MedBulletinsAura Celeste
Rheumatology

Monthly rheumatology bulletin — October 18, 2026

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Colleagues: this issue covers September 18 to October 18, 2026. It was a transition month ahead of ACR Convergence (November 6–11): few large trials published, several regulatory decisions, and industry-reported results that still lack peer-reviewed numbers. We include seven verified items. In this period we found no new, verifiable data on osteoporosis, ANCA-associated vasculitis, or CAR-T therapy published as a trial, and no regional data from Latin America and the Caribbean; we would rather say so than pad the issue.

1. Rheumatoid arthritis and spondyloarthritis

1. Halving biologic or JAK inhibitor exposure in stable rheumatoid arthritis is noninferior at 24 weeks

[Clinical trial] [South Korea]

Randomized, open-label, multicenter, 24-week noninferiority trial in 348 patients with rheumatoid arthritis in low disease activity (DAS28-ESR) for at least 6 months on biologic or targeted synthetic DMARDs: 171 assigned to a stepwise 50% dose reduction and 177 to continue usual dosing. In the per-protocol analysis, low disease activity was maintained at week 24 in 88.2% with tapering vs 89.6% with usual dosing (difference −1.43 percentage points; 95% CI −8.09 to 5.23; prespecified noninferiority margin −10 points). The study was led from Chonnam National University. Published in Arthritis & Rheumatology (covered by Medical Dialogues on October 14).

Why it matters: it supports tapering in stable patients, which matters where cost limits access, as in the Dominican Republic; but follow-up was only 24 weeks, the design was open-label, and there are no data on radiographic progression; the authors themselves call for longer-term studies.

https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.70363

https://medicaldialogues.in/orthopaedics/news/half-dose-reduction-of-targeted-therapies-maintains-disease-control-in-rheumatoid-arthritis-study-181265

2. Lupus, vasculitis and inflammatory myopathies

2. Positive EMA CHMP opinion for secukinumab in polymyalgia rheumatica

[Regulatory EMA] [European Union]

On September 18, the EMA published the highlights of the meeting of its Committee for Medicinal Products for Human Use (CHMP, September 14–17), which recommended an extension of indication for secukinumab, pending a European Commission decision; Novartis announced the same day that the extension is for polymyalgia rheumatica. It rests on REPLENISH, a randomized, double-blind, placebo-controlled phase 3 trial in 27 countries (secukinumab 300 mg or 150 mg vs placebo, all with a 24-week glucocorticoid taper), published in NEJM and presented at the EULAR Congress on June 3. According to Novartis, both doses met the primary and all secondary endpoints, and secukinumab doubled the sustained remission rate at 52 weeks vs placebo; the release does not give the percentages.

Why it matters: according to Novartis, it would be the first IL-17A inhibitor approved in Europe for polymyalgia rheumatica and an option for steroid-dependent patients; the final European Commission decision is pending, the remission rates should be read in the NEJM paper, and, in our setting, access and cost will be the limiting factor.

https://ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026

https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-cosentyx-polymyalgia-rheumatica-pmr

3. Dazodalibep meets primary endpoint in systemic Sjögren's disease

[Industry] [United States / multinational]

Amgen announced on September 22 that OASIZ 301 (phase 3, randomized, double-blind, placebo-controlled; about 621 adults with Sjögren's disease and moderate-to-severe systemic activity, ESSDAI ≥5, per the release) met its primary endpoint: a statistically significant improvement from baseline in ESSDAI at week 48, with improvement observed as early as week 4. Most common adverse events (≥5% and higher than placebo): nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, with no imbalance in thromboembolic events or opportunistic infections.

Why it matters: CD40L pathway blockade opens a treatment avenue in a disease that, according to Amgen, has no FDA-approved medicines; but this is a manufacturer press release without effect size, confidence intervals, or P values, and the full presentation is needed.

https://www.amgen.com/newsroom/press-releases/2026/09/amgen-announces-positive-topline-phase-3-results-for-dazodalibep-in-moderatetosevere-systemic-sjgrens-disease

4. Litifilimab in cutaneous lupus: sustained response at 52 weeks

[Congress] [Austria / multinational]

Presented October 2 at the European Academy of Dermatology and Venereology Congress (Vienna): in the phase 2 portion of the phase 2/3 AMETHYST study (randomized, double-blind, placebo-controlled; 93 adults with subacute or chronic cutaneous lupus refractory or intolerant to antimalarials), CLASI-70 was 21.7% with litifilimab vs 5.8% with placebo at week 24, and 28.8% at week 52 among those treated with litifilimab from randomization; from week 24 all participants received litifilimab. Serious adverse events in 3 of 88 patients (3.4%) during the extended period.

Why it matters: the anti-BDCA2 antibody continues to show signal in a refractory population with few options, but the 52-week data lack a comparator, the sample is small, and the data are not peer reviewed; phase 3 is expected in the first half of 2027.

https://www.biopharminternational.com/view/litifilimab-amethyst-cutaneous-lupus-erythematosus

https://www.globenewswire.com/news-release/2026/10/02/3373899/0/en/index.html

3. Gout, osteoarthritis and osteoporosis

5. Allopurinol escalation can continue despite mild aminotransferase elevations

[Publication] [Singapore]

Prospective cohort of 150 patients with gout and normal aminotransferases starting allopurinol escalation (95.3% men; median follow-up 33.5 weeks). Twenty percent developed AST/ALT elevation, mild in 86.7% and never severe. Of 19 patients with elevation at the second visit, 18 maintained or increased the dose; at the next visit, the elevation in these patients was stable in 27.8%, improved in 11.1%, and resolved in 33.3%. Elevation was associated with alcohol use (adjusted OR 3.52; 95% CI 1.41–8.79) and statin non-use (adjusted OR 3.41; 95% CI 1.04–11.17), not with allopurinol dose (P = .193). Published in Arthritis Care & Research (covered by Healio on October 13).

Why it matters: it supports not stalling treat-to-target urate lowering because of mild aminotransferase rises, a common practice error; it is a small observational study in an Asian, almost exclusively male population and should be replicated.

https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.80157

https://www.healio.com/news/rheumatology/20261012/allopurinol-safely-escalated-in-gout-despite-mild-liver-enzyme-elevation

6. The Lancet publishes a global policy roadmap for osteoarthritis

[Publication] [Australia / international]

On World Arthritis Day (October 12), an international team with experts from 18 countries, led from Curtin University, published a health policy roadmap in The Lancet: about 600 million people with osteoarthritis in 2023, nearly one billion projected by 2050, and a 65% increase in the disability burden attributable to osteoarthritis between 1990 and 2023. It proposes three priorities: recognize the disease through national burden and cost data and include musculoskeletal health in national policy; expand affordable, person-centred care integrated into primary and chronic disease care; and slow its growth by addressing excess body weight and joint injuries, including workplace and sports injuries.

Why it matters: it is a policy document, not a trial, but it provides arguments and figures for including osteoarthritis in chronic disease programs in countries such as the Dominican Republic.

https://www.curtin.edu.au/research/news/nearly-one-billion-people-could-live-with-osteoarthritis-by-2050-international-experts-warn?type=media

https://www.medicalrepublic.com.au/?p=129920

Osteoporosis: we found no new verifiable publications or regulatory decisions in this period. World Osteoporosis Day is October 20.

4. Biologic and targeted therapies, biosimilars

7. Upadacitinib approved in the European Union for polyarticular juvenile idiopathic arthritis

[Regulatory European Commission] [European Union]

AbbVie announced on September 22 the European Commission approval of upadacitinib for active polyarticular juvenile idiopathic arthritis (RF-positive or RF-negative and extended oligoarthritis) from age 2, after inadequate response or intolerance to one or more DMARDs, as monotherapy or with methotrexate (15 mg tablet and weight-based 1 mg/mL oral solution). The basis is SELECT-YOUTH, a phase 1, open-label, single-arm study of 122 patients aged 2 to under 18: at week 48, 79.5% achieved ACR Pedi 70 and 43.4% remission (JADAS27-CRP ≤1). According to AbbVie, no new safety risks were identified, no major cardiovascular or thrombotic events, malignancies, or deaths were reported, and no negative impact on growth was observed.

Why it matters: the oral solution is useful in young children; but the evidence comes from a small, open-label study without a comparator, and long-term safety of JAK inhibitors in children remains to be defined.

https://news.abbvie.com/2026-09-22-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Children-with-Active-Polyarticular-Juvenile-Idiopathic-Arthritis

Cross-cutting

Guidelines, AI and Latin America: in this period we found no new guidelines from ACR, EULAR, PANLAR or the Dominican Society of Rheumatology, and no rheumatology approvals from ANVISA, COFEPRIS or DIGEMAPS with a verifiable date. The German Rheumatology Congress (Leipzig, September 9–12) fell outside the period.

Upcoming meetings and dates

  • October 20: World Osteoporosis Day (International Osteoporosis Foundation).
  • October 29: expected FDA decision on tildrakizumab in psoriatic arthritis.
  • November 6–11: ACR Convergence 2026, Orlando, Florida.

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