This weekly Immunology newsletter features late-phase efficacy readouts, regional clinical guidance, early outpatient cell-therapy feasibility, EU approvals, M&A moves, and Phase 2 safety signals.
In Today’s Newsletter
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💊 TREMFYA inhibits PsA structural damage through 48 weeks [1] [US • 17 Nov 2025]
Context: Phase 3b APEX in active PsA, Q4W/Q8W dosing, vdH-S radiographic assessment, 48 weeks.
Key point: Significant Week 24 radiographic inhibition sustained to Week 48, ACR50 increased, no new safety signals.
Implication: May influence prescriber choice and payer reviews pending full data.
🧒 Systemic JIA guidance emphasizes IL-1/IL-6 first, less steroids [2] [14 Nov 2025]
Context: Latin American expert panel, evidence-based recommendations for systemic JIA phenotypes.
Key point: Early IL-1 or IL-6 inhibition preferred, short steroid courses with planned taper and escalation rules.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 AlloNK shows deep B-cell depletion in outpatient autoimmune cohorts [3] [12 Nov 2025]
Context: 32 patients across RA, Sjögren’s, SLE/LN, IIM, SSc; AlloNK + rituximab/obinutuzumab after Cy/Flu; community sites.
Key point: No CRS/ICANS, mostly Grade 1–2 AEs, non-quantifiable CD19+ cells by Day 13 in analyzed samples.
Implication: Signals pipeline investment and modality expansion.
🤝 Azurity buys Sebela’s bowel-prep franchise [4] [US • 17 Nov 2025]
Context: Strategic transaction adds colonoscopy bowel-prep brands and commercial team to Azurity GI portfolio.
Key point: Azurity expands in Gastroenterology, Sebela focuses on tegoprazan NDA for GERD.
Implication: Signals pipeline investment and modality expansion.
🧵 Ontunisertib Phase 2a hits safety primary in FS Crohn’s [5] [17 Nov 2025]
Context: STENOVA Part A, n=103, 12 weeks, randomized placebo-controlled; GI-restricted ALK5 inhibitor; OLE ongoing.
Key point: Safety comparable to placebo, PK confirms gut-restricted profile, positive trends on SES-CD and MRE.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 EC approves Remsima IV liquid infliximab formulation [6] [EU • 18 Nov 2025]
https://finance.yahoo.com/news/european-commission-grants-approval-remsima-072300087.html
Context: Celltrion’s liquid IV infliximab approved for all prior Remsima IV indications.
Key point: 100 mg and 350 mg vials remove reconstitution, with reported 51% prep-time and 20% prep-cost reductions.
Implication: Introduces competition that may affect pricing and formulary access.
👶 FDA accepts sNDA for roflumilast cream in ages 2–5 [7] [17 Nov 2025]
Context: Arcutis seeks to extend ZORYVE cream 0.3% to ages 2–5; PDUFA 29 Jun 2026.
Key point: Supported by pediatric MUSE and long-term open-label data showing acceptable exposure and safety.
Implication: May influence prescriber choice and payer reviews pending full data.
✋ Tralokinumab ADHAND 32-week topline remains positive [8] [17 Nov 2025]
Context: Phase 3b, adults with moderate-to-severe hand involvement in AD; 16-week DB then 16-week open-label.
Key point: Week 16 primary and key secondary endpoints met, Week 32 endpoints also positive, no new safety issues noted.
Implication: May influence prescriber choice and payer reviews pending full data.
🧑⚕️ Health Canada approves ZORYVE foam 0.3% for scalp/body psoriasis [9] [CA • 13 Nov 2025]
Context: Approval for patients 12+; data from Phase 3 ARRECTOR and Phase 2, total n=734 across studies.
Key point: Significant S-IGA and B-IGA success and itch improvements, generally well tolerated.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Biologics are differentiating on structural outcomes in PsA, a prescriber and payer priority.
- Operational advances, like liquid infliximab, can deliver workflow and budget gains beyond efficacy.
- Topical and systemic options are expanding across ages and hard-to-treat areas, supporting adherence.
- Early cytokine-pathway targeting with steroid minimization is shaping pediatric rheumatology standards.
- NK-cell strategies are moving into community autoimmune care, broadening delivery models.
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FAQ
What is new in TREMFYA’s PsA dataset?
J&J reports sustained radiographic progression inhibition to Week 48 in APEX, with increasing ACR50 and no new safety signals, supporting an sBLA for structural-damage language [1].
How do the systemic JIA recommendations guide therapy?
Experts favor early IL-1 or IL-6 inhibition for key phenotypes, with short, tapered glucocorticoids to minimize exposure and clear escalation strategies [2].
What did Artiva show with AlloNK in autoimmune disease?
Initial data indicate outpatient feasibility, no CRS/ICANS, and deep B-cell depletion by Day 13 across analyzed samples, with FDA discussions for an RA pivotal design planned in 1H 2026 [3].
What changed for infliximab in the EU?
Celltrion’s Remsima IV liquid is EC-approved for all infliximab indications, eliminating reconstitution and reporting shorter prep time and lower prep costs vs powder [6].
Which Arcutis programs moved forward?
FDA accepted the sNDA for ZORYVE cream 0.3% in ages 2–5 with a 29 Jun 2026 PDUFA date [7], and Health Canada approved ZORYVE foam 0.3% for scalp and body psoriasis in patients 12+ [9].
Entities / Keywords
TREMFYA, guselkumab, PsA; IL-23; APEX; vdH-S
Systemic JIA; IL-1, IL-6; glucocorticoid taper
AlloNK, AB-101; rituximab, obinutuzumab; B-cell depletion
Azurity, Sebela; bowel-prep franchise; tegoprazan
Agomab, ontunisertib, ALK5, TGF-β; FS Crohn’s; STENOVA
Celltrion, Remsima IV liquid, infliximab; EC approval
Arcutis, roflumilast cream 0.3%, pediatric psoriasis sNDA
LEO Pharma, tralokinumab, ADHAND
ZORYVE foam 0.3%, Health Canada, ARRECTOR
References
- https://www.jnj.com/media-center/press-releases/new-long-term-data-reinforces-tremfya-guselkumab-as-the-only-il-23-inhibitor-proven-to-substantially-inhibit-structural-joint-damage-in-active-psoriatic-arthritis
- https://www.emjreviews.com/rheumatology/news/updated-guidance-on-juvenile-idiopathic-arthritis-management/
- https://www.manilatimes.net/2025/11/12/tmt-newswire/globenewswire/artiva-biotherapeutics-announces-positive-initial-safety-and-translational-data-supporting-deep-b-cell-depletion-with-allonk-in-autoimmune-disease/2221919
- https://www.globenewswire.com/de/news-release/2025/11/17/3189156/0/en/Azurity-Pharmaceuticals-and-Sebela-Pharmaceuticals-Announce-the-Sale-of-Sebela-s-Bowel-Prep-Franchise-to-Azurity.html
- https://www.manilatimes.net/2025/11/17/tmt-newswire/globenewswire/agomab-announces-positive-topline-phase-2a-data-for-ontunisertib-in-fibrostenosing-crohns-disease/2225105
- https://finance.yahoo.com/news/european-commission-grants-approval-remsima-072300087.html
- https://www.dermatologytimes.com/view/roflumilast-snda-accepted-for-plaque-psoriasis-in-patients-2-to-5-years
- https://via.ritzau.dk/pressemeddelelse/14679407/leo-pharma-announces-positive-topline-32-week-key-results-in-adhand-trial?publisherId=12353927&lang=da
- https://www.newswire.ca/news-releases/arcutis-canada-announces-health-canada-approval-of-zoryve-r-foam-0-3-the-first-steroid-free-topical-foam-for-scalp-and-body-psoriasis-for-adults-and-adolescents-ages-12-and-older-804128088.html