⚡BP Breakthrough, Oral IL-23 Inhibitor, and AAD 2025

Good morning. It's Saturday, Mar. 15, and we're covering a new oral IL-23 inhibitor for psoriasis, dupilumab’s breakthrough in bullous pemphigoid, key updates from AAD 2025, and more.

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Need To Know

Oral IL-23 Inhibitor Takes on Biologics in Psoriasis

At AAD 2025, Johnson & Johnson presented positive results from its ICONIC Phase 3 clinical program, a series of studies evaluating icotrokinra in moderate to severe psoriasis. Icotrokinra is a first-in-class oral peptide that selectively blocks the IL-23 receptor.

In the Phase 3 ICONIC-LEAD trial of 684 patients, 65% of icotrokinra-treated patients achieved clear or almost clear skin (IGA 0/1) by Week 16, compared to only 8% of placebo-treated patients. By Week 24, outcomes improved further: 74% of icotrokinra-treated patients had clear or almost clear skin, while 65% experienced at least a 90% reduction in psoriasis severity (PASI 90). Adverse events occurred at similar rates in both the icotrokinra and placebo groups.

Investigators also presented topline results from the ICONIC-ADVANCE 1 & 2 trials, which demonstrated icotrokinra’s superiority over the oral tyrosine kinase 2 (TYK2) inhibitor deucravacitinib at Weeks 16 and 24 for all endpoints.

Encouraged by these results, Johnson & Johnson launched ICONIC-ASCEND—the first trial seeking to demonstrate the superiority of an oral agent (icotrokinra) over an injectable biologic (ustekinumab) for psoriasis.

Dupilumab Nears Approval for Bullous Pemphigoid

Sanofi and Regeneron’s dupilumab (Dupixent) met all primary and key secondary endpoints in the ADEPT Phase 2/3 trial for moderate-to-severe bullous pemphigoid, according to late-breaking results presented at AAD 2025.

Investigators randomized 106 adults with bullous pemphigoid to receive either dupilumab alongside oral corticosteroids or oral corticosteroids alone. Patients tapered corticosteroids if their disease remained controlled.

By week 36, 20% of patients in the dupilumab group achieved sustained disease remission, compared to only 4% in the control group. Sustained remission was defined as achieving full clinical remission, completing corticosteroid taper by Week 16, and experiencing no relapse or rescue therapies by Week 36.

Notably, 40% of patients in the dupilumab group experienced at least a 90% reduction in disease severity, compared to 10% in the control group. Compared to the control group, the dupilumab group had a 54% lower risk of needing rescue medication and a 1678 mg lower cumulative corticosteroid dose on average.

Overall adverse events were similar between both groups, although dupilumab users reported slightly more asthma, conjunctivitis, and blurred vision.

In February the FDA accepted Sanofi and Regeneron’s supplemental application for dupilumab to treat bullous pemphigoid. A decision is expected by June 2025. If successful, the drug will become the first biologic approved for bullous pemphigoid.

Quick Hits

> Baricitinib’s Breakthrough in Severe Adolescent Alopecia Areata: Eli Lilly's JAK inhibitor baricitinib (Olumiant) demonstrated strong hair regrowth in adolescents with severe alopecia areata, according to late-breaking BRAVE-AA-PEDS Phase 3 trial data. At baseline, patients had an average of 89% scalp hair loss (near total alopecia), with 65% having minimal or no eyebrow hair and 57% having minimal or no eyelash hair. By week 36, 42% of those on baricitinib 4 mg achieved at least 80% scalp hair coverage (SALT score ≤20), compared to 5% of those on placebo. Notably, 50% of patients on baricitinib experienced significant eyebrow regrowth and 43% saw significant eyelash regrowth. Baricitinib’s safety profile mirrored its performance in trials for juvenile idiopathic arthritis and atopic dermatitis.

> A Next-Generation TYK2 for Psoriasis: Alumis Inc. presented promising data from the open-label extension of its Phase 2 STRIDE trial. The study evaluated ESK-001 in 80 patients with moderate-to-severe plaque psoriasis. ESK-001 is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor designed for maximal inhibition with minimal off-target effects. At 52 weeks, 61% of patients receiving 40 mg twice daily had at least a 90% reduction in psoriasis severity (PASI 90), while 39% achieved clear skin (PASI 100). With a favorable safety profile at one year, ESK-001 strengthens its trajectory toward becoming a best-in-class oral therapy for psoriasis. The drug is currently under evaluation in ongoing Phase 3 trials, with topline results anticipated by early 2026. 

> Rocatinlimab Hits Phase 3 Targets in Atopic Dermatitis: Rocatinlimab, developed by Kyowa Kirin and Amgen, met all primary and secondary endpoints in the Phase 3 IGNITE trial of 769 adults with moderate to severe atopic dermatitis. At week 24, 42% of patients on the higher dose of rocatinlimab achieved at least a 75% reduction in eczema severity (EASI 75) compared to 13% of those on placebo. The most common treatment-emergent adverse events were pyrexia, chills, and headache. In the separate SHUTTLE trial, which evaluated rocatinlimab combined with topical therapy, 52% of patients achieved EASI 75. Rocatinlimab, a human monoclonal antibody, is the first and only T-cell rebalancing therapy targeting OX40 to inhibit and reduce pathogenic T cells. Watch a quick breakdown of OX40/OX40L’s role in atopic dermatitis here.

> Tapinarof Enables Extended Treatment-Free Intervals In Eczema: A new analysis from Organon’s Phase 3 ADORING 3 long-term study supports the ability of tapinarof (Vtama) cream to enable treatment-free intervals in adults and children with atopic dermatitis who achieve initial disease clearance. Patients who reached clear skin with tapinarof cream stopped treatment and were monitored until disease activity returned to mild or greater severity, at which point they could restart treatment. On average, patients remained treatment-free for nearly 80 days, with disease severity still mild at the end of this period (mean EASI score: 3.4). The findings highlight tapinarof’s durability post-discontinuation. Watch how tapinarof works here.

> Ruxolitinib’s Mixed Results for Prurigo Nodularis: Incyte announced full results from its Phase 3 TRuE-PN1 trial evaluating ruxolitinib cream (Opzelura) in patients with prurigo nodularis. At 12 weeks, 45% of ruxolitinib-treated patients achieved a meaningful reduction in itch severity, compared to 21% of those using vehicle. Additionally, significantly more ruxolitinib-treated patients achieved clear or almost clear skin lesions compared to those using vehicle (16% vs. 4%). However, the companion Phase 3 TRuE-PN2 trial did not meet statistical significance for its primary endpoint. Ruxolitinib cream selectively targets JAK1 and JAK2 signaling pathways.

> Bimiralisib’s Promising Actinic Keratosis Data: Torqur AG announced interim results from its Phase 2 trial of once daily bimiralisib gel 2% for actinic keratosis. Among 35 patients who completed the initial treatment and follow-up visit, 70% in the four-week treatment group and 50% in the 2-week treatment group achieved either complete or partial clearance of their lesions. Treatment-related adverse events were mild and resolved quickly. Bimiralisib targets the overactive phosphoinositide 3-kinase (PI3K)/mechanistic target of rapamycin (mTOR) pathway, which plays a crucial role in actinic keratosis development. 

> Roflumilast in Difficult-to-Treat Atopic Dermatitis: Arcutis announced a post-hoc analysis of the INTEGUMENT 1-2 trials. Investigators evaluated roflumilast cream (Zoryve) in patients with mild to moderate atopic dermatitis who had an inadequate response, intolerance, or contraindication to either topical corticosteroids, calcineurin inhibitors, or crisaborole. Over the four-week trial, 91% of patients reported no or mild sensation at the application site, and investigators observed no irritation or minimal erythema in ≥97% of participants. Earlier this year, Arcutis stated that roflumilast is now the most prescribed branded non-steroidal topical therapy across three major inflammatory skin conditions in the United States. 

> Lebrikizumab’s Strong Three-Year Results: Eli Lilly presented three-year results from its ADjoin long-term extension trial of lebrikizumab (EBGLYSS). Findings showed that the interleukin-13 inhibitor provided deep and sustained skin clearance in moderate to severe atopic dermatitis. Among patients from the ADvocate 1 and 2 trials who responded at Week 16, 87% achieved a 90% reduction in eczema severity (EASI 90), while 50% attained complete skin clearance (EASI 100 or IGA 0) at three years. These results were achieved with a single monthly maintenance injection. No new safety concerns emerged during the study period.

> Deucravacitinib’s Durability in Psoriasis: Bristol Myers Squibb announced 5-year results from its POETYK PSO long-term extension trial of deucravacitinib (Sotyktu), a first-in-class oral tyrosine kinase 2 (TYK2) inhibitor, for adults with moderate to severe plaque psoriasis. Patients continuously treated with deucravacitinib maintained clinical efficacy over five years, with PASI 75 response rates—indicating at least a 75% reduction in psoriasis severity—of 72% at Year 1 and 67% at Year 5. The study showed consistent safety with no new safety signals.

> Bemikizumab Reduces Draining Tunnels in Hidradenitis Suppurativa: UCB released two-year results from the BE HEARD trials evaluating bimekizumab (Bimlex) for hidradenitis suppurativa. Among the 425 patients with at least one draining tunnel at baseline, 56% had none after two years of treatment. Skin pain also improved significantly, with 64% of patients reporting no or mild skin pain, up from 10% at baseline. Bimekizumab demonstrated sustained clinical benefits over two years, and no new safety concerns were identified during the study period. Bimekizumab is the first and only approved treatment that selectively inhibits both IL-17A and IL-17F.

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