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

Emerging role of Janus kinase inhibitors in ulcerative colitis management. (PubMed, World J Gastrointest Pharmacol Ther) - "Tofacitinib is the first approved JAK inhibitor for the treatment of moderate-to-severe UC...These adverse effects have stressed the development of more selective agents such as upadacitinib and filgotinib...This review also highlights future directions, including the potential of selective JAK1 inhibition and the role of personalized medicine in refining therapeutic decisions. Understanding the emerging place of JAK inhibitors within the UC treatment strategies offers excellent opportunities to increase patient care and long-term disease management."

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

Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase. (PubMed, Clin Transl Sci) - "This study analyzed VigiBase, the World Health Organization global pharmacovigilance database of individual case safety reports (ICSRs), to assess signals of disproportionate reporting (SDRs) for pregnancy-related adverse drug reactions (ADRs) reported with systemic JAKIs, including abrocitinib, baricitinib, deucravacitinib, fedratinib, filgotinib, itacitinib, momelotinib, pacritinib, peficitinib, ritlecitinib, ruxolitinib, tofacitinib, and upadacitinib. Findings should be interpreted cautiously given the limitations of spontaneous reporting systems and the exploratory nature of the analysis. Further studies are needed to better characterize the JAKI safety in pregnancy."

Adverse drug reaction • Adverse events • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

PARROTFISH: Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France (clinicaltrials.gov) - P=N/A | N=155 | Active, not recruiting | Sponsor: Alfasigma S.p.A. | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

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

Preventive Effectiveness of Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients Treated with Janus Kinase Inhibitors. (PubMed, Intern Med) - "HZ incidence varied by JAK inhibitor: baricitinib (5.5 vs 9.9), upadacitinib (12.4 vs 6.2), and filgotinib (0.0 vs 1.6) per 100 person-years. Conclusion Although not statistically significant, RZV vaccination tended to reduce the incidence of HZ in Japanese RA patients receiving JAK inhibitors. The effectiveness varied according to the type of JAK inhibitor, with lower lymphocyte counts and higher disease activity, and it may predict insufficient protection."

Journal • Herpes Zoster • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Varicella Zoster

Galapeduca: A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Alfasigma S.p.A. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2027 ➔ Jun 2028

Enrollment open • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Filgotinib Is an Effective and Safe Treatment Option for Difficult-To-Treat Ulcerative Colitis: Real-World Evidence of the Dutch Initiative on Crohn and Colitis (ICC) Registry. (PubMed, United European Gastroenterol J) - "Filgotinib is an effective and well-tolerated treatment option for UC, including DTT disease. No new safety signals were found."

HEOR • Journal • Real-world evidence • Crohn's disease • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Metabolic Disorders • Pain • Ulcerative Colitis • CRP • JAK1

Filgotinib Effectiveness in Rheumatoid Arthritis: Observational Analysis of a Large Multicenter Cohort. (PubMed, Rheumatol Ther) - "This analysis of real-world patients with RA demonstrated the effectiveness of FIL with a good DAS28-CRP response and high DRR at follow-up."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Janus Kinase Inhibitor Discontinuation at a UK Tertiary Centre: A Retrospective Study (Cureus) - "Of 400 patients, 102 (25.5%) discontinued their JAK inhibitors. Primary inefficacy was the most common discontinuation reason, reported in 35/102 patients (34.3%), followed by side effects in 25/102 patients (24.5%). Discontinuation rates varied among the drugs, with tofacitinib (33/64; 51.6%) and baricitinib (57/243; 23.5%) having higher overall discontinuation rates, and upadacitinib and filgotinib showing higher early discontinuation."

Retrospective data • Inflammatory Arthritis

JAK inhibitors in the management of extra-intestinal manifestations in inflammatory bowel disease. (PubMed, Therap Adv Gastroenterol) - "Recently, the development of Janus Kinase (JAK) inhibitors has expanded the therapeutic options of luminal IBD, and three JAK inhibitors, tofacitinib, upadacitinib, and filgotinib, have been approved for IBD treatment, while a growing body of evidence suggests that JAK inhibitors may be a promising therapeutic option for the management of EIMs, particularly those affecting the joints and skin. In this comprehensive review, we aim to provide the available evidence concerning the impact of JAK inhibitors on EIMs treatment and analyze their underlying mechanisms of action."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

EFFECT-1LAT: Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population (clinicaltrials.gov) - P=N/A | N=4000 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Oct 2025 ➔ Mar 2026 | Initiation date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

JAK1-selective inhibitors versus pan-JAK inhibitors: comparative real-world study of drug retention in chronic inflammatory arthritis. (PubMed, Ther Adv Musculoskelet Dis) - "Tofacitinib and baricitinib are pan-JAK inhibitors, while upadacitinib and filgotinib are JAK1-selective inhibitors...Multivariate analysis confirmed that pan-JAK inhibitors, female sex, PsA, CV disease, prior targeted biological and synthetic disease-modifying drugs exposure, and leflunomide co-treatment increased the risk of discontinuation. Pan-JAK inhibitors may have higher discontinuation rates than JAK1-selective inhibitors in real-world CIA patients. Clinical characteristics and comorbidities should guide JAKi selection to optimize long-term treatment retention."

Journal • Real-world evidence • Ankylosing Spondylitis • Cardiovascular • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • JAK1

High MDR1 expression in rheumatoid arthritis is associated with increased MMP-3 levels and use of bDMARDs: potential independence of JAK inhibitors from MDR1. (PubMed, Rheumatology (Oxford)) - "High MDR1 expression correlates with elevated MMP-3 levels and more frequent bDMARDs use. JAK inhibitors remain effective regardless of MDR1 status, potentially bypassing MDR1-mediated cellular drug resistance in RA."

Journal • Immunology • Inflammatory Arthritis • Orthopedics • Pain • Rheumatoid Arthritis • Rheumatology • ABCB1 • ICAM1 • MMP1 • MMP3

Drug retention rate of Janus kinase inhibitors in patients with rheumatoid arthritis: the KEIO-RA cohort study. (PubMed, Immunol Med) - "Full-dose JAKi use and concomitant methotrexate (MTX) use were associated with higher retention rates (p < 0.001 and p = 0.03, respectively). When comparing retention across five JAKi formulations among patients receiving full-dose JAKi with concomitant MTX, upadacitinib and filgotinib showed significantly lower discontinuation rates due to lack of efficacy (p = 0.04), whereas baricitinib had a lower discontinuation rate due to safety issues (p = 0.01). In conclusion, combination therapy with full-dose JAKi and MTX showed higher retention in this cohort."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Systematic Review and Network Meta-Analysis: Evaluating the Impact of advanced therapies for Moderate-to-Severe Ulcerative Colitis on Health-Related Quality of Life. (PubMed, J Crohns Colitis) - "Advanced therapies vary in their impact on HRQoL, with some demonstrating clinically meaningful improvements in UC. These findings support integrating HRQoL into treatment selection and shared decision-making."

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

Efficacy and safety of filgotinib in the treatment of ulcerative colitis with a focus on rapid and sustained efficacy: a narrative review. (PubMed, Intest Res) - "Safety outcomes indicated that FIL was well tolerated with no unexpected safety signals in SELECTION and SELECTIONLTE. These findings support FIL's potential as a robust therapeutic option for UC, due to its acceptable safety profile and benefits across clinical and HRQoL outcomes."

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

Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective. (PubMed, Intest Res) - "Regarding safety, particular attention has been given to risks such as herpes zoster infection and drug-induced acne, underscoring the importance of appropriate patient education and individualized risk assessment. This review summarizes clinical trials and current real-world data on tofacitinib, filgotinib, and upadacitinib in ulcerative colitis, and discusses strategies for optimizing their clinical application."

Journal • Real-world evidence • Review • Acne Vulgaris • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster

Characterizing the Use of Janus Kinase Inhibitors (JAKi) in Five European Countries: A Drug Utilization Study (ISPOR-EU 2025) - "Annual incidence rates of JAKi prescribing (abrocitinib, baricitinib, filgotinib, tofacitinib, upadacitinib) were estimated. Tofacitinib was the most initiated JAKi whilst abrocitinib was the least. Incidence of JAKi use increased from 2017 to 2023. Except for abrocitinib, most JAKi initiators were aged 41-60."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

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 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

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

Effect of JAK Inhibitors on Osteoblast Differentiation (ACR Convergence 2025) - "This study investigates the effects of different JAK inhibitors on osteoblast differentiation using an in vitro model. To assess the impact of JAK inhibitors on osteoblast differentiation, mouse MC3T3-E1 pre-osteoblast cells were cultured in the presence of various JAK inhibitors, specifically Baricitinib (Bari), Peficitinib (Pefi), and Filgotinib (Filgo). These findings indicate that JAK inhibitors exert differential effects on osteoblast differentiation. Bari and Pefi demonstrated inhibitory activity, whereas Filgo did not affect osteoblast maturation. Furthermore, the regulation of FOXM1 expression by JAK signaling suggests a possible mechanistic link to osteoblast differentiation, warranting further investigation into its role in bone remodeling and therapeutic implications for RA treatment."

Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • FOXM1

Efficacy and safety profile of JAK inhibitors in current practice in rheumatoid arthritis (ACR Convergence 2025) - "This decrease in DAS28-CRP appears to be numerically greater with the more selective JAKi (Upadacitinib, Filgotinib) than with Baricitinib and Tofacitinib.During the follow-up period, 45 patients (42%) discontinued JAKi (including 16 patients on Baricitinib, 53%, 6 on Tofacitinib, 60%, 21 on Upadacitinib, 44% and 2 on filgotinib, 10%). The present study demonstrated that the therapeutic maintenance of JAKi in RA exhibited a relatively high rate of occurrence at 12 and 24 months. Primarily utilized as a third-line targeted therapy, JAKi has been demonstrated to significantly improve RA activity, yielding favorable outcomes. However, a considerable proportion of patients discontinued treatment due to lack of efficacy or adverse effects, underscoring the necessity for ongoing, personalized evaluation of these therapies in routine clinical practice."

Clinical • Breast Cancer • Immunology • Inflammatory Arthritis • Myocardial Infarction • Pulmonary Embolism • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Solid Tumor

Real-World Experience of Janus Kinase Inhibitors; Retention and Factors Associated with Discontinuation (ACR Convergence 2025) - "Our aim was to investigate the place in treatment pathway, retention and factors associated with discontinuation of JAKi prescribed for RA and PsA in routine care. A retrospective review of all patients treated with Baricitinib (B), Filgotinib (F), Tofacitinib (T) and Upadacitinib (U) in 6 centres was conducted from time of first use of any of these agents in routine care until November 2024. JAKi are generally used late in the DMARD treatment pathway in routine care, with high retention rates and a CS sparing effect was evident. Significantly higher risks for discontinuation were female sex, older age, Bari versus Tofa treatment, and in RA patients use without MTX. The place in treatment pathway conferred no effect on retention."

Clinical • Real-world • Real-world evidence • Respiratory Diseases • Rheumatoid Arthritis