Jyseleca (filgotinib) / Galapagos, Gilead, Eisai, SOBI, Alfasigma - LARVOL DELTA

Efficacy of Filgotinib in Patients With Ulcerative Colitis: A Systemic Review and Meta-Analysis (ACG 2025) - "It has improved drug clearance and is effective in both biologic-naïve as well as biologic-failed patients (TNF antagonists, Vedolizumab, etc. used as first-line treatment) and has been studied through clinical trials such as the SELECTION trial. The study includes a total of 10 papers with 2710 subjects receiving Filgotinib therapy and 2130 patients under standard care/placebo for UC. The OR of Complete remission of Ulcerative Colitis was not statistically significant in both groups indicating similar clinical efficacy in both groups.{OR=1.31 (0.94; 1.82)} , 95% CI , p< 0.01 ,I^2=86%). Pooled proportion of Complete remission of UC was assessed in 2 different drug doses among induction and maintenance phases."

Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • JAK1

A Systematic Review and Bayesian Network Meta-Analysis (ACG 2025) - "Introduction: Crohn's disease, a chronic Inflammatory bowel disease, has limited treatments with variable efficacy and side effects. A total of 12 RCTs with 25 interventions were included involving 5,129 patients.Upadacitinib 45 mg once daily OD showed significant efficacy in achieving clinical remission compared to placebo (HR:2.47; 95% CrI: 1.51–4.10), supported by the highest SUCRA value of 0.79 and a significant MD (MD: 0.907; CrI: 0.410–1.41). For endoscopic remission, Upada 45 mg OD was also superior to placebo (HR: 5.89; CrI: 2.79–13.86), though Upada 24 mg QD had a higher SUCRA value (0.87 vs 0.38). Upada 24 mg QD showed the most favorable trend in clinical response (HR: 2.18; CrI: 0.93–5.22; SUCRA: 0.74) while Upada 45 mg OD had lower effectiveness (HR: 1.25; CrI: 0.82–1.90; SUCRA: 0.30)."

Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Efficacy of Advanced Therapies for Naïve and Experienced Patients for Moderately-to-Severely Active Ulcerative Colitis: A Bayesian Network Meta-Analysis (ACG 2025) - "ADA, adalimumab; CrI, credible interval; ETS, etrasimod; FIL, filgotinib; GOL, golimumab; GUS, guselkumab; IFX, infliximab; MIR, mirikizumab; OZN, ozanimod; PBO, placebo; RR, relative risk; RZB, risankizumab; TOF, tofacitinib; UPA, upadacitinib; UST, ustekinumab; VDZ, vedolizumab. Four additional studies each for induction and maintenance were included. Results of pairwise comparisons across agents from the 2022 NMA were consistent. For additional agents, most pairwise comparisons had no significant difference at the end of induction and maintenance (Figs 1 & 2).For AT-N induction clinical remission, MIR 300mg was significantly less effective vs RZB 1200mg (RR, 0.7; 95% CrI, 0.5-1.0) and GUS 200mg was favored vs MIR 300mg (1.6, 1.1-1.2)."

Metastases • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

JAK Inhibitors for Crohn's Disease: A Systematic Review and Network Meta-Analysis of Efficacy and Safety (ACG 2025) - "Nine RCTs (n = 4838) evaluated Upadacitinib (UPA), Tofacitinib (TOFA), and Filgotinib (FIL) at multiple doses. Upadacitinib 45 mg once daily demonstrated the greatest benefit in achieving CDAI (Crohn's Disease Activity Index) remission compared to placebo (RR = 1.8, 95% CrI [1.1–3.0]). SUCRA rankings showed that UPA ranked highest for overall clinical and CDAI remission."

Retrospective data • Review • Cardiovascular • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Septic Shock

Efficacy of Biologics and Small Molecules for Induction of Response and Remission in Fistulizing Crohn's Disease: A Network Meta-Analysis of Randomized Controlled Trials (ACG 2025) - "Regarding response, Infliximab plus Ciprofloxacin (OR 25.7; 95% CI 2.43-273), Infliximab 5 mg/kg (OR 6.04; 95% CI 1.53-23.8), Upadacitinib (OR 13.7; 95% CI 1.42-133.2), and Ustekinumab (OR 2.50; 95% CI 1.08-5.76) significantly improved clinical outcomes compared to placebo (Fig.4)...Vedolizumab and Filgotinib did not demonstrate superiority over placebo in either remission or response. This analysis suggests that combination therapies, particularly those involving anti-TNF agents with antibiotics and novel agents, such as Upadacitinib, are associated with the most favorable induction of clinical remission and response in FCD... Thirteen RCTs were included to evaluate the efficacy of 14 advanced therapies. The predominant phenotype observed among the study participants was perianal FCD. For remission, Adalimumab plus Ciprofloxacin (OR 6.59; 95% CI 1.27-34.2), Infliximab 5 mg/kg (OR 3.83; 95% CI 1.82-8.05), and Upadacitinib (OR 5.67; 95% CI 1.11-29.03) significantly..."

Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

Efficacy of Biologic Agents and Small Molecules for Endoscopic Improvement and Mucosal Healing in Patients with Moderate-to-Severe Ulcerative Colitis: Systematic Review and Meta-Analysis. (PubMed, J Clin Med) - "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)...Risankizumab showed the highest efficacy (RR 10.25, 95% CI: 2.49-42.11)... 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."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Comparative effectiveness and safety of tofacitinib and filgotinib in patients with ulcerative colitis: A propensity score-weighted cohort study. (PubMed, Dig Liver Dis) - "TOFA and FILGO demonstrated similarly high effectiveness and persistence in real-world UC patients. Both had acceptable safety profiles."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • JAK1

Single-Center Cross-Sectional Analysis of Patients with RA, SpA, and PsA: Data from the Prescription Database. (PubMed, J Pers Med) - "For RA, 34.2% of patients were difficult to treat (D2T) (98 pt), 54.8% (157 pt) were in monotherapy (tocilizumab-sarilumab-upadacitinib-filgotinib). Abatacept was the most prescribed treatment in RF and ACPA-positive patients and in those with ILD. The anti-IL-17A secukinumab was prescribed in 12% of SpA, of which 71% had enthesitis and dactylitis (14 pt). Ixekizumab was prescribed in 10.4% of PsA patients over 65 years with previous CV events, enthesitis, and dactylitis (21 pt). Apremilast was present in 71% of PsA with previous cancer...The cross-sectional analysis of prescriptions in patients with RA, SpA, and PsA demonstrates how the ITABIO recommendations can guide towards the correct appropriateness of prescription. RA and especially D2T-RA remains the disease with the greatest therapeutic failures, with the highest percentage of monotherapy (anti-IL-6 and Jak-i) and of discontinuation of MTX."

Journal • Ankylosing Spondylitis • Cardiovascular • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Interstitial Lung Disease • Metabolic Disorders • Ocular Inflammation • Oncology • Ophthalmology • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL17A

SHORT AND LONG-TERMS EFFECTIVENESS COMPARISONS BETWEEN TOFACITINIB, FILGOTINIB AND UPADACITINIB IN BIO-EXPOSED PATIENTS WITH ULCERATIVE COLITIS: RESULTS FROM THE JAKARTA REAL-WORLD EVIDENCE MULTICENTER STUDY (UEGW 2025) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

WEEK 10 EFFECTIVENESS AND SAFETY OF FILGOTINIB IN PATIENTS WITH ULCERATIVE COLITIS: AN INTERIM ANALYSIS OF THE PROSPECTIVE, REAL-WORLD EVIDENCE GALOCEAN STUDY (UEGW 2025) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH) (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: R.Bos | Trial completion date: Apr 2023 ➔ Sep 2025 | Trial primary completion date: Mar 2023 ➔ Sep 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

BASELINE CHARACTERISTICS ASSOCIATED WITH ACHIEVING EFFICACY ENDPOINTS IN PATIENTS WITH ULCERATIVE COLITIS TREATED WITH FILGOTINIB (UEGW 2025) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Filgotinib real-world effectiveness and safety in patients with moderately and severely active ulcerative colitis: an early interim analysis of GALOCEAN (BSG 2025) - P, P2b | "Numerically greater proportions of patients with moderately active UC achieved remission and clinically meaningful improvements in patient-reported outcomes than those with severely active UC, particularly at week 10. The safety profile was similar between groups"

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • JAK1

REAL-WORLD 12-MONTH MAINTENANCE PERIOD DATA IN ULCERATIVE COLITIS PATIENTS INITIATING FILGOTINIB THERAPY: FINDINGS FROM THE PROSPECTIVE FILGOCOLITIS STUDY ON CLINICAL EFFECTIVENESS AND NOVEL WEARABLE-DERIVED OUTCOMES (UEGW 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

INTESTINAL ULTRASOUND AND SHEAR-WAVE ELASTOGRAPHY: KINETICS IN ULCERATIVE COLITIS PATIENTS TREATED WITH FILGOTINIB (UEGW 2025) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

FILGUITO: ONE-YEAR REAL-WORLD EFFECTIVENESS AND SAFETY OF FILGOTINIB IN ULCERATIVE COLITIS – RESULTS FROM A MULTICENTER ANDALUSIAN REGISTRY (UEGW 2025) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Olinguito: A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=495 | Active, not recruiting | Sponsor: Alfasigma S.p.A. | Trial completion date: Jul 2026 ➔ Dec 2028

Trial completion date • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Long-term efficacy and safety of filgotinib 200 mg in ulcerative colitis: 5-year interim data from SELECTIONLTE (BSG 2025) - P2b, P3 | "NRI analyses showed similar but more conservative results than observed analyses for both groups for both endpoints.Conclusions FIL200 was effective in maintaining symptomatic remission and health-related quality of life for up to 5 years. No new safety signals were identified, and rates of AEs with long-term FIL exposure were similar to those previously reported.1 2 Prolonged treatment with filgotinib is efficacious for the long-term management of UC, and together with its proven safety profile, results in an acceptable benefit–risk profile"

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • JAK1

Is 2nd JAKi treatment for UC worth the effort? A retrospective, multi-Centre UK study. (PubMed, J Crohns Colitis) - "In this highly refractory cohort with active UC a second JAKi effectively achieved remission following IR to first JAKi. Type of first JAKi failure did not appear to influence clinical remission. No new safety signals were found."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

REAL-WORLD EFFICACY AND SAFETY OF FILGOTINIB IN ULCERATIVE COLITIS: RESULTS FROM THE ENEIDA REGISTRY (UEGW 2025) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Filgotinib Shows Positive Topline Results Across Full Spectrum of Axial Spondyloarthritis in OLINGUITO Phase 3 Study (Businesswire) - P3 | N=495 | OLINGUITO (NCT05785611) | Sponsor: Alfasigma S.p.A. | "Alfasigma S.p.A today announced positive topline results from the OLINGUITO Phase 3 clinical trial...evaluating filgotinib (marketed as Jyseleca in approved indications) to treat adult patients with active axial spondyloarthritis (axSpA). Filgotinib, an oral, once-daily JAK1 preferential inhibitor, met the primary endpoint in the OLINGUITO Phase 3 clinical trial in active axSpA. Efficacy was demonstrated across the full spectrum of axSpA, including both radiographic (r-axSpA) and non-radiographic (nr-axSpA) forms. The safety profile was consistent with previous studies, with no unexpected events observed....Alfasigma plans to submit data from the OLINGUITO Phase 3 clinical trial to European Medicines Agency (EMA) and UK’s Medicines Healthcare products Regulatory Agency (MHRA) to seek market authorization for filgotinib in the treatment of adults with active axial spondyloarthritis (axSpA)."

P3 data: top line • Spondylarthritis

FILGOTINIB EFFECTIVENESS AND SAFETY AS SECOND OR THIRD-LINE THERAPY IN PATIENTS WITH ULCERATIVE COLITIS: DATA FROM A REAL-WORLD STUDY (UEGW 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PRECISION-CUT INTESTINAL SLICES PROVIDE EX VIVO ASSESSMENT OF REGION-SPECIFIC IMMUNE RESPONSES AND EFFICACY OF FILGOTINIB IN CROHN'S DISEASE (UEGW 2025) - No abstract available

Preclinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

COMPARATIVE EFFECTIVENESS AND SAFETY OF TOFACITINIB AND FILGOTINIB IN PATIENTS WITH ULCERATIVE COLITIS: A PROPENSITY SCORE-WEIGHTED COHORT STUDY (UEGW 2025) - No abstract available

Clinical • HEOR • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

GALOCEAN: Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) (clinicaltrials.gov) - P=N/A | N=519 | Active, not recruiting | Sponsor: Alfasigma S.p.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis