A post hoc analysis of the ARCADIA long-term extension (LTE) programme revealed that the majority of patients who had already responded to nemolizumab maintained both itch relief and skin improvements through 104 weeks of continued therapy [1]. These findings highlight the durability of interleukin-31 (IL-31) receptor blockade as a long-term maintenance strategy in moderate-to-severe atopic dermatitis (AD).
Nemolizumab targets the IL-31 receptor, interrupting a neuroimmune signalling pathway implicated in pruritus, skin barrier dysfunction, and inflammation. Previously, the pivotal ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials demonstrated rapid and clinically meaningful improvements in both itch and skin manifestations of AD [2]. The current analysis evaluated the long-term durability of these responses.
The ARCADIA LTE (NCT03989206) was a prospective, multicentre, open-label extension programme that enrolled patients aged ≥12 years with moderate-to-severe AD from 7 phase 2/3 studies, as well as newly recruited adolescents. Participants received nemolizumab 30 mg every 4 weeks alongside low- or medium-potency topical corticosteroids, with or without topical calcineurin inhibitors. At the July 2024 data cut-off, 1,901 of 1,903 enrolled patients had received treatment, and 1,062 (55.9%) had completed 104 weeks of follow-up. Responders at LTE baseline were categorised according to the following criteria: a ≥4-point improvement in SCORing Atopic Dermatitis (SCORAD) VAS-itch score (n=618), a near itch-free state defined as SCORAD VAS-itch <2 (n=383), clear or almost clear skin according to the Investigator´s Global Assessment (IGA 0/1 (n=315)), Eczema Area and severity Index (EASI-75; n=441), and EASI-90 (n=291). The proportion of patients maintaining each response through week 104 was assessed using an observed-cases analysis.
Responses were highly durable over the 2-year treatment period. At week 104, 95.2% of patients maintained a ≥4-point itch improvement in itch score, while 89.6% remained itch-free or nearly itch-free. Skin responses were similarly sustained, with 96.6% and 92.3% of patients maintaining EASI-75 and EASI-90 responses, respectively, and 86.5% retaining an IGA score of 0/1. The long-term safety profile was consistent with that observed in the pivotal phase 3 studies. Treatment was well tolerated; the most frequently reported treatment-emergent adverse events were infections and respiratory disorders, and no deaths were reported.
Overall, these data support nemolizumab as an effective long-term maintenance treatment for patients with moderate-to-severe AD, providing sustained improvements in both itch and skin disease over 104 weeks.
- Thaçi D, et al. Long-term (up to 104 weeks) maintenance of itch and skin responses with nemolizumab treatment in patients with moderate-to-severe atopic dermatitis – post hoc analyses from the ARCADIA long-term extension trial. Abstract 76623, American Academy of Dermatology Annual Meeting 2026, 27–31 March 2026, Denver, Colorado, USA.
- Silverberg JI, et al. Lancet 2024;404 (10451):445-60.
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Children receiving weight-based nemolizumab achieved rapid improvements in eczema severity and itch. The safety assessment revealed no new safety signals.
The interleukin-31 receptor (IL-31RA) alpha antagonist nemolizumab was evaluated in a 52-week phase 2 study (NCT04921345) that included 109 children aged 2–11 years with moderate-to-severe atopic dermatitis (AD). The open-label trial comprised 3 consecutively enrolled cohorts. Primary outcomes focused on pharmacokinetics, including serum concentrations, clearance, and half-life, as well as safety; efficacy endpoints were also assessed [1].
Results from the first cohort (n=36) indicated pharmacokinetic differences relative to previous studies in adolescents and adults, prompting dose adjustments in the subsequent 2 cohorts. These cohorts were stratified by age (2–6 and 7–11 years) and received weight-based subcutaneous nemolizumab every 4 weeks for 52 weeks: 5 mg for children weighing 10 to <20 kg, 10 mg for 20 to <30 kg, and 15 mg for ≥30 kg. Concomitant use of topical corticosteroids and emollients was permitted.
At week 16, Investigator’s Global Assessment (IGA) scores of clear or almost clear (0/1) were achieved by 41% of children aged 7–11 years and 47% of those aged 2–6 years. Eczema Area and Severity Index (EASI): 75 responses were observed as early as week 4, reaching 73% and 69% at week 16, respectively. A clinically meaningful reduction in itch (≥4-point improvement on the Peak Pruritus Numerical Rating Scale [PP-NRS]) was reported by 59% of children aged 7–11 years and 72% of those aged 2–6 years at the same time point. Overall, treatment responses were sustained through week 52.
Safety findings were consistent with previous studies, with no new signals in this paediatric population. No serious adverse events were reported; however, 1 severe case of eosinophilia and 1 case of AD exacerbation occurred, both of which resolved.
- Eichenfield LF, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. S023 Late-Breaking Research: Session 1. AAD 2026, 27–31 March, Denver, CO, USA.
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Infants treated with topical roflumilast experienced meaningful improvements across multiple efficacy endpoints. The treatment was well tolerated and associated with a low discontinuation rate.
The phase 2 open-label INTEGUMENT-INFANT study (NCT06998056) evaluated once-daily roflumilast cream 0.05% in 101 paediatric patients aged 3 months to <24 months with atopic dermatitis (AD) [1]. Prof. Lawrence Eichenfield (UC San Diego School of Medicine, CA, USA) presented safety and efficacy data of the phosphodiesterase-4 (PDE-4) inhibitor roflumilast over 4 weeks in infants with moderate-to-severe AD.
Efficacy analyses in the 96 infants who completed the study showed that 34.4% achieved a ≥2-point improvement and reached clear or almost clear skin on the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) at week 4. Overall, 49% of patients achieved a vIGA-AD score of 0/1. Notably, approximately one-quarter of patients responded as early as week 2. Eczema Area and Severity Index (EASI) 75 responses were observed in 34% of patients at week 2 and increased to 58.3% by week 4.
Clinically meaningful responses were also observed in difficult-to-treat areas. Among infants with at least mild scalp involvement at baseline, 67.5% achieved clear or almost clear scalp skin at week 4.
Improvements in pruritus were rapid and substantial. By week 2, 60.3% of caregivers reported a ≥4-point reduction on the Worst Scratch Itch Numeric Rating Scale, increasing to 72.4% at week 4. Improvements measured by the Dynamic Pruritus Scale-25 were observed in nearly half of the infants within 10 minutes of application and in 66.7% at 4 hours.
Treatment-emergent adverse events were reported in 43.6% of patients, with nearly 36% classified as mild and none as severe. Adverse events (AEs) leading to discontinuation occurred in 1 patient, and no serious AEs were observed. The most common AEs (≥3%) were diarrhoea, nasopharyngitis, vomiting, and upper respiratory infections. Application-site irritation was reported in just over 2% of patients.
Based on these findings, roflumilast cream may represent a promising non-steroidal treatment option in the currently limited armamentarium for infants with AD.
- Eichenfield LF, et al. INTEGUMENT-INFANT: Once-daily roflumilast cream 0.05% in infants aged 3–<24 months with atopic dermatitis. S023 Late-Breaking Research: Session 1. AAD 2026, 27–31 March, Denver, CO, USA.
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The interleukin-17A/F (IL-17A/F)-targeting nanobody sonelokimab demonstrated high efficacy in patients with moderate-to-severe hidradenitis suppurativa (HS) over 40 weeks. Approximately 30% of patients achieved complete clearance across studies, accompanied by marked improvements in patient-reported disease burden.
Hidradenitis suppurativa (HS) remains one of the most therapeutically challenging conditions in dermatology, with a clear need for novel treatment options. Sonelokimab is a tri-specific nanobody that binds IL-17A and IL-17F and incorporates an anti-albumin moiety to prolong systemic exposure. As Prof. Alexa Kimball (Beth Israel Deaconess Medical Center, MA, USA) explained, the small molecular size of nanobodies may confer enhanced tissue penetration, favourable pharmacokinetics, and potentially improved safety compared with conventional monoclonal antibodies [1]. These properties previously translated into positive phase 2 results in HS, as well as in psoriasis and psoriatic arthritis [2].
The replicate phase 3 VELA-1 (NCT06411899) and VELA-2 (NCT06411379) trials randomised 838 adults with moderate-to-severe HS in a 2:1 ratio to sonelokimab or placebo. The primary endpoint, Hidradenitis Suppurativa Clinical Response by at least 75% (HiSCR75) at week 16, was achieved by approximately one-third of sonelokimab-treated patients, compared with 18%–25% in the placebo group. The current interim analysis extended follow-up to week 40 and included monthly maintenance dosing.
At week 40, 62% of patients achieved HiSCR75 across both trials, while 74%–79% reached HiSCR50. Deeper responses were also observed, with HiSCR90 achieved by 36%–40% of patients and complete clearance (HiSCR100) by approximately 30% of the pooled population. Lesion-specific analyses demonstrated reductions of 71–75% in inflammatory nodules, 72–79% in abscesses, and 60–69% in draining tunnels.
Patient-reported outcomes mirrored these clinical improvements. At baseline, 59% of patients were classified as having “very severe” disease according to the Hidradenitis Suppurativa Quality of Life (HiSQOL) measure; by week 40, 63% had improved to “mild or none.”
Tolerability remained favourable. Although the full 52-week safety data are pending, week 16 results showed serious treatment-emergent adverse events in 2.5% of sonelokimab-treated patients. The most common adverse events were nasopharyngitis (8.6%) and oral candidiasis (7.3%). Follow-up to week 52 is ongoing, alongside a long-term extension of the VELA programme and a separate trial in adolescents (12–17 years). Notably, up to 43% of patients experienced a marked reduction in pain.
With monthly dosing, biologic-comparable HiSCR100 rates of approximately 30%, and consistent improvements in quality of life, sonelokimab represents a promising option for the long-term management of moderate-to-severe HS.
- Kimball A. Sonelokimab in moderate-to-severe hidradenitis suppurativa: 40-week results from the phase III VELA-1 and VELA-2 trials. S034: Late-breaking Research Session 2. AAD 2026, 27–31 March, Denver, CO, USA.
- Sayed CJ, et al. J Am Acad Dermatol 2025;93(3) Suppl. AB2221.
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Week 54 data from the STOP-HS trial demonstrate sustained and increasing response rates with povorcitinib therapy. Improvements were observed across Hidradenitis Suppurativa Clinical Response (HiSCR), symptom burden, and quality-of-life measures.
In the pivotal STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836) trials, the Janus Kinase 1 (JAK1) inhibitor povorcitinib met the primary endpoint of HiSCR50 at week 12 in patients with hidradenitis suppurativa (HS). Given the chronic, relapsing nature of HS, long-term efficacy is a key consideration. Data up to week 54, presented by Dr Martina Porter (Beth Israel Deaconess Medical Center, MA, USA), provided further insight into sustained treatment effects [1].
The 2 studies enrolled 1,227 adult patients with Hurley stage 2 or 3 disease, corresponding to moderate-to-severe HS. Following the 12-week placebo-controlled phase, patients initially assigned to placebo switched to povorcitinib (75 mg or 45 mg once daily), while those already receiving povorcitinib continued their assigned dose during a 42-week extension period.
At baseline, the mean age was 37 years, 62.8% of participants were female, and 35.1% had Hurley stage 3 disease. Patient-reported outcomes included a mean Dermatology Life Quality Index (DLQI) score of 12.9 and a skin pain numerical rating scale (NRS) score of 5.0.
Long-term results showed continued increases in the proportion of patients achieving HiSCR50 through week 54. At week 12, HiSCR50 rates in STOP-HS1 were 40.6% (75 mg), 40.2% (45 mg), and 29.7% (placebo), and in STOP-HS2 were 42.3%, 42.3% and 28.6%, respectively. By week 54, these rates had increased to 61.9% (75 mg) and 60.2% (45 mg) among patients who continued povorcitinib in STOP-HS1, and to 68.1% and 68.3% among those who switched from placebo. Corresponding results in STOP-HS2 were 57.3% and 64.3% for continuous treatment, and 71.4% and 67.5% for those switching from placebo.
Depending on the dose and study group, higher response thresholds were also observed, with HiSCR90 rates ranging from 23.2% to 36.2% and HiSCR100 rates ranging from 17.9% to 29%. Reductions in abscesses, draining tunnels, and inflammatory nodules were sustained through week 54, with 16.1%–20.2% of patients achieving complete clearance of these lesion types.
Patient-reported outcomes showed clinically meaningful improvements, including a ≥3-point reduction in skin pain NRS (40.5%–46.8%) and a ≥4-point decrease in DLQI (59.4%–64.7%).
According to Dr Porter, both doses of povorcitinib were generally well-tolerated through 54 weeks of treatment, with safety data available for over 1,000 treated patients. The most common adverse events were acne, nasopharyngitis, and upper respiratory tract infections. Serious treatment-emergent adverse events (TEAEs) occurred in 3.7%–6.4% of patients. There was 1 fatal TEAE, 1 case of major adverse cardiovascular event, 8 thromboembolic events, and 23 cases of herpes zoster; no malignancies were reported.
- Porter ML, et al. Povorcitinib in patients with moderate to severe hidradenitis suppurativa: 54-week efficacy and safety results from the STOP-HS1 & STOP-HS2 phase 3 studies. S034 Late-Breaking Research: Session 2. AAD 2026, 27–31 March, Denver, CO, USA.
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The novel tyrosine kinase 2 (TYK2) inhibitor envudeucitinib (ESK-001) produced high levels of skin clearance with a reassuring tolerability profile in the phase 3 ONWARD 1 and 2 trials. By week 24, Psoriasis Area and Severity Index (PASI) 90 was achieved by approximately 65% of patients with moderate-to-severe plaque psoriasis, and complete clearance (PASI 100) by 40% of patients, approaching response levels typically associated with biologic therapy.
TYK2 inhibition has emerged as an attractive oral strategy in psoriasis, as it enables selective modulation of interleukin-23 (IL-23) and type I interferon signalling without broader inhibition of the Janus kinase (JAK) pathway, which is associated with known adverse effects. As Dr Andrew Blauvelt (University of Maryland School of Medicine, MD, USA) noted, envudeucitinib achieves sustained TYK2 inhibition throughout the 24-hour dosing interval. But does this translate into clinical benefit? This question was now answered by the ONWARD 1 (NCT06586112) and ONWARD 2 (NCT06588738) pivotal trials, presented in a late-breaking research session [1].
Both randomised, double-blind studies enrolled more than 1,700 adults with moderate-to-severe plaque psoriasis and compared envudeucitinib 40 mg twice daily with apremilast and placebo. Co-primary endpoints at week 16 were PASI 75 and a Physician’s Global Assessment (PGA) score of 0/1. Both trials met all primary and secondary endpoints, demonstrating clinically meaningful separation from comparators; approximately 75% of patients receiving envudeucitinib achieved PASI 75 at week 16, compared with substantially lower response rates in the apremilast and placebo groups. At the same time point, 59% of patients achieved PGA 0/1.
Response depth continued to increase through week 24, consistent with the delayed efficacy often observed with agents modulating the interleukin-23 (IL-23) pathway. At week 24, approximately 80% of patients achieved PASI 75, around 65% reached PASI 90, and 40% attained complete PASI 100. Envudeucitinib outperformed apremilast across all PASI endpoints at week 24 (P<0.0001). Dr Blauvelt emphasised the clinical relevance of achieving a 40% PASI 100 rate with an oral therapy, a level of efficacy historically associated with biologic agents.
The safety signal was favourable and consistent with prior experience with TYK2. The most frequently reported adverse events were nasopharyngitis and upper respiratory tract infections. No signals were observed for major adverse cardiovascular events, tuberculosis reactivation, or laboratory abnormalities, including lipid elevations.
Looking ahead, Dr Blauvelt suggested that the typical regulatory timeline for late-breaking phase 3 dermatology data may apply, with potential market entry within the following year. A long-release once-daily formulation is under development to replace the current 40 mg twice-daily regimen, and paediatric studies are planned.
With PASI 100 achieved in approximately 40% of patients at week 24 and no new safety concerns identified, envudeucitinib, described by Dr Blauvelt as a “next-generation or second-generation TYK2 inhibitor,” may expand the oral treatment landscape for moderate-to-severe plaque psoriasis, offering a biologic-like efficacy profile for patients who prefer oral therapy.
- Blauvelt A. Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomised, double-blind, active comparator- and placebo-controlled, phase 3 ONWARD 1 and 2 studies. AAD 2026, 27–31 March, Denver, CO, USA.
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In patients with psoriatic arthritis (PsA) and coexisting overweight or obesity, adding the glucagon-like peptide-1 (GLP-1) agonist tirzepatide to the interleukin-17A (IL-17A) inhibitor ixekizumab substantially improved both articular and metabolic outcomes. In a phase 3 randomised trial, nearly one-third of patients receiving the combination achieved a composite endpoint of the American College of Rheumatology 50% improvement criteria (ACR50) plus ≥10% weight loss at week 36, compared with fewer than 1% of patients receiving ixekizumab monotherapy.
Approximately half of adults with PsA are affected by obesity [1]. This burden is increasingly recognised as contributing to reduced response to biologic therapy [2], increasing cardiometabolic risk, and impaired patient-reported outcomes. Against this background, dual targeting of inflammatory disease activity and adiposity has emerged as a rational therapeutic strategy. This approach was evaluated in the phase 3b TOGETHER-PsA head-to-head trial (NCT06588296), presented by Prof. Joseph Merola (UT Southwestern Medical Center, TX, USA) [3].
Adults with PsA and overweight or obesity, along with at least 1 weight-related comorbidity (n=271), were randomised to receive ixekizumab plus tirzepatide or ixekizumab alone and were followed for 36 weeks. The primary composite endpoint required achievement of both ACR50 and ≥10% body-weight reduction. At week 36, this endpoint was met by 31.7% of patients in the combination arm, compared with fewer than 1% of the ixekizumab monotherapy arm.
Hierarchical secondary analyses supported the primary findings. The proportions of patients achieving ACR50 (33.5% vs 20.4%; P<0.05), ≥10% weight loss (84.5% vs 4.5%; P<0.001), or the alternative composite of ACR20 plus ≥5% weight reduction (69.7% vs. 10.3%; P<0.001) were all significantly higher with combination therapy. Additional articular outcomes and patient-reported measures, including overall symptom burden and quality of life, also consistently favoured the dual-therapy approach.
According to Prof. Merola, the early and statistically robust separation in ACR50 was particularly notable and may signal a potential paradigm shift. He further emphasised that effective management of obesity as a core comorbidity is likely to translate into long-term improvements in quality of life and potentially survival in this population.
For dermatologists managing PsA in patients with overweight or obesity, the combination of ixekizumab and tirzepatide may offer meaningful benefits for skin-joint disease activity and cardiometabolic health, supporting an integrated treatment approach.
- Siebert S, et al. Joint Bone Spine 2025;92(5):105904.
- Di Minno M, et al. Arthritis Care Res (Hoboken) 2013:65(1):141-147.
- Merola JF. Ixekizumab plus tirzepatide in patients with psoriatic arthritis and overweight or obesity: a phase III randomised trial. S034: Late-breaking Research Session 2. AAD 2026, 27–31 March, Denver, CO, USA.
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New analyses demonstrate that bimekizumab maintains high rates of clinical response across the skin, joints, and nails, irrespective of prior biologic exposure. Biologic-naïve patients with psoriatic arthritis (PsA), for example, achieved long-term response maintenance rates exceeding 80% in observed cases.
Sustained response following complete clinical resolution is an important treatment goal in PsA [1]. A post-hoc analysis of the phase 3 BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials evaluated the durability of bimekizumab responses across skin, joint, and nail domains up to weeks 160 and 156, respectively. Completion rates at these timepoints exceeded 75% in both studies. The trials included biologic-naïve adults with PsA as well as patients with prior inadequate response to tumour necrosis factor (TNF) inhibitors.
Complete clinical resolution was defined as achieving Psoriasis Area and Severity Index (PASI) 100 or a swollen joint count (SJC) of 0 at week 16, or modified Nail Psoriasis Severity Index (mNAPSI) of 0 at weeks 24 or 28. Maintenance of ≥50% improvement per the American College of Rheumatology (ACR50) criteria, achieved at week 16, was also assessed. Outcomes were analysed using modified non-responder imputation (mNRI) and observed cases (OC).
In BE OPTIMAL, just under half of the patients with ≥3% body surface area involvement at baseline achieved PASI 100. In BE COMPLETE (patients with prior TNF inhibitors inadequate response), PASI 100 rates were 58.7% (mNRI) and 59.9% (OC). At 3 years, PASI 100 responses were sustained in 82.1% (OC) and 66.0% (mNRI) of biologic-naïve patients, and in 92.0% (OC) and 81.5% (mNRI) of pre-treated patients. Corresponding maintenance rates for mNAPSI=0 were 88.0% and 74.6% in BE OPTIMAL, and 91.0% and 80.7% in BE COMPLETE.
For joint outcomes, SJC=0 responses were maintained by 84.3% (OC) and 69.8% (mNRI) of week 16 responders in biologic-naïve patients. In BE COMPLETE, corresponding maintenance rates were 92.7% (OC) and 77.9% (mNRI). ACR50 responses were similarly durable, with approximately 90% (OC) and 80% (mNRI) of initial responders maintaining improvement across both studies.
Prof. Joseph Merola (UT Southwestern Medical Center, TX, USA) and colleagues concluded that these findings support bimekizumab as an effective long-term treatment option for patients with PsA, demonstrating sustained, high-level efficacy regardless of prior biologic exposure.
- Merola JF, et al. Bimekizumab treatment resulted in long-term maintenance of complete clinical resolution across skin, joint, and nail domains in patients with active psoriatic arthritis: 3-year results from two phase 3 studies. Poster 73665. AAD 2026, 27–31 March, Denver, CO, USA.
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