Immunology Today — October 29, 2025

LucidQuest

1 week ago

This week’s immunology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

In Today’s Newsletter

💠 Novartis spotlights ACR immunology slate, incl. ianalumab late-breakers and SLE CAR-T biomarkers [1] [Switzerland • 25 Oct 2025]

https://www.novartis.com/news/media-releases/novartis-showcases-significant-immunology-advancements-acr-congress-new-data-complex-autoimmune-diseases
Context: 27 abstracts at ACR, incl. NEPTUNUS-1/2 Phase 3 (ianalumab, Sjögren’s) and rapcabtagene autoleucel biomarker data in refractory SLE.
Key point: Novartis says ianalumab Phase 3 results are late-breaking, and CAR-T biomarker readouts aim at immune reset.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Cosentyx hits primary and all secondary endpoints in PMR Phase 3 REPLENISH [2] [Switzerland • 22 Oct 2025]

https://www.novartis.com/news/media-releases/novartis-cosentyx-meets-primary-and-all-secondary-endpoints-phase-iii-trial-patients-polymyalgia-rheumatica-pmr
Context: Adults with PMR, Week 52 sustained remission; reduced steroid exposure; safety consistent.
Key point: Statistically significant remission vs placebo at Week 52, all secondary endpoints met (details to be presented).
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 BMS CD19 NEX-T CAR T shows encouraging Phase 1 signals in SSc, SLE, and IIM (Breakfree-1) [3] [US • 27 Oct 2025]

https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Encouraging-Data-from-Phase-1-Breakfree-1-Study-of-CD19-NEX-T-CAR-T-Cell-Therapy-in-Three-Chronic-Autoimmune-Diseases-at-ACR-Convergence-2025/default.aspx
Context: 71 treated; robust CAR-T expansion, B-cell depletion; low-grade CRS common, limited transient ICANS.
Key point: 94% of evaluable patients off chronic immunosuppression at analysis, plus cohort-specific functional gains (e.g., pFVC in SSc ILD).
Implication: May influence prescriber choice and payer reviews pending full data.

📈 Sotyktu late-breaking data in PsA and SLE underscore 52-week efficacy and safety [4] [US • 27 Oct 2025]

https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx
Context: POETYK PsA-1 Week 52 maintained responses; PAISLEY-SLE + LTE showed durable efficacy up to 4 years.
Key point: Radiographic non-progression and PRO gains in PsA; SLE responses sustained with consistent safety.
Implication: May influence prescriber choice and payer reviews pending full data.

🌌 Tremfya delivers 96-week durability in Crohn’s across GRAVITI and GALAXI [5] [US • 27 Oct 2025]

https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-the-first-and-only-il-23-inhibitor-with-a-fully-subcutaneous-treatment-regimen-demonstrates-durable-remission-in-crohns-disease-at-two-years
Context: LTE results to Week 96 after SC or IV induction, SC maintenance 100 mg q8w or 200 mg q4w.
Key point: High clinical remission rates at Week 96 with supportive endoscopic endpoints; safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.

🟠 Icotrokinra oral IL-23R blocker shows Week 28 UC benefits in ANTHEM-UC [6] [US • 27 Oct 2025]

https://www.jnj.com/media-center/press-releases/icotrokinra-maintains-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill-through-28-weeks-in-ulcerative-colitis
Context: Phase 2b UC; all doses outperformed placebo on clinical response, remission, endoscopic improvement, HEMI.
Key point: 400 mg QD achieved 31.7% clinical remission and 38.1% endoscopic improvement at Week 28; safety similar to placebo.
Implication: May influence prescriber choice and payer reviews pending full data.

✴️ Icotrokinra shows durable 52-week clearance at high-impact psoriasis sites (ICONIC-TOTAL) [7] [US • 24 Oct 2025]

https://www.jnj.com/media-center/press-releases/icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasis
Context: Adults and adolescents, scalp/genital/hand-foot PsO.
Key point: Site-specific clear/almost clear at Week 52: scalp 72%, genital 85%; overall IGA 0/1 at 52 weeks 67%, safety favorable.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Nipocalimab meets Phase 2 primary endpoint in Sjögren’s, published in The Lancet [8] [US • 24 Oct 2025]

https://www.jnj.com/media-center/press-releases/published-in-the-lancet-nipocalimab-significantly-decreased-sjogrens-disease-sjd-activity-and-severity-through-substantial-reduction-in-sjogrens-related-autoantibodies
Context: DAHLIAS Phase 2, moderate-to-severe SjD; FcRn blocker; BTD and Fast Track.
Key point: ClinESSDAI improvement at Week 24 vs placebo, biomarker reductions, preserved immune function, tolerable safety.
Implication: May influence prescriber choice and payer reviews pending full data.

🖐️ LEO Pharma quantifies U.S. chronic hand eczema prevalence in CHECK survey [9] [US • 27 Oct 2025]

https://www.biospace.com/press-releases/leo-pharma-unveils-data-on-the-u-s-prevalence-of-chronic-hand-eczema-at-fall-clinical-dermatology-conference
Context: Cross-sectional survey >10,000 adults.
Key point: 9.6% self-reported physician-diagnosed CHE, 65.1% moderate-to-severe; significant work and cost impacts reported.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧲 Biogen licenses Vanqua’s preclinical C5aR1 antagonist, up to $1B in milestones [10] [24 Oct 2025]

https://www.fiercebiotech.com/biotech/biogen-beefs-immunology-pipeline-1b-deal-vanquas-pre-clinical-c5ar1-antagonist
Context: $70M upfront, up to $990M milestones; target tied to neutrophil-mediated inflammation.
Key point: Program aims for clinic in 2027, complements Biogen’s izastobart and broader immunology push.
Implication: Signals pipeline investment and modality expansion.

🚻 Omvoh improves UC bowel-urgency severity, frequency, and deferral time (LUCENT-URGE) [11] [US • 27 Oct 2025]

https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained
Context: Phase 3b, single-arm, open-label; urgency-focused endpoints to Week 28.
Key point: 55% reduction in daily urgency by Week 12; severity down ~52% by Week 28; ≥15-min deferral rose from 4% to ~30%.
Implication: May influence prescriber choice and payer reviews pending full data.

🧴 EBGLYSS supports Q8W maintenance dosing with durable control in atopic dermatitis [12] [US • 24 Oct 2025]

https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-delivered-durable-disease
Context: ADjoin extension; IL-13 inhibitor; FDA label-update submission made.
Key point: ~80% achieved/maintained EASI-75 on Q8W dosing, comparable to Q4W; no new safety or immunogenicity signals.
Implication: May influence prescriber choice and payer reviews pending full data.

🧑‍🦲 Baricitinib shows strong 1-year adolescent AA outcomes in BRAVE-AA-PEDS [13] [US • 24 Oct 2025]

https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth
Context: Largest Phase 3 in adolescent severe AA; once-daily oral JAK inhibitor.
Key point: At 1 year, 54.1% (4 mg) achieved SALT ≤20; near-complete regrowth SALT ≤10 in 41.2%; safety consistent, no new signals.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it Matters

Late-breaking ACR/ACG reads tilt toward targeted pathways, oral options, and durability across IBD, PsA, SLE, and psoriasis.
CAR-T in autoimmunity continues to show immune-reset potential across multiple severe diseases.
Oral IL-23 axis agents, including receptor antagonism, are advancing in UC and psoriasis with favorable early safety.
Real-world and epidemiologic data illuminate disease burden that may shape coverage and care pathways.
Maintenance-sparing dosing and symptom-focused endpoints reflect growing emphasis on patient experience.

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FAQ

What did Novartis report for ianalumab in Sjögren’s?

Late-breaking Phase 3 NEPTUNUS-1/2 topline will be presented at ACR; specifics not disclosed in the release. Novartis positions ianalumab as a potential first targeted Sjögren’s therapy [1].

How far along is Cosentyx in PMR?

REPLENISH met its primary and all secondary endpoints at Week 52 with steroid-sparing signals; data will be presented and filed H1 2026, per Novartis [2].

What stands out in BMS’s Breakfree-1 CAR-T data?

Across SSc, SLE, and IIM, 94% of evaluable patients were off chronic immunosuppression at analysis with acceptable safety, plus functional gains such as pFVC improvement in SSc-ILD (n values limited) [3].

Are Sotyktu’s PsA benefits durable?

Yes, Week 52 POETYK PsA-1 data show maintained responses and inhibition of structural progression, with consistent safety. SLE Phase 2/LTE showed multi-year durability [4].

How durable is Tremfya in Crohn’s?

At Week 96, high clinical remission and supportive endoscopic outcomes were observed across dosing regimens, with safety consistent with the known profile [5].

What is icotrokinra showing across indications?

In UC, Week 28 Phase 2b showed higher clinical and endoscopic outcomes vs placebo across doses; in psoriasis, 52-week data demonstrated durable high-impact site clearance with favorable safety [6][7].

Entities / Keywords

Novartis; ianalumab (NEPTUNUS-1/2); rapcabtagene autoleucel/YTB323; Cosentyx/secukinumab; Bristol Myers Squibb; CD19 NEX-T CAR T (BMS-986353/CC-97540); Sotyktu/deucravacitinib (TYK2); Johnson & Johnson; Tremfya/guselkumab (IL-23, CD64 binding); icotrokinra (oral IL-23R blocker); nipocalimab/IMAAVY (FcRn); LEO Pharma; chronic hand eczema (CHECK); Biogen; Vanqua Bio; C5aR1 antagonist; Eli Lilly; Omvoh/mirikizumab; EBGLYSS/lebrikizumab; baricitinib/Olumiant; UC; Crohn’s; PsA; SLE; SSc; IIM; psoriasis; alopecia areata.