Immunology Video Recap—November 19, 2025

This biweekly immunology video brings you key highlights from across the immunology landscape, featuring late-stage readouts, regulatory milestones, access decisions, label updates, and lifecycle expansions across inflammatory and immune disorders.

🎯 Watch Our Video Summary Capturing Immunology News from the Last Two Weeks

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Week 5–11 November 2025
Week 12-18 November 2025

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Transcript

Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

In allergic fungal rhinosinusitis affecting patients ages 6 and older, dupilumab in the Phase 3 LIBERTY-AFRS-AIMS trial improved sinus opacification, nasal congestion, and polyp size versus placebo, and it was associated with a 92% lower risk of systemic steroids and/or surgery over 52 weeks; the FDA has accepted the supplemental biologics license application for priority review with a PDUFA date of 28 Feb 2026.

In the United Kingdom, delgocitinib cream is now recommended by NICE for adults with moderate to severe chronic hand eczema when topical steroids are inadequate or unsuitable, building on evidence from the DELTA program and real-world reinforcement.

In the United States, linaclotide is approved for irritable bowel syndrome with constipation in children 7 to 17 years, making it the first therapy for this population; the updated label recommends 145 µg once daily and indicates a safety profile similar to adults.

In hypereosinophilic syndrome, monthly subcutaneous benralizumab in the Phase 3 NATRON trial delayed time to first disease worsening or flare and met all key secondary outcomes, with safety consistent with the known profile.

In active psoriatic arthritis, the Phase 3b APEX study showed that guselkumab substantially inhibited structural joint damage by van der Heijde–Sharp at Week 24 and sustained this through Week 48, alongside rising ACR50 responses and no new safety signals; a supplemental biologics application has been submitted to incorporate the structural-damage evidence.

Across the European Union, the European Commission has approved Celltrion’s Remsima IV liquid infliximab in 100 mg and 350 mg vials for all prior powder-form indications, eliminating reconstitution and reportedly reducing preparation time by 51 percent and preparation costs by 20 percent, with projected savings up to €2.6 million across seven countries.

For pediatric dermatology, the FDA has accepted a supplemental application to extend roflumilast cream 0.3 percent to children 2 to 5 years for plaque psoriasis, supported by pediatric MUSE and long-term open-label data, with a PDUFA date of 29 Jun 2026; if approved, this would be the first topical PDE4 for this age group.

Finally, in atopic dermatitis with moderate to severe hand involvement, the Phase 3b ADHAND study of tralokinumab met its primary and key secondary endpoints at Week 16 and maintained positive topline results at Week 32, with no new safety signals reported. Stay ahead in Immunology research! Like, share, and subscribe for our updates. Visit www.lqventures.com
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Why it matters

Type 2 inflammation programs keep expanding into niche airway and sinus phenotypes with regulatory momentum.
Pediatric GI care now has a first-in-class IBS-C option, potentially shifting algorithms.
Operational biosimilar innovations in the EU can free infusion capacity and reduce costs.
Dermatology continues to broaden age ranges and hard-to-treat areas with targeted topicals and biologics.

🗓️ Explore weekly details and sources

Week 5–11 November 2025
Week 12-18 November 2025

📚 Find your one-stop page for the full Immunology archive.

FAQ

What is new about Dupixent in AFRS?

Phase 3 LIBERTY-AFRS-AIMS met all endpoints in ages 6+, with reported improvements in sinus CT, congestion, and polyp size, plus lower steroid/surgery risk; FDA priority review accepted with a 28 Feb 2026 target action date [1].

How does linaclotide’s pediatric approval change IBS-C care?

The FDA approved linaclotide for IBS-C in children 7+, the first therapy for this group, with a 145 µg once-daily dose and safety consistent with adults per the updated label and pediatric trial data [3].

What did NATRON show for FASENRA in HES?

Monthly benralizumab delayed time to first worsening/flare and met key secondaries including fewer flares and improved fatigue, with a familiar safety profile in this rare eosinophilic disease [4].

What differentiates the new Remsima IV liquid?

EC approval covers all infliximab indications, removing reconstitution and, per reported data, reducing preparation time by 51% and costs by 20%, with projected EU savings across seven countries [6].

Any notable dermatology updates?

TREMFYA showed sustained PsA structural-damage inhibition to Week 48 [5]; FDA accepted roflumilast cream sNDA for ages 2–5 [7]; tralokinumab ADHAND 32-week topline stayed positive in hand-involved AD [8].

Entities / Keywords

Dupixent, dupilumab; AFRS; LIBERTY-AFRS-AIMS; sBLA
Delgocitinib; chronic hand eczema; NICE
Linaclotide, LINZESS; IBS-C pediatric
FASENRA, benralizumab; HES; NATRON
TREMFYA, guselkumab; PsA; APEX; vdH-S
Remsima IV liquid; infliximab; EC approval
Roflumilast cream 0.3% (ZORYVE); pediatric psoriasis sNDA
Tralokinumab; ADHAND; atopic dermatitis hand involvement