Baricitinib and ritlecitinib are approved targeted therapies for severe alopecia areata (AA), but direct comparative real-world data remain limited. This monocentric retrospective study evaluated the treatment profile, effectiveness, and safety of both agents in routine clinical practice. We included 160 patients with severe AA, defined by a Severity of Alopecia Tool (SALT) score ≥ 50, treated with baricitinib 4 mg (n = 110) or ritlecitinib 50 mg (n = 50). Clinical outcomes were assessed at baseline, week 16, and week 52; week 104 data were available for baricitinib. The primary endpoint was achieving SALT ≤ 20 at week 52. Secondary outcomes included SALT ≤ 20 at weeks 16 and 104, improvement in eyebrow and eyelash involvement assessed using clinician-reported outcome (ClinRO) measures, treatment discontinuation, and safety. Both treatments were associated with progressive clinical improvement through week 52. SALT ≤ 20 response rates were comparable for baricitinib and ritlecitinib at week 16 (39.6
BACKGROUND:The clinical definition of moderate psoriasis is debated, affecting treatment eligibility and patient outcomes. OBJECTIVE:A panel of Italian dermatologists aimed to propose practical criteria to define moderate psoriasis, based on a comprehensive literature review and clinical experience. METHODS:The panel reviewed publications between 2016 and 2024 focusing on key severity scores, including the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), and Physician's Global Assessment (PGA), along with special area involvement and patient-reported outcomes. RESULTS:Despite variability among studies, and the lack of universally accepted thresholds, the panel defined moderate psoriasis as a BSA of 5%-10%, DLQI of 5-10, a PGA score of 3, and involvement of at least two special areas (e.g. scalp, face, genitals, nails, hands, or feet). Distressing itch and psychosocial impact were also recognized as critical elements influencing perceived disease burden. A composite PGA-based approach, integrating objective measures with patient-centered criteria, is proposed for identifying patients with moderate psoriasis who may benefit from systemic therapy. CONCLUSION:This pragmatic approach may help bridge the gap between guidelines and real-world clinical practice, ensuring more accurate treatment allocation and reducing undertreatment of psoriasis.
Background: Psoriasis involving difficult-to-treat anatomical areas, such as the scalp, genitalia, fingernails, and palmoplantar regions, carries a disproportionate disease burden and often requires systemic therapy. In this context, real-life data comparing the long-term effectiveness of tildrakizumab 100 mg versus 200 mg in patients with difficult-to-treat psoriasis remain limited. Methods: This multicenter retrospective observational study included adult patients in three Italian dermatology centers. Global efficacy endpoints included PASI75, PASI90, PASI100, and absolute PASI ≤ 2 at weeks 16, 32, 52, and 104. Site-specific effectiveness was assessed as complete clearance (PGA = 0) in patients with baseline involvement (PGA ≥ 2) of difficult-to-treat areas. Outcomes were described by dose. Results: 183 patients were included (100 mg: n = 89; 200 mg: n = 94). Patients receiving 200 mg had higher baseline BMI and were more frequently biologic-experienced. At week 104, PASI75 was achieved by 94.2% of patients receiving 100 mg and 94.7% receiving 200 mg, while PASI90 and PASI100 were achieved by 82.7% vs. 57.9% and 48.1% vs. 47.4%, respectively. Clearance of difficult-to-treat areas improved progressively across all sites. Scalp and genital psoriasis showed higher and earlier clearance rates, whereas nail and palmoplantar psoriasis showed slower and more heterogeneous responses. No consistent dose-dependent advantage emerged, despite less favorable baseline characteristics in the 200 mg group. Conclusions: Over 104 weeks, tildrakizumab showed sustained long-term effectiveness in both global disease control and difficult-to-treat areas. The 200 mg dose, used in a more difficult-to-treat population, achieved comparable long-term outcomes, supporting dose optimization in clinical practice.
IntroductionT cell autoreactivity against the autoantigens LL37 and ADAMTSL5 contributes to inflammation in a subset of psoriatic patients. The immunological mechanisms underlying the treatment response in patients showing autoreactivity remain incompletely understood in clinical settings. This study investigated the impact of tildrakizumab on circulating immune populations and on autoantigen-specific T cell reactivity.MethodsPatients with moderate-to-severe psoriasis were enrolled and treated with tildrakizumab according to clinical practice. T cells autoreactivity to LL37 and ADAMTSL5 was assessed at baseline using a stimulation index (SI>2). Longitudinal changes in circulating T cell subsets were analyzed using multiparametric flow cytometry.ResultsTwenty of 38 psoriatic patients (52.6%) displayed circulating autoreactive T cells (SI>2) to LL37 and/or ADAMTSL5, compared with 5 of 33 healthy donors (15.2%). Baseline frequencies of Ki67+CD4+/CD8+, and IL-17+CD4+/CD8+ T cell populations positively correlated with PASI. Stimulation of PBMCs with LL37 or ADAMTSL5 induced Th17- and Th1-related cytokines, but not Th2-related cytokines. During treatment, tildrakizumab significantly modulated multiple circulating T cell subsets, including Ki67+CD4+, Ki67+CD8+, Ki67+Th17, Th17, and Ki67+Tregs, and markedly reduced autoreactivity to both autoantigens. Notably, clinical improvement strongly correlated with reductions in Ki67+CD4+ and Ki67+CD8+ T cell frequencies. LL37-reactive patients exhibited a poorer clinical response at weeks 40 and 52.ConclusionsIn autoreactive patients, tildrakizumab effectively modulated circulating T cell proliferation and reduced autoantigen-specific responses over time. LL37-reactive patients showed distinct long-term responses, suggesting that autoantigen-reactive subjects may represent a more treatment-challenging subgroup within the psoriatic population.
Atopic dermatitis (AD) is associated with a significant physical, psychological, social and economic burden and a decreased quality of life. There is a relationship between disease burden and the level of disease severity and control. The burden of AD largely depends on skin lesions, itch and sleep disturbances, although other aspects also play a role. Even though treat-to-target approaches have been proposed for AD in recent years, studies showed that many patients with AD continue to perceive disease burden despite the achievement of the established treatment targets. This prompted the conception of the Aiming High in Eczema/Atopic Dermatitis (AHEAD) recommendations, which included novel optimal targets for both clinician- and patient-reported outcomes, the achievement of which is defined as minimal disease activity or MDA. This narrative review appraises studies that show that the achievement of elevated treatment targets results in multiple benefits. Aiming high helps to achieve more in patients with AD.
Psoriasis is a chronic inflammatory skin disease characterized by keratinocyte hyperproliferation and immune activation. The SNP rs610604 within the TNFAIP3 locus is associated with increased psoriasis susceptibility and response to TNF-targeted therapies, yet its functional mechanism remains unclear. In this study, we identify, to our knowledge, a previously unreported regulatory axis linking IKKα to TNFAIP3 in keratinocytes and demonstrate how genetic variation at rs610604 modulates inflammatory signaling. Genome-wide chromatin profiling revealed that nuclear IKKα predominantly occupies transcriptionally inactive regions and acts as a chromatin-associated repressor. Among its targets, TNFAIP3 emerged as a key locus containing an IKKα-binding region overlapping the rs610604 variant. Functional analyses showed allele-specific recruitment of IKKα, with the psoriasis-risk G allele displaying stronger and more persistent binding than the protective T allele. This interaction promotes transcriptional repression of TNFAIP3, a negative regulator of NF-κB, MAPK, and IL-17 pathways, thereby sustaining proinflammatory signaling; consistently, in psoriatic lesions, nuclear IKKα is reduced. These findings identify a nuclear IKKα-TNFAIP3 axis linking genetic susceptibility to inflammatory signaling, providing a potential explanation for the paradox of chronic inflammation without frequent malignant transformation in psoriatic skin and highlighting IKKα as a potential therapeutic target in psoriasis and related inflammatory disorders.
BACKGROUND:Patients with moderate-to-severe atopic dermatitis (AD) require long-term management. Understanding the long-term safety of new treatments is a top priority for patients and healthcare professionals. OBJECTIVES:To evaluate the safety of tralokinumab in adults and adolescents with moderate-to-severe AD by conducting an integrated safety analysis of seven placebo-controlled trials and the ongoing, open-label extension study ECZTEND (NCT03587805). METHODS:An initial 16-week placebo-controlled (PBO-CTRL) safety set and an all-tralokinumab (ALL-TRALO) safety set combining the placebo-controlled trials and ECZTEND (data cutoff 30 April 2022) were analysed. All treatment-emergent adverse events were recorded. Adverse events of special interest (AESIs) were predefined. Safety areas of clinical interest for advanced systemic AD treatments were captured retrospectively. Proportions of patients with events and incidence rates (IRs) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as the time until the first event or exposure end, whichever came first, and incidence was defined as the first event. RESULTS:Safety results were similar between the PBO-CTRL safety set and ALL-TRALO safety set. In the latter, 2693 patients received tralokinumab for up to 238.5 weeks (approximately 4.5 years, PYE = 5320.2). Most adverse events (AEs) were nonserious, mild or moderate in severity, and occurred with similar frequencies between tralokinumab and placebo in the PBO-CTRL safety set. The most common AEs that occurred at higher rates for tralokinumab vs. placebo were nasopharyngitis [IR ratio (IRR) comparing tralokinumab vs. placebo 1.26], conjunctivitis (IRR 3.11) and injection site reaction (IRR 19.57). Dermatitis atopic and asthma occurred at lower rates with tralokinumab vs. placebo (IRR 0.51 and IRR 0.57, respectively). AESI eye disorders occurred at higher rates with tralokinumab vs. placebo (IRR 2.43) and 98% were mild to moderate. AESIs that were less frequent with tralokinumab vs. placebo included skin infections requiring systemic treatment (IRR 0.43) and eczema herpeticum (IRR 0.32). Rates of AEs of clinical interest (related to other approved systemic AD treatments) were low and similar between treatment groups. IRs of AEs did not increase with longer exposure in the ALL-TRALO safety set. CONCLUSIONS:Long-term use of tralokinumab in adults and adolescents with moderate-to-severe AD was well-tolerated and consistent with the initial placebo-controlled treatment period, with no new safety signals identified.
Background/Objectives: Palmoplantar psoriasis (PP) is a challenging variant of psoriasis that affects high-impact areas such as palms and soles and significantly impairs quality of life despite often limited body surface involvement. Conventional topical and systemic therapies may be insufficient, and evidence on biologic treatments for this specific phenotype remains limited. Bimekizumab (BKZ), a monoclonal antibody targeting IL-17A and IL-17F, has shown high efficacy in plaque psoriasis. This study aimed to evaluate the real-world effectiveness and rapidity of action of BKZ in patients with palmoplantar psoriasis compared with patients with psoriasis vulgaris (PV). Methods: We conducted a multicenter retrospective cohort study using data from 22 Italian dermatological units within the IL-PSO (Italian Landscape-Psoriasis) database. Adult patients treated with BKZ between November 2022 and October 2024 were included and categorized into three groups: isolated PP, PP associated with PV (PP + PV), and PV without palmoplantar involvement. Clinical outcomes included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and pruritus Visual Analogue Scale (VAS). Outcomes were assessed at baseline, week 4, and week 16. Results: A total of 47 patients were included. The baseline PASI was lower in the PP group compared with the PP + PV and PV groups, whereas the DLQI was highest in patients with isolated PP. Rapid clinical improvement was observed in all groups. The mean % PASI reduction at week 4 was 60.5%, 65.1%, and 77.0% in the PP, PP + PV, and PV groups, respectively, increasing to 94.8%, 90.4%, and 91.8% at week 16. The proportion of patients achieving complete clearance (PASI = 0) at week 16 was 73.3% (11/15), 68.2% (15/22), and 70.0% (7/10), respectively. Significant improvements were also observed in DLQI and pruritus scores over time. No significant safety concerns emerged. Conclusions: In this real-world multicenter cohort, bimekizumab demonstrated rapid and high efficacy in patients with palmoplantar psoriasis, both isolated and associated with psoriasis vulgaris. These findings support the use of BKZ as an effective therapeutic option for psoriasis involving high-impact areas, as the palmoplantar, although larger studies are needed to confirm these results.
Introduction: Bimekizumab (BKZ) has demonstrated long-term efficacy in patients (pts) with moderate to severe plaque psoriasis.1 Measuring response using absolute outcome scores may be clinically beneficial, as they are not influenced by baseline (BL) disease severity and provide a direct measure of current disease severity.2 We report improvements in absolute scores for psoriasis clinical outcomes through 4 years of BKZ treatment. Procedure: Data were pooled from BE VIVID/BE READY/BE SURE (NCT03370133/NCT03410992/NCT03412747) and their open-label extension (OLE) BE BRIGHT (NCT03598790). Included pts received BKZ 320 mg every 4 weeks (wks; Q4W) to Wk16, then Q4W or Q8W into OLE. Mean absolute Psoriasis Area and Severity Index (PASI), Investigator’s Global Assessment (IGA), body surface area (BSA) affected by psoriasis, and Dermatology Life Quality Index (DLQI) scores are reported to OLE Wk144 (Year4), using multiple imputation. Data were reported in all pts (BKZ Total), and in pts who received BKZ Q4W to Wk16 then Q8W (Q4W/Q8W). Results: Among 771 BKZ Total pts, mean BL scores were: PASI 21.1; IGA 3.3; BSA 27.0; DLQI 10.5 (Q4W/Q8W: PASI 20.4; IGA 3.3; BSA 24.5; DLQI 10.8). Mean Wk16/Year4 scores were: PASI 0.6/0.7; IGA 0.4/0.5; BSA 1.4/1.2; DLQI 1.3/0.9. Scores in the 197 Q4W/Q8W pts at Wk16/Year4 were similar (PASI 0.3/0.6; IGA: 0.3/0.3; BSA: 0.7/1.2; DLQI: 1.3/0.7). Conclusion: Improvements in mean absolute PASI, IGA, BSA, and DLQI were high by Wk16 and sustained through 4 years with BKZ.
Moderate psoriasis, despite its clinical relevance, remains inconsistently defined in current guidelines, leading to heterogeneous treatment decisions and variable access to systemic therapy. A unified, clinically meaningful definition is currently lacking. To establish a consensus-based, operational definition of moderate psoriasis, we conducted a two-round modified Delphi process involving expert dermatologists. Fifteen Italian dermatologists with recognized expertise in psoriasis participated in a Delphi survey composed of 18 statements addressing clinical severity, quality of life, symptoms, involvement of special areas, and treatment response. Consensus was defined as a median score ≥ 7 with interquartile range (IQR) ≤ 2, or ≥ 75
BACKGROUND:The therapeutic management of pyoderma gangrenosum (PG) is challenging. Conventional therapies, including systemic corticosteroids and cyclosporine, are limited by incomplete responses, frequent relapses, and cumulative toxicity. Emerging evidence supports a pathogenic role of the interleukin (IL)-23/IL-17 axis in PG, suggesting selective IL-23 inhibition as an appealing therapeutic approach. This study assessed the effectiveness, safety, steroid-sparing potential, and predictors of response to selective IL-23 inhibitors in conventional treatment-refractory PG. METHODS:This multicenter retrospective study included adult patients with refractory PG or intolerant to conventional systemic therapies, treated with selective IL-23 inhibitors (guselkumab, risankizumab, or tildrakizumab). Clinical assessments were performed at baseline and during follow-up (1, 3, 6, 12 months, and last observation), evaluating ulcer area, number of lesions, ulcer depth, border wound bed characteristics, Investigator's Global Assessment for PG (IGAPg), and pain intensity assessed by the Numerical Rating Scale (NRS). Longitudinal changes were analyzed using non-parametric tests for repeated measures. RESULTS:Selective IL-23 inhibition in 18 patients was associated with a progressive reduction in total ulcer area, significant from 1 month onward (p = 0.0069; all subsequent p ≤ 0.0003). The number of active ulcers did not change at 1 month (p = 0.41) but significantly decreased from Month 3 onward (p = 0.004 to < 0.001). Ulcer depth remained unchanged at 1 month (p = 0.41) and significantly improved from Month 3 onward (p = 0.01-0.046). Border/perilesional inflammation and wound bed characteristics showed significant improvement at all follow-up visits (p = 0.0008-0.034 and p = 0.013-0.046, respectively). IGAPg score showed a significant and progressive improvement over time (all p ≤ 0.027). Pain intensity showed a significant reduction during follow-up (p = 0.004 to < 0.001). A significant steroid-sparing effect was observed, with a progressive reduction in median daily prednisone-equivalent dose during follow-up (p = 0.002-0.014). Guselkumab and risankizumab showed comparable efficacy (p = 0.182). In univariate analysis, baseline ulcer depth was the only predictor of ulcer area reduction (p = 0.039). No unexpected safety signals were observed. CONCLUSIONS:Selective IL-23 inhibition appears to be a well-tolerated therapeutic option for refractory PG, providing meaningful clinical improvement and a relevant steroid-sparing effect. These findings support further controlled studies to define the role of IL-23 inhibitors within PG treatment algorithms.
Psoriasis is a chronic inflammatory skin disease associated with significant physical and psychological burden. Tildrakizumab, an interleukin-23 p19 inhibitor, has demonstrated efficacy in treating moderate-to-severe plaque psoriasis both in clinical trials and real-world setting. However, limited data are available on the impact of the effective treatment of psoriasis on the psychological health of patients. The aim of this study was to assess changes in psychological well-being, as well as clinical and quality-of-life outcomes, in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in routine clinical practice in Italy. This was an interim analysis (IA) of a 52-week multicenter, prospective, observational study. Adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled. Endpoints focused on well-being and psychological health and included changes, from baseline to week 28, in Depression, Anxiety, and Stress Scale-21 (DASS-21) scores, Dermatology Life Quality Index (DLQI), European Social Survey (ESS) items, and World Health Organization-Five Well-Being Index (WHO-5). Effectiveness was also monitored via Psoriasis Area and Severity Index (PASI), and safety via treatment-emergent adverse event reporting. A total of 115 patients were included (mean age 52.5 years, 60.8
BACKGROUND:Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder that markedly impairs quality of life. Dupilumab, an interleukin-4Rα antagonist, is approved for moderate-to-severe PN, but long-term real-world evidence remains limited. OBJECTIVES:To evaluate the long-term effectiveness and safety of dupilumab in adults with PN, including those with multiple comorbidities, in a real-world multicentre setting. METHODS:Clinical data were collected from 26 Italian dermatology centres [the Dupilumab Italian Prurigo Nodularis (DUPItaPN) study]. Adults with PN refractory to topical therapies and/or phototherapy, and/or prior systemic treatments who received dupilumab for a minimum treatment duration of 12 weeks were included. Outcomes routinely assessed in practice - Worst Itch (WI) Numeric Rating Scale (NRS) (WI-NRS), Investigator Global Assessment for PN-Stage (IGA PN-S), Sleep-NRS, Skin Pain-NRS and Dermatology Life Quality Index (DLQI) - were analysed at baseline and weeks 12, 24, 52, 76 and 104. Main endpoints were ≥ 4-point WI-NRS reduction and IGA PN-S 0/1 status. Predictors of response and safety were also evaluated. RESULTS:In total, 543 patients [mean age 65.7 (SD 15.8) years; 63.7% (346/543) female] were included. Dupilumab induced rapid and sustained improvements: mean WI-NRS decreased from 8.69 (SD 1.41) to 2.67 (SD 2.59) at week 24 and to 1.72 (SD 2.44) at week 104 (P < 0.001); ≥ 4-point WI-NRS reduction was achieved by 78.6% (408/519) and by 86.9% (258/297) of patients at 24 and 104 weeks, respectively; and IGA PN-S 0/1 achieved by 62.8% (326/519) and 81.1% (241/297) of patients at 24 and 104 weeks. DLQI improved from 17.40 (SD 6.94) to 2.57 (SD 4.89) (P < 0.001). Higher baseline WI-NRS predicted better outcomes, whereas psychiatric comorbidities and prior tricyclic antidepressant use predicted lower response. Dupilumab was well tolerated; discontinuation because of adverse events occurred in 2.9% (16/543), with no cancer progression or viral reactivation. CONCLUSIONS:Dupilumab provided sustained, clinically meaningful benefits and a favourable safety profile over 104 weeks, supporting its role as a long-term treatment for moderate-to-severe PN, including in older adults and patients with comorbidities.
Chronic plaque psoriasis significantly impairs physical, psychological, and social well-being. Patient-reported outcome measures (PROMs) are increasingly recognized as essential endpoints. Tildrakizumab, an interleukin (IL)-23p19 inhibitor, has demonstrated high efficacy and safety in clinical trials, but real-world data on its impact on PROMs remain limited. We aimed to evaluate the effect of tildrakizumab on psoriasis severity, symptoms, and health-related quality of life, including sleep disorders, and to assess correlations between severity of the disease (measured using the Psoriasis Area and Severity Index [PASI]) improvement and PROMs in a real-world cohort. Consecutive adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled and prospectively followed for 52 weeks. Assessments at baseline, week 16, and week 52 included the PASI; Dermatology Life Quality Index (DLQI); Skindex-16; Visual Analog Scale (VAS) for pruritus, scaling, and pain; the Medical Outcomes Study Sleep Scale (MOS-Sleep); and Work Productivity and Activity Impairment (WPAI) questionnaire. Thirty-three patients were enrolled in the study. Tildrakizumab induced rapid skin clearance and symptoms relief, with marked reductions in PASI and most PROMs by week 16. Pain and MOS-Sleep improved significantly only at Week 52. PASI correlated with PROMs at Week 16 (Spearman correlation), especially DLQI (r = 0.69, p < 0.001) and pruritus (r = 0.70, p < 0.001). At Week 52, correlations weakened for most PROMs, except Skindex-16 (r = 0.62, p < 0.01), pruritus (r = 0.54, p = 0.02), and scaling (r = 0.55, p = 0.02). Repeated-measures correlation analysis demonstrated significant within-subject associations between PASI improvement and most patient-reported outcomes (DLQI, scaling, pain, pruritus, and Skindex-16), while no significant associations were observed for WPAI and MOS-Sleep. Tildrakizumab improves both objective disease severity and quality of life at week 16. PASI strongly correlates with PROM improvements early in treatment, but correlations diminish over time, suggesting possible adaptation once skin clearance is sustained. PROMs should be integrated into long-term management to capture patient-centered benefits beyond skin clearance.
Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, has demonstrated efficacy and safety in phase III trials for moderate-to-severe atopic dermatitis (AD). However, long-term real-world evidence, particularly in European populations and in difficult-to-treat areas such as the head and neck, remains limited. This study evaluated the 52-week real-world effectiveness and safety of lebrikizumab in patients with moderate-to-severe AD. This retrospective, two-center study included adults and adolescents treated with lebrikizumab according to the approved label. Clinical assessments were performed at baseline and weeks 16, 24, and 52. Effectiveness outcomes included the Eczema Area and Severity Index (EASI) 75/90/100, absolute EASI thresholds, Investigator’s Global Assessment (IGA) 0/1, patient-reported outcomes (Peak Pruritus Numerical Rating Scale [PP-NRS] and Sleep Disturbance Numerical Rating Scale [S-NRS]), and minimal disease activity (MDA) defined as the combined endpoint EASI 90 plus PP-NRS 0/1. Head and neck involvement was specifically analyzed. Safety was assessed by recording adverse events (AEs). A total of 123 patients were included (116 adults, 7 adolescents). EASI 75 was achieved by 65.0
BACKGROUND:Isotretinoin is the most effective treatment for severe acne, but optimal cumulative dosing remains debated. While 120 mg/kg is standard, some advocate higher doses or prolonged treatment to reduce relapse. OBJECTIVES:To compare acne outcomes between 120 and 150 mg/kg cumulative isotretinoin dosing and to evaluate 12-month relapse and scarring. METHODS:In this single-centre, randomized single-blind trial, with blinded outcomes assessment, patients with moderate-to-severe cystic acne were allocated to cumulative isotretinoin doses of 120 or 150 mg/kg. Primary outcomes were changes in total lesion count and acne severity grade (1-8 scale) from baseline to mid-treatment and end of treatment; secondary outcomes included 12-month acne relapse and scarring. RESULTS:Both cumulative dose groups showed comparable improvements in acne severity and lesion counts from baseline to treatment completion, with no significant differences between groups (all p > 0.20). Scarring did not worsen over the course of treatment. At 12 months after treatment discontinuation, relapse rates were similar between groups: 26.7% in the 120 mg/kg group and 32.3% in the 150 mg/kg group (p = 0.619). Adverse events were mild and comparable. LIMITATIONS:Single-centre design and retrospective trial registration. CONCLUSIONS:Increasing dosing to 150 mg/kg provides no benefit. Extended therapy does not reduce relapse, supporting 120 mg/kg as optimal. Persistent acne required longer treatment.