tofacitinib

For pediatric patients with IBD that is unresponsive to monotherapy, combining biologics and/or small molecules may represent an effective and relatively safe treatment option, achieving high clinical remission rates and improvements in biological markers. However, high-quality prospective studies are needed to confirm long-term efficacy and safety.

P3, N=18, Completed, University of Texas Southwestern Medical Center | Active, not recruiting --> Completed | Trial completion date: Jun 2027 --> Oct 2025

LAVs were not associated with an increased risk of adverse outcomes within one day to six months among IBD patients receiving immunomodulatory therapy. These real-world findings suggest comparable short-term outcomes between the cohorts of patients with IBD receiving biologic or targeted synthetic therapy who met the predefined eligibility criteria including age ≥ 18 years, and vaccination occurring between two weeks and six months after biologic initiation regarding LAV use in patients with IBD receiving biologic agents.

This human 3D multicellular in vitro spheroid model of synovial inflammation recapitulates key RA pathological processes and provides a robust platform for mechanistic studies and therapeutic evaluation.

National centralized procurement policy achieved dramatic cost reductions (e.g., tofacitinib DDDc decreased by 93.3%), directly driving increased utilization of tsDMARDs and bDMARDs. This study provides empirical evidence that aggressive pharmaceutical pricing policies can rapidly improve access to advanced rheumatologic therapies in resource-limited settings, offering a replicable model for healthcare systems worldwide. Key Points • Overall disease-modifying antirheumatic drugs (DMARDs) use showed modest growth from 2018 to 2022. • tsDMARDs and bDMARDs exhibited rapid increases in use and revenue. • Methotrexate and leflunomide remained key csDMARDs in clinical practice.

P4, N=10, Not yet recruiting, University of California, San Francisco | Initiation date: Jan 2026 --> Aug 2026

P=N/A, N=102, Completed, Pfizer | Recruiting --> Completed | Trial completion date: Mar 2026 --> Sep 2025 | Trial primary completion date: Mar 2026 --> Sep 2025

Risk of bias was assessed using ROBIS.RESULTSAnti-TNF monoclonal antibodies (infliximab, adalimumab) were consistently associated with the highest TB risk (odds ratio commonly 3-5), with greater proportions of disseminated/extra-pulmonary disease compared to etanercept...JAK inhibitors (notably tofacitinib) conferred geographically variable risk, higher in intermediate/high-burden countries. Immune checkpoint inhibitors, especially PD-1/PD-L1 agents, were linked to TB incidence far above background rates.CONCLUSIONTB risk varies markedly across biologic and targeted agents. Risk-based TB infection screening and tailored prophylaxis beyond anti-TNF therapy are warranted, particularly in endemic regions..

P3, N=400, Recruiting, Duke University | Trial primary completion date: Jun 2026 --> Dec 2026

P1/2, N=12, Not yet recruiting, Centre Hospitalier De Versailles

P3, N=459, Active, not recruiting, Hangzhou Highlightll Pharmaceutical Co., Ltd | Trial completion date: Dec 2028 --> Dec 2026 | Trial primary completion date: Jul 2026 --> Jan 2026

P3, N=459, Active, not recruiting, Hangzhou Highlightll Pharmaceutical Co., Ltd | Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Dec 2028 | Trial primary completion date: Feb 2025 --> Jul 2026