online survey under market research methodologies. Treatment satisfaction was assessed using a Likert scale and abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9). Patients reported demographic, disease, and treatment information. Data were analyzed descriptively. RESULTS:The survey was completed by 170 patients with a mean age of 39.3 years (SD = 13.5), 59% (n = 101) were female. At baricitinib initiation, 79% rated their AD as "Severe", yet 28% reported body surface area (BSA) involvement ≥10%. Most were "Satisfied" or "Very satisfied" (76%/18%) with baricitinib, with high rates reported for controlling itch (36%/56%). Itch improvements were noted by 97% of patients. Some tapered/stopped (50%/32%) topical corticosteroid use, aligned with reported improvements on the patient global assessment and BSA. Mean TSQM-9 convenience score was 78.0 (SD = 14.0). CONCLUSIONS:Satisfaction with itch control was particularly high, reflected in rates of improvement in itch since starting baricitinib. On the TSQM-9, the convenience score was the highest. Many patients tapered/stopped concomitant topicals, indicating baricitinib's effect in controlling AD symptoms.

BACKGROUND:Biologic drugs are generally recommended for treating moderate-to-severe psoriasis. While eligibility criteria are primarily defined by clinical treatment guidelines, access to these therapies varies between European countries and is regulated by country-specific reimbursement criteria. This post-hoc subgroup analysis of integrated data from two phase III trials (UNCOVER-2 and -3) reports the efficacy of ixekizumab relative to that of etanercept in patients with moderate-to-severe plaque psoriasis selected into groups defined by original reimbursement criteria from eight European countries. METHODS:This analysis included baseline and 12-week data from the ixekizumab- and etanercept-treated study populations from UNCOVER-2 and -3. Patients were classified as meeting/not meeting each country-specific biologic eligibility criterion. Efficacy was defined by Psoriasis Area and Severity Index (PASI) 75, 90, and 100 response rates and by Dermatology Life Quality Index (DLQI) (0,1) response rates. Treatment responses across subgroups were analysed using logistic regression models. RESULTS:PASI 75/90/100 response rates were significantly higher for ixekizumab-treated patients than for etanercept-treated patients at week 12 (P&lt;0.05), irrespective of whether predefined reimbursement criteria were met, for all countries, with the exception of PASI 100 response in those meeting reimbursement criteria in Belgium, where sample size was very small. Clinical efficacy outcomes were corroborated by proportions of patients achieving DLQI (0,1) responses. CONCLUSIONS:The overall high efficacy of ixekizumab, and the consistency of the higher treatment effect compared with etanercept, in patients with moderate-to-severe psoriasis across a range of European biologic treatment reimbursement eligibility criteria provides new insights to inform treatment decisions in clinical practice. J Drugs Dermatol. 2022;21(6):659-667. doi:10.36849/JDD.6620.

In clinical practice, interruption of treatment may not result in immediate cessation of disease control, and some patients even experience sustained treatment response following treatment interruption. This post hoc analysis of UNCOVER-1 and -2 Phase 3 clinical trials characterized the time to loss of treatment response in patients with psoriasis who responded to ixekizumab through a 12-week treatment period, and who were then re-randomized to placebo for the following 48 weeks. For those with static Physician Global Assessment [sPGA]0/1 and Psoriasis Area and Severity Index [PASI]90 at Week 12, the median time to loss of PASI90 was 16.1 weeks (95% confidence interval 12.7–16.4). For those with PASI100 at Week 12, the median time to loss of PASI100 was 12.1 weeks (95% confidence interval 9.0–13.0). A small subset of patients maintained high levels of disease control through Week 60. This study adds to the growing body of evidence on sustained treatment response following treatment interruption.

Background Clinical trials study treatment outcomes under stringent conditions, capturing incompletely the heterogeneity of patient populations and treatment complexities encountered in real-world practice. Objectives To compare the effectiveness of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis. Methods The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year observational cohort study in adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. Primary study endpoint is the proportion of patients achieving 90% improvement in Psoriasis Area and Severity Index (PASI 90) and/or static Physician Global Assessment (sPGA) 0/1 at Week 12 (W12) in the anti-IL-17A cohort (ixekizumab [IXE], secukinumab) vs. all other approved biologics. Secondary outcomes include the proportion of patients who achieve PASI 75/90/100, absolute PASI scores <= 5, <= 2 and <= 1, Dermatology Life Quality Index (DLQI) score of 0/1 at W12 between the two cohorts and among the individual biologics. Comparative effectiveness analyses were conducted using Frequentist Model Averaging (FMA), a novel causal inference machine learning approach. Missing data for binary outcomes were imputed as non-response. Results Patient profiles in the anti-IL-17A cohort and other biologics cohort were similar, with more frequent comorbid psoriatic arthritis and less frequent exposure to conventional treatments in the patients receiving anti-IL-17A biologics. At W12, 71.4% of patients who received an anti-IL-17A biologic achieved PASI 90 and/or sPGA 0/1 compared to 58.6% of patients who received other biologics (odds ratios [OR], 1.9; 95% confidence intervals [CI], [1.6, 2.4]). Similar findings were observed for secondary outcomes. Conclusions These results reflect the high efficacy and early onset of skin clearance of IL-17A inhibitors observed in randomized clinical trials and confirm the effectiveness of anti-IL-17A biologics in the real-world setting.

Background Psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are chronic inflammatory diseases that often affect women of childbearing age. Detailed information about pregnancy and related outcomes across these indications in patients exposed to ixekizumab is lacking. Objectives To evaluate pregnancy outcomes after maternal or paternal exposure to ixekizumab in patients with psoriasis, PsA, or axSpA. Methods Pregnancy cases from clinical trials and post-marketing reports, associated with either maternal or paternal exposure to ixekizumab cumulatively through 22 March 2019, were identified in the Eli Lilly Global Safety Database and described separately. Results One hundred and ninety-three ixekizumab-exposed pregnancies were identified. Maternal exposure occurred in 51.3% of pregnancies (clinical trials: n = 58; post-marketing: n = 41). The majority of paternal exposure pregnancies occurred in clinical trials (91 of 94). Live births were reported for 53.8 and 61.1% of known outcomes in maternal exposure pregnancies during clinical trials and post-marketing surveillance, respectively. No congenital malformations resulting from maternal exposure were reported in clinical trials: one case, not causally related to ixekizumab therapy, was recorded in the post-marketing setting. Conclusions This integrated safety analysis provides relevant information for clinicians treating patients with psoriasis, PsA, or axSpA with ixekizumab. No new safety signals were identified in patients receiving ixekizumab.