Immunology Video Recap—December 3, 2025

This biweekly immunology video highlights major regulatory wins, evolving treatment guidelines, new scoring tools, early-stage pipeline activity, and strategic partnerships shaping future care.

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Week 19–25 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.

Sanofi’s Dupixent has been approved in the EU as the first targeted treatment for chronic spontaneous urticaria, or CSU, in over a decade. This approval is for patients aged 12 years and older who have not responded to antihistamines. Dupixent has shown significant improvements in reducing both itch and hives, offering a new first-line treatment for managing this chronic condition. This approval provides an important alternative for patients who previously had limited treatment options.

In other news, the American Gastroenterological Association has updated its guidelines for Crohn’s disease. The new guidelines recommend advanced biologic therapies like infliximab and adalimumab as first-line treatments, rather than the traditional “step-up” approach. This shift is designed to provide more effective and faster interventions for moderate-to-severe Crohn’s disease. Although this change may lead to better outcomes, insurance coverage could be a barrier to broader access to these treatments.

The European League Against Rheumatism, or EULAR, has introduced a new disease activity score for antiphospholipid syndrome, known as EAPSDAS. This score will help clinicians track disease activity and treatment response more accurately. With separate scales for thrombotic and obstetric manifestations, EAPSDAS is designed to improve management and adjust treatments more precisely, benefiting both clinical trials and routine care.

Biogen and Dayra Therapeutics have announced a collaboration to develop oral macrocyclic peptides for immunological conditions. These peptides could provide biologic-like efficacy in an oral form, offering a more convenient alternative to traditional biologics. This partnership holds the potential to deliver innovative and cost-effective treatments for autoimmune diseases, improving patient access to therapies.

AstraZeneca’s Imfinzi has been approved in the U.S. as the first and only perioperative immunotherapy for early gastric and gastroesophageal cancers. Based on Phase III data, Imfinzi, in combination with chemotherapy, showed a 29% reduction in the risk of disease progression and a 22% reduction in the risk of death compared to chemotherapy alone. This approval establishes a new standard of care, offering improved survival outcomes for patients with resectable gastric and gastroesophageal junction cancers.

AbbVie’s SKYRIZI has received a positive reimbursement recommendation for ulcerative colitis in Canada, following positive Phase III trial results. This recommendation is expected to improve access to SKYRIZI for Canadian patients, providing a new treatment option for those suffering from ulcerative colitis and addressing a significant need in inflammatory bowel disease care.

Daewoong Pharmaceutical has launched Zeltopa tablets, a low-cost version of Xeljanz (tofacitinib) for autoimmune diseases. Zeltopa offers the same therapeutic efficacy and safety as the original drug, but at a significantly lower price. This affordable alternative can improve access to treatment for patients with rheumatoid arthritis, psoriatic arthritis, and other autoimmune conditions, particularly in regions where cost is a significant barrier.

Finally, InnoCare has dosed the first patient in a global Phase II trial of Soficitinib, a TYK2 inhibitor for prurigo nodularis. Soficitinib targets cytokines involved in itching and inflammation, offering a potential treatment for this condition. If successful, it could provide a much-needed option for patients with prurigo nodularis, a skin condition with no effective therapies available.

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Why it matters

Dupixent’s approval [1] offers breakthrough treatment for chronic spontaneous urticaria in the EU, addressing a long-neglected condition.
Crohn’s disease guidelines [2] advocate for more aggressive, evidence-based treatments as the first line of care, which could improve patient outcomes.
EULAR’s new disease activity score [3] for APS introduces a novel way to monitor disease progress, helping improve treatment strategies.
Biogen and Dayra’s collaboration [4] on oral macrocyclic peptides could revolutionize treatment for immunological diseases, offering convenience and efficacy in oral form.
Imfinzi’s approval [5] for gastric and GEJ cancers sets a new standard in perioperative cancer therapy, offering substantial survival benefits.
SKYRIZI’s positive recommendation [6] in Canada improves access to targeted biologic therapy for UC, addressing a key gap in the treatment landscape.
Zeltopa’s launch [7] provides a cost-effective alternative to existing JAK inhibitors, reducing financial barriers to treatment for autoimmune diseases.
Soficitinib’s Phase II trial [8] could offer a new treatment option for prurigo nodularis, a challenging dermatological condition.

🗓️ Explore weekly details and sources

Week 19–25 November 2025
Week 26 November–2 December 2025

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

FAQ

What makes Dupixent a breakthrough for CSU?

Dupixent is the first targeted treatment approved for CSU in over a decade, offering significant relief from itch and hives, with a proven safety profile [1].

How do the new Crohn’s guidelines impact treatment?

The guidelines recommend using advanced monoclonal antibodies as first-line treatment, rather than relying on less effective drugs, potentially improving patient outcomes [2].

What is EULAR’s new disease activity score for APS?

EULAR developed a new activity score (EAPSDAS) for APS that can help clinicians track disease activity and assess treatment response, offering better management of the condition [3].

What is the significance of Biogen and Dayra’s collaboration?

The collaboration focuses on developing oral macrocyclic peptides for immunological diseases, potentially offering biologic-like efficacy in an oral form [4].

How does Imfinzi’s approval change cancer treatment?

Imfinzi’s approval provides a new standard of care for early gastric and GEJ cancers, offering improved survival rates with a perioperative regimen [5].

How will SKYRIZI help UC patients in Canada?

SKYRIZI’s positive reimbursement recommendation offers a new, effective treatment option for moderately to severely active UC patients in Canada [6].

What makes Zeltopa an important launch?

Zeltopa’s cost-effective alternative to Xeljanz could make JAK inhibitors more accessible to patients with autoimmune diseases [7].

What is Soficitinib’s potential for prurigo nodularis?

Soficitinib could provide a promising treatment for prurigo nodularis, targeting inflammation and itching, with a novel approach in dermatology [8].

Entities / Keywords

Dupixent, Sanofi, Regeneron, chronic spontaneous urticaria, CSU.
Crohn’s disease, guidelines, monoclonal antibodies.
EULAR, APS, disease activity score, EAPSDAS.
Biogen, Dayra Therapeutics, oral macrocyclic peptides, immunology.
Imfinzi, AstraZeneca, gastric cancer, GEJ cancer, MATTERHORN.
SKYRIZI, AbbVie, ulcerative colitis, Canada.
Zeltopa, Daewoong Pharmaceutical, JAK inhibitors, autoimmune diseases.
Soficitinib, InnoCare Pharma, prurigo nodularis, TYK2 inhibitor.