Immunology Update: Bimekizumab Durability, Icotrokinra Win, Ritlecitinib AA Data, Tremfya UC Nod and More
From bimekizumab’s four-year durability and oral icotrokinra’s head-to-head win over Sotyktu to Tremfya’s subcutaneous induction approval in UC—this week’s signals are powerful. We span dermatology, immunology, real-world evidence, consumer skin health, and more, with regulatory milestones and pipeline advances across areas, underscoring long-term disease control and intensifying IL-23 class competition
In Today’s Newsletter
🧴 Bimekizumab 3–4y durability in psoriasis [1] [EU • 17 Sep 2025]
Context: Pooled Ph3 + OLE (BE VIVID/SURE/READY → BE BRIGHT/RADIANT); continuous BKZ cohorts.
Key point: 48.9% of week-16 PASI 0 responders sustained PASI 0 at every visit to year 4; nail mNAPSI 0 ~82% at year 3; low PsA symptoms maintained in high-risk subgroup.
Implication: May influence prescriber choice and payer reviews pending full data.
🧴 Ruxolitinib cream pooled Ph3 in PN hits endpoints [2] [EU • 18 Sep 2025]
Context: TRuE-PN1/2 (N=394); 12-week DB period + 40-week OLE.
Key point: Week-12 WI-NRS4: 42.3% vs 28.1%; IGA-CPG-S TS: 19.8% vs 7.1%; safety acceptable; responses sustained/align by week 24.
Implication: May influence prescriber choice and payer reviews pending full data.
😊 Tildrakizumab boosts WHO-5 and PASI in RWE POSITIVE [3] [EU • 18 Sep 2025]
Context: Multinational 24-month phase IV RWE (N=785) in routine care.
Key point: WHO-5 rose from 53.7 → 70.43 at 2y; PASI from 12.9 → 1.3 (79% PASI≤2); DLQI-R improved; tolerability consistent.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧪 Cetaphil “Skin Activator” line launch (AHA+CICA) [4] [17 Sep 2025]
Context: Consumer derm skincare; clinical and consumer data cited by brand.
Key point: New hydrating/firming products with microdosed mandelic acid + encapsulated CICA; early improvements in texture/“crepiness” reported.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🏙️ Sensitive skin RWE: urban living elevates inflammation [5] [CN • 17 Sep 2025]
Context: China study (N=150 women, 35–50); modern vs traditional environments; tape-strip biomarkers.
Key point: Modern-environment sensitive skin showed ~3x higher PGE2, elevated oxidative stress, more dark spots vs comparators.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Camoteskimab (anti-IL-18) hits in AD Ph2a [6] [16 Sep 2025]
https://www.fiercebiotech.com/biotech/apollos-15m-bet-il-18-antibody-pays-phase-2-eczema-win
Context: 62 pts, US/Canada; IV dosing; 16-week primary readout with open-label extension.
Key point: Met primary (EASI reduction vs placebo); open-label responses deepened (~80% mean EASI reduction; ~65% EASI-75), incl. prior anti-IL-13/IL-4 failures.
Implication: Signals pipeline investment and modality expansion.
👩🦲 Ritlecitinib 3-year durability in alopecia areata [7] [EU • 20 Sep 2025]
Context: ALLEGRO program; adults/adolescents; EADV presentation.
Key point: ~30% achieved SALT=0 by months 36–38; ~65% (obs.) and ~47% (LOCF) maintained SALT≤20; safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Oral icotrokinra beats Sotyktu head-to-head [8] [EU • 18 Sep 2025]
Context: ICONIC-ADVANCE 1/2 Ph3; oral IL-23 peptide vs deucravacitinib.
Key point: Week-16 IGA 0/1: 68–70% vs 50–54%; PASI90: 55–57% vs 30–34%; benefits increased at week 24; 52-week maintenance data supportive.
Implication: May influence prescriber choice and payer reviews pending full data.
🩺 GLP-1 RAs linked to lower risks in psoriasis (RWE) [9] [EU • 18 Sep 2025]
https://www.medscape.com/viewarticle/psoriasis-patients-could-benefit-glp-1-therapy-2025a1000ovf
Context: Retrospective TriNetX; matched cohorts with obesity/T2D + psoriasis.
Key point: GLP-1 RA use associated with 78% lower mortality, 44% lower MACE (incl. ↓HF 46%, ↓stroke 65%); psychiatric risk reductions noted; causality not established.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
✅ Tremfya SC induction approved in UC (US) [10] [US • 22 Sep 2025]
Context: FDA approval expands UC induction options; based on ASTRO trial.
Key point: SC induction achieved early symptomatic response; Week-12 remission 26% (400 mg) vs 7% placebo; now first IL-23 with both IV and SC from induction through maintenance across IBD.
Implication: Introduces competition that may affect pricing and formulary access.
🇪🇺 CHMP backs Tremfya SC induction in UC (EU) [11] [EU • 22 Sep 2025]
Context: Positive opinion for 400 mg SC at weeks 0/4/8; based on ASTRO.
Key point: Clinically meaningful improvements across endpoints vs placebo; safety aligned with known profile and GRAVITI CD data.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Oral options in psoriasis (icotrokinra) are challenging Sotyktu and may widen adherence-friendly choices.
- Durable efficacy signals (bimekizumab, ritlecitinib) support long-term disease control narratives.
- RWE is shaping holistic care (WHO-5 in POSITIVE; GLP-1 in psoriasis; urban sensitive-skin biology).
- Anti-IL-18 in AD offers a non-Th2 path for post-Dupixent-class patients.
- Tremfya’s SC induction could simplify IBD starts and intensify IL-23 class competition.
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FAQ
Q1. What sets icotrokinra apart from Sotyktu in psoriasis? [8]
Icotrokinra (oral IL-23 peptide; J&J/Protagonist) showed higher IGA 0/1 and PASI90 at weeks 16 and 24 vs deucravacitinib. Data were presented at EADV; an NDA is submitted for plaque psoriasis.
Q2. How durable is bimekizumab’s skin clearance? [1]
Among week-16 PASI 0 responders entering OLE, 48.9% maintained PASI 0 at every visit to 4 years, with strong nail outcomes at 3 years. These are OLE data from pooled Ph3 programs.
Q3. Is ruxolitinib cream near an FDA filing for prurigo nodularis? [2]
Pooled Ph3 met primary/secondary endpoints with maintained responses to 24 weeks and favorable safety, which “could set the stage” for filing; full data pending.
Q4. What’s new about Tremfya in UC? [10][11]
US FDA approved subcutaneous induction (and CHMP backed SC induction in EU), making Tremfya the first IL-23 with both IV and SC options from induction through maintenance in IBD.
Q5. Does GLP-1 therapy help psoriasis directly? [9]
Observational cohorts linked GLP-1 RAs to lower mortality, MACE, and certain psychiatric risks in psoriasis with obesity/T2D. Causality and psoriasis-specific skin effects remain uncertain; more evidence is needed.
Q6. Where might camoteskimab fit in AD? [6]
The anti-IL-18 mAb met its Ph2a primary endpoint and showed responses in patients who previously failed anti-IL-13/IL-4 biologics, suggesting a potential role beyond Th2-specific agents.
Entities / Keywords
Bimekizumab (BIMZELX; UCB); Ruxolitinib cream (Opzelura; Incyte); Tildrakizumab (Almirall; IL-23); Cetaphil Skin Activator (Galderma); Sensitive skin RWE (GSSF; Galderma); Camoteskimab (Apollo; anti-IL-18; Avalo); Ritlecitinib (Litfulo; Pfizer; JAK); Icotrokinra (J&J; Protagonist; oral IL-23 peptide); Sotyktu (Deucravacitinib; BMS); GLP-1 receptor agonists (class RWE); Tremfya (Guselkumab; J&J; IL-23).
References
https://www.fiercebiotech.com/biotech/apollos-15m-bet-il-18-antibody-pays-phase-2-eczema-win
https://www.medscape.com/viewarticle/psoriasis-patients-could-benefit-glp-1-therapy-2025a1000ovf