Filgotinib 200mg tablets

Background and Aim: The therapeutic landscape for ulcerative colitis (UC) is rapidly evolving, with an increasing number of biologic agents available. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) data on biologic therapies for achieving key endoscopic and histologic endpoints in moderate to severe UC. Methods: A systematic search of MEDLINE, EMBASE, Cochrane Library, Web of Science and grey literature was conducted through November 2024. Separate meta-analyses were performed for induction and maintenance. A random-effects model was used to estimate relative risks (RR), with 95% confidence intervals (CI), and confidence in estimates was evaluated with the GRADE approach (Grading of Recommendation Assessment, Development and Evaluation). Results: We included 40 RCTs (13 therapies, 14,369 patients). Thirty-two trials provided data in induction and twenty-eight in maintenance. During induction, all biologic therapies, except mirikizumab and filgotinib 100 mg, demonstrated superiority over placebo (RR 2.02, 95% CI: 1.76-2.31, I2 = 72%) for endoscopic improvement. Upadacitinib showed the highest efficacy (RR 5.53, 95% CI: 3.78-8.09). For mucosal healing, all interventions were superior to placebo (RR 2.95, 95% CI: 2.11-4.13, I2 = 61%), except filgotinib 100 mg. Risankizumab showed the highest efficacy (RR 10.25, 95% CI: 2.49-42.11). In maintenance, all therapies showed superiority over placebo for endoscopic improvement. For mucosal healing all therapies were superior to placebo, except risankizumab. Upadacitinib 30 mg showed the highest efficacy (RR 4.01, 95% CI: 1.81-8.87). Conclusions: Biologic and small-molecule therapies demonstrated substantial efficacy in achieving key endpoints. Standardized outcome definitions and further head-to-head RCTs are essential to strengthen confidence in our findings.

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ObjectiveThis study compared the efficacy of different doses of filgotinib (100 mg vs 200 mg) in the treatment of rheumatoid arthritis (RA).MethodsWe conducted a systematic review of 4 electronic databases up to January 2025. Primary outcome measures included ACR20, ACR50, ACR70.ResultsFive RCTs were included in this analysis, in which 2191 patients with RA were evaluated, 100 mg filgotinib was noninferior to 200 mg filgotinib in the efficacy of ACR20 (P = 0.33, RR = 0.96). However, 100 mg filgotinib was inferior to 200 mg filgotinib for RA when using ACR50 (P = 0.04, RR = 0.92) and ACR70 (P = 0.02, RR = 0.86) as outcome measures. At 24 weeks, 100 mg filgotinib was inferior to 200 mg filgotinib at ACR50 (P = 0.07, RR = 0.84), and there was no significant difference between 100 mg and 200 mg filgotinib at ACR70 (P = 0.54, RR =0.88). The 52-week results showed 100 mg filgotinib was inferior to 200 mg filgotinib at ACR70 (P = 0.01, RR = 0.86).ConclusionReduced dose filgotinib (100 mg) may be used as a potential treatment option for RA when treatment is required.

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Abstract Background Accumulating evidence demonstrates the efficacy of interleukin-23 (IL-23) p19 inhibitors and small molecule drugs in the treatment of Crohn's disease (CD), with several agents advancing toward regulatory approval. This study aimed to compare the efficacy and safety of IL-23p19 inhibitors and small molecule drugs as induction therapy in CD. Methods Literature searches were updated to August 2025. Efficacy endpoints included clinical remission, endoscopic improvement/remission. Safety analysis focused on adverse events and serious adverse events. Employing a frequentist framework, we calculated surface under the cumulative ranking (SUCRA) scores for treatment rankings (higher SUCRA indicates better efficacy/safety). Exploratory subgroup analyses were conducted based on prior biologic failure. Results 11 RCTs met inclusion criteria. Subcutaneous guselkumab (SUCRA 93.2%), intravenous guselkumab (88.9%) and risankizumab (72.0%) emerged as the top-ranked agents for inducing clinical remission. Particularly, guselkumab ranked highest in both patients with prior biologic failure (96.3%) and without prior biologic failure (91.2%). Upadacitinib ranked highest for inducing endoscopic improvement (96.2%), patient-reported outcomes remission (91.1%) and endoscopic remission (92.2%). Safety analysis revealed that risankizumab ranked highest for both adverse events (81.5%) and serious adverse events (92.1%), whereas upadacitinib ranked lowest for adverse events (8.4%) and filgotinib 100mg ranked lowest for serious adverse events (11.2%). Conclusions Guselkumab represents a particularly favorable option for inducing clinical remission in CD, irrespective of prior biologic failure. Based on a comprehensive comparison of multiple outcomes, both guselkumab and upadacitinib are recommended as second-line therapies for CD. IL-23p19 inhibitors exhibited a more favorable safety profile than upadacitinib in CD management.

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Rheumatoid arthritis (RA) is a progressive autoimmune disease with systemic involvement and is characterized by synovial inflammation, unremitting joint destruction, and systemic involvement. While biologic disease-modifying antirheumatic drugs (bDMARDs) and conventional synthetic DMARDs (csDMARDs) form the foundation of treatment, limitations such as incomplete efficacy, parenteral administration, and adverse events highlight the need for alternative strategies. Janus kinase inhibitors (JAKis), a newer class of targeted synthetic DMARDs (tsDMARDs), offer the advantages of oral administration, rapid onset, and broad cytokine modulation, thereby potentially offering advantages over established therapies. This review utilizes synthesized data from peer-reviewed clinical trials, systematic reviews, meta-analyses, regulatory documents, and international guidelines. Only studies involving adult patients with RA treated by approved JAKis (baricitinib, tofacitinib, upadacitinib, peficitinib, and filgotinib) were included. Both real-world observational studies and randomized controlled trials were assessed for efficacy, safety, drug interaction, and long-term outcomes. JAKis consistently demonstrated superior responses compared with placebo and methotrexate, with higher American College of Rheumatology 20% response rates, improved disease activity scores, reduced radiographic progression, and enhanced patient-reported outcomes. In head-to-head comparisons, baricitinib and upadacitinib demonstrated advantages over adalimumab across multiple efficacy domains. However, safety concerns emerged, particularly regarding major adverse cardiovascular events, herpes zoster, and malignancy. While randomized controlled trials showed low absolute event rates, observational studies revealed higher risks compared with tumor necrosis factor inhibitors, especially among older patients, smokers, and those with cardiovascular comorbidities. JAKis represent a highly effective and convenient therapeutic option in RA management, offering significant improvements over csDMARDs and certain biologic agents. Nonetheless, their use requires individualized, risk-stratified decision-making, with particular caution in patients at elevated cardiovascular or malignancy risk. Ongoing long-term studies and real-world data remain essential to further define their benefit-risk profile and optimize their integration into personalized RA care.

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