This biweekly video brings you key highlights from across the immunology landscape, featuring the latest data releases, company updates, and research milestones.
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:08 Novartis: Cosentyx achieves Phase III success in polymyalgia rheumatica (PMR)
0:40 Johnson & Johnson: Tremfya shows durable 96-week remission in Crohn’s disease
1:10 Johnson & Johnson: Nipocalimab reduces Sjögren’s disease activity in Phase 2 DAHLIAS study
1:38 Eli Lilly: Baricitinib drives near-complete hair regrowth in adolescent alopecia areata
2:05 Johnson & Johnson: FDA submission for STELARA in pediatric ulcerative colitis
2:34 AbbVie: RINVOQ delivers positive Phase 3 results in vitiligo
3:00 Novartis: Ianalumab shows benefit in Sjögren’s disease, potential first targeted therapy
3:30 Roche: Gazyva/Gazyvaro reduces disease activity in systemic lupus erythematosus (SLE)
4:01 How to reach us
Transcript
Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
In recent developments, Novartis has announced that Cosentyx® (secukinumab) has achieved both primary and secondary endpoints in its Phase III trial for polymyalgia rheumatica (PMR). The data showed that the treatment led to sustained remission and reduced the need for corticosteroids, suggesting its potential as a novel targeted therapy. This breakthrough could potentially reshape the treatment landscape for PMR, with plans for submission to health authorities in 2026.
Johnson & Johnson’s Tremfya® (guselkumab) has also made significant progress, demonstrating durable remission in Crohn’s disease patients at 96 weeks. The treatment showed high rates of both clinical and endoscopic remission, with subcutaneous administration proving to be effective. Tremfya® could provide a long-term treatment option for patients suffering from moderately to severely active Crohn’s disease, offering flexibility in administration.
In another notable development, Johnson & Johnson’s Nipocalimab has shown promising results in its Phase 2 DAHLIAS study for Sjögren’s disease. The treatment demonstrated a significant reduction in disease activity, improving key symptoms of the condition. The favorable safety profile and significant efficacy of Nipocalimab make it a promising option for this disease, which currently has few approved therapies.
Eli Lilly’s baricitinib has demonstrated near-complete scalp hair regrowth in adolescents with severe alopecia areata in the Phase 3 BRAVE-AA-PEDS trial. The promising data positions baricitinib as a potential first-line treatment for severe alopecia areata in adolescents, addressing a significant unmet need in this population.
Additionally, Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for STELARA® (ustekinumab) to treat pediatric patients with ulcerative colitis. This submission is supported by data from the Phase 3 UNIFI Jr trial and could expand treatment options for children with moderately to severely active ulcerative colitis, providing a critical therapy for this challenging condition.
AbbVie has announced positive Phase 3 results for upadacitinib (RINVOQ®) in adults and adolescents with vitiligo. The treatment demonstrated significant re-pigmentation, marking a major milestone for a disease with limited therapeutic options. If approved, upadacitinib could provide a breakthrough in vitiligo treatment, greatly improving patients’ quality of life.
In further news from Novartis, the company reported positive results from its Phase III trials for ianalumab in Sjögren’s disease. The treatment showed significant improvements in disease activity and patient burden, with the potential to become the first targeted therapy for this condition. Ianalumab could transform care for patients with Sjögren’s disease, offering much-needed treatment options for a condition with few approved therapies.
Finally, Roche has reported positive Phase III results for Gazyva®/Gazyvaro® in systemic lupus erythematosus (SLE). The treatment showed a significant reduction in disease activity, meeting both primary and secondary endpoints. If approved, Gazyva®/Gazyvaro® could become the first anti-CD20 therapy for SLE, offering better disease control and reducing the risk of organ damage.
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Why it matters
- Cosentyx® for PMR: The positive Phase III data could provide a new treatment for PMR, a common inflammatory disease in elderly populations.
- TREMFYA® for Crohn’s disease: Long-term efficacy data suggest that TREMFYA® can provide sustained remission and flexibility in administration for Crohn’s disease patients.
- Nipocalimab for Sjögren’s disease: With significant disease activity reduction and favorable safety, nipocalimab may become a much-needed option for Sjögren’s disease.
- Baricitinib in alopecia areata: Baricitinib’s success in adolescents with alopecia areata brings hope for effective treatments for this underserved population.
- STELARA® for pediatric UC: Expanding STELARA®’s indications for pediatric ulcerative colitis addresses a major gap in treatment options for children.
- Upadacitinib for vitiligo: This marks a significant breakthrough in vitiligo treatment, offering a systemic therapy for re-pigmentation.
- Ianalumab for Sjögren’s disease: Ianalumab showed significant improvements in disease activity in Phase 3 trials for Sjögren’s disease, with the potential to become the first targeted therapy for the disease.
- Gazyva/Gazyvaro in SLE: This new data reinforces the potential of Gazyva/Gazyvaro as a treatment for SLE, offering a targeted therapy to improve disease control.
🗓️ Explore weekly details and sources
Week 22–29 October 2025
Week 30 October – 5 November 2025
📚 Find your one-stop page for the full Immunology archive.
FAQ
What did Novartis report for Cosentyx® in PMR?
Cosentyx® demonstrated sustained remission and reduced steroid use in PMR patients in the Phase III REPLENISH trial, with plans for global regulatory submission [1].
What did Johnson & Johnson show for Tremfya® in Crohn’s disease?
Tremfya® achieved durable remission in patients with moderately to severely active Crohn’s disease in Phase 3 trials, offering a new treatment option for long-term management [2].
How did nipocalimab perform in Sjögren’s disease?
Nipocalimab showed significant improvements in disease activity and symptoms, making it a promising treatment for Sjögren’s disease, a condition with limited therapeutic options [3].
What results did Eli Lilly report for baricitinib in alopecia areata?
Baricitinib achieved significant scalp hair regrowth in adolescents with severe alopecia areata in the BRAVE-AA-PEDS trial, showing its potential as a first-line treatment [4].
What is the new submission for STELARA®?
Johnson & Johnson submitted an sBLA for STELARA® to treat pediatric ulcerative colitis, expanding the treatment options for children with this condition [5].
What did AbbVie show for upadacitinib in vitiligo?
Upadacitinib demonstrated significant re-pigmentation in vitiligo patients in Phase 3 trials, marking a major milestone for treatment of the disease [6].
What is the potential of ianalumab in Sjögren’s disease?
Ianalumab showed significant improvements in disease activity in Phase 3 trials for Sjögren’s disease, with the potential to become the first targeted therapy for the disease [7].
How did Gazyva/Gazyvaro perform in SLE?
Gazyva/Gazyvaro showed significant reduction in disease activity in SLE patients in Phase III trials, positioning it as a promising new treatment for this autoimmune disease [8].
Entities / Keywords
Novartis; Cosentyx®; polymyalgia rheumatica
Johnson & Johnson; Tremfya®; guselkumab; Crohn’s disease
Johnson & Johnson; nipocalimab; Sjögren’s disease
Eli Lilly; baricitinib; alopecia areata
Johnson & Johnson; STELARA®; pediatric ulcerative colitis
AbbVie; upadacitinib; RINVOQ®; vitiligo
Novartis; ianalumab; Sjögren’s disease
Roche; Gazyva/Gazyvaro; systemic lupus erythematosus
References
- https://www.novartis.com/news/media-releases/novartis-cosentyx-meets-primary-and-all-secondary-endpoints-phase-iii-trial-patients-polymyalgia-rheumatica-pmr
- 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
- 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
- https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth
- https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-to-u-s-fda-for-stelara-ustekinumab-in-the-treatment-of-pediatric-ulcerative-colitis
- https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo
- https://www.novartis.com/news/media-releases/novartis-ianalumab-first-drug-reduce-disease-activity-and-patient-burden-sjogrens-disease-phase-iii-trials
- https://www.roche.com/media/releases/med-cor-2025-11-03