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

Efficacy and Safety of Upadacitinib in Moderate-to-Severe IBD: A Systematic Review of RCTs in Biologic-Naïve and Biologic-Experienced Populations (ACG 2026) - "Introduction: Upadacitinib (UPA),an oral selective Janus kinase 1 (JAK-1) inhibitor,has emerged as an important therapy for inflammatory bowel disease (IBD).There is a lack of evidence synthesizing its comparative efficacy in biologic-naiÌve versus biologic- experienced (Bio-IR) patients across both Ulcerative Colitis (UC) and Crohnâs Disease (CD).This systematic review evaluates the efficacy, safety, and dose-response relationship of UPA in moderate-to-severe IBD. Five RCTs were included.UPA 45 mg induction therapy showed superior clinical and endoscopic remission rates compared to placebo. In maintenance phases, biologic-naiÌve patients attained the highest remission rates (up to 64.0% in UC and 58.5% in CD at week 52).UPA showed a clinically significant rate of remission of 42% in Bio-IR patients, indicating it may overcome the âceiling effectâ of traditional biologics.The safety analysis demonstrated a dose-dependent increase of adverse..."

Clinical • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • Varicella Zoster • IL23A • JAK1

Sustained Clinical and Endoscopic Improvements With up to 3 Years of Risankizumab Maintenance Treatment in Patients With Moderate to Severe Ulcerative Colitis Regardless of the Number of Prior Advanced Therapy Exposures (ACG 2026) - "AT included approved biologics for UC (infliximab, adalimumab, golimumab, ustekinumab, and/or vedolizumab), approved Janus kinase inhibitors for UC (tofacitinib, filgotinib, upadacitinib), and/or ozanimod. At induction baseline, among the 1003 pts included in the AO analysis, 29.4% (N=295) were AT-naïve; 29.4% (N=295) and 41.2% (N=418) had previously experienced 1 and >1 AT, respectively. Among the RZB180 and RZB360 groups, rates of CR (per AMS or PAMS) generally remained stable at OLE W0 and 96, regardless of the number of prior AT exposures, per AO analysis. Rates of endoscopic improvement and remission were sustained, regardless of the number of prior AT exposures, per AO analysis."

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

Comparative Efficacy and Safety of Etrasimod Versus Ozanimod, JAK Inhibitors, and Placebo in Adults With Moderate to Severe Ulcerative Colitis (ACG 2026) - "Regarding safety, filgotinib 100 mg was the only treatment significantly reducing any-TEAE risk versus placebo (OR 0.82; 95% CrI 0.68-0.98), while ozanimod 1 mg was the only treatment significantly increasing TEAE risk (OR 1.71; 95% CrI 1.22-2.40). Up to 28 RCTs enrolling 8,377 participants were included. For induction clinical remission (18 RCTs; N=6,562), upadacitinib 45 mg ranked highest (OR 9.92, 95% CrI 5.81-18.11; SUCRA 90%), followed by ozanimod 1 mg (OR 4.37; SUCRA 63%), tofacitinib 10 mg induction (OR 4.23; SUCRA 60%), and etrasimod 2 mg (OR 3.61; SUCRA 52%). For induction clinical response, upadacitinib 45 mg again ranked first (OR 7.84; SUCRA 94%), with etrasimod 2 mg (OR 3.01; SUCRA 59%) and tofacitinib 10 mg (OR 2.96; SUCRA 58%) performing comparably."

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

Real-World Cardiovascular Outcomes Following Janus Kinase and IL-23p19 Inhibitor Therapy in Inflammatory Bowel Disease (ACG 2026) - "Adults with Crohnâs disease or ulcerative colitis who initiated a JAK inhibitor (tofacitinib, upadacitinib, or filgotinib) or an IL-23p19 inhibitor (risankizumab, mirikizumab, or guselkumab) within three years of IBD diagnosis were identified. Before matching, 11,998 patients received JAK inhibitors and 13,239 received IL-23p19 inhibitors. After matching, 11,206 patients remained in each cohort with balanced baseline characteristics. Compared with IL-23p19 inhibitors, JAK inhibitor therapy was associated with a higher risk of all-cause mortality (0.6% vs 0.4%; RR 1.75, 95% CI 1.19â2.58; p=0.004), MACE (1.2% vs 0.9%; RR 1.33, 95% CI 1.03â1.73; p=0.029), MI (0.6% vs 0.4%; RR 1.51, 95% CI 1.02â2.24; p=0.038), and VTE (1.9% vs 1.5%; RR 1.27, 95% CI 1.04â1.56; p=0.019)."

Clinical • Real-world • Real-world evidence • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Inflammation • Inflammatory Bowel Disease • Myocardial Infarction • Ulcerative Colitis • Venous Thromboembolism

Risk of Diverticulitis in Rheumatoid Arthritis Patients Treated With IL-6 Inhibitors Versus JAK Inhibitors: A Real-World Propensity-Matched Study (ACG 2026) - "Two mutually exclusive cohorts were defined: IL-6 inhibitor users (tocilizumab, sarilumab, siltuximab) without JAK inhibitor exposure, and JAK inhibitor users (tofacitinib, baricitinib, upadacitinib, filgotinib) without IL-6 exposure...Outcomes were assessed at 5 years, 10 years, and all follow-up after 1:1 propensity score matching for age, sex, diabetes, obesity, tobacco use, prior diverticular disease, alcohol-related disorders, NSAID, glucocorticoid, and methotrexate use... After matching, 10,459 patients remained per cohort, well-balanced (all standardized differences < =0.04). At 5 years, diverticulitis occurred in 160 IL-6 patients (1.6%) versus 146 JAK patients (1.4%): RR 1.092 (95% CI 0.874-1.365), p=0.436; HR 1.196 (0.955-1.497). At 10 years, 192 (1.9%) versus 172 (1.7%): RR 1.113 (0.907-1.365), p=0.304; HR 1.182 (0.962-1.453)."

Clinical • Real-world • Real-world evidence • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Obesity • Rheumatoid Arthritis • Rheumatology

Drug Similarity Network Model for Personalized Biologic Sequencing in Inflammatory Bowel Disease - A Novel Undirected Weighted Similarity-Graph Framework (ACG 2026) - "Eight therapeutic classes were represented as network nodes: anti-TNF agents (infliximab, adalimumab), vedolizumab, ustekinumab, risankizumab, mirikizumab, ozanimod, and JAK inhibitors (tofacitinib, filgotinib), with similarity metrics derived from clinical remission, endoscopic healing, biomarker normalization, and safety outcomes. The calibrated network identified ustekinumab as a key bridging therapy after anti-TNF failure in Crohn's disease (CD). Key similarity scores included: vedolizumab-anti-TNF (0.68), ustekinumab-risankizumab (0.78), ustekinumab-vedolizumab (0.72), and anti-TNF-ozanimod (0.55). In anti-TNF-experienced CD, the model prioritized risankizumab over ustekinumab, consistent with SEQUENCE trial findings (endoscopic remission at week 48: 31.8% vs 16.2%, p< 0.0001)."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Effect of JAK Inhibitors on Fatigue and Sleep Quality in Patients with Rheumatoid Arthritis: A Narrative Review. (PubMed, J Clin Med) - "An analysis of available study results showed that baricitinib, filgotinib, tofacitinib and upadacitinib reduce fatigue severity. For upadacitinib, an improvement in sleep quality appeared to be associated with disease control and remission. The smaller number of studies on sleep quality than on fatigue highlights the need to consider this parameter more thoroughly when assessing the efficacy of JAKi treatment and emphasises the importance of a more holistic approach in clinical practice."

Journal • Review • CNS Disorders • Fatigue • Immunology • Inflammation • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology • Sleep Disorder

Risks of breast or prostate cancer recurrence and a second cancer in patients with inflammatory arthritis following treatment with biologic and targeted synthetic DMARDs - A nationwide cohort study (EULAR 2026) - "Eligible drugs included all five TNFi, non-TNFi bDMARDs (abatacept, rituximab, sarilumab, tocilizumab (for RA), sekukinumab, ixekizumab, bimekizumab (for SpA/PsA), and tsDMARDs, that is JAK inhibitors (baricitinib, filgotinib, tofacitinib, upadacitinib). The corresponding analyses of non-TNFi-bDMARDs, and in particular tsDMARDs, were limited by few events. The findings are clinically reassuring, supporting the safety of TNFi when treating IA in patients with a prior breast or prostate cancer."

Clinical • Ankylosing Spondylitis • Breast Cancer • Genito-urinary Cancer • Immunology • Inflammatory Arthritis • Oncology • Prostate Cancer • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • Spondylarthritis

JAK inhibitors and adverse cardiovascular events: Class effect or molecule-specific risk? (PubMed, Front Pharmacol) - "Randomized trials, observational studies, and pharmacovigilance analyses involving tofacitinib, baricitinib, upadacitinib, and filgotinib have produced heterogeneous findings, with no consistent replication of a uniform class-wide cardiovascular signal. Mechanistic plausibility exists for both hypotheses through shared JAK-STAT pathway effects on vascular inflammation and thrombosis. This narrative review synthesizes current evidence from clinical trials, real-world data, and regulatory perspectives to critically assess the available evidence regarding whether cardiovascular risk represents a class effect or a molecule-specific phenomenon."

Adverse events • Journal • Review • Cardiovascular • Hematological Disorders • Immunology • Inflammatory Arthritis • Myocardial Infarction • Oncology • Rheumatoid Arthritis • Rheumatology • Thrombosis

Cancer Risk with Janus Kinase Inhibitors: Drug-Specific Risks or a Class Effect? A systematic literature review and network meta-analysis across Immune Mediated Inflammatory Diseases (ACR Convergence 2026) - "Eligible comparators were placebo (PBO) and/or methotrexate monotherapy (MTX) or another active comparator. Models allowing treatment-specific JAKi effects provided a better fit than a common class-effect model. While tofacitinib was associated with increased cancer risk relative to TNFi, similar associations were not observed for baricitinib, upadacitinib, or filgotinib. These findings suggest that malignancy risk may vary between JAKi and should not necessarily be assumed to represent a uniform class effect."

Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

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

Biologic drugs for induction and maintenance of remission in Crohn's disease: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "This review has supported evidence generation, but head-to-head comparative trials for key interventional subclasses or specific agents may be needed, as guided by key stakeholders; for example, on the use of biosimilar versions of medications out of patent. The role of concomitant purine analogues is a key confounding factor and future studies may not only want to investigate specifically the role of combinations, but also consider stratifying populations or purposefully excluding participants based on this key class of therapy to avoid such heterogeneity. Given the majority of evidence focusses on the outcomes of clinical remission and relapse, future studies may want to further consider other outcomes of clear interest to clinicians and patients, particularly endoscopic remission. Finally, long-term safety data are limited throughout the networks. Whilst future studies with longer follow-ups could provide increased data, it may be that study designs outside of..."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL7R

Effectiveness and retention of certolizumab pegol and JAK inhibitors in rheumatoid arthritis: a multicenter retrospective study stratified by rheumatoid factor status. (PubMed, Front Med (Lausanne)) - "This multicentre retrospective cohort included RA patients initiating CZP or JAKi (baricitinib, filgotinib, tofacitinib, upadacitinib) between 2010 and 2024. A numerical difference in treatment retention favouring CZP was also observed. These findings highlight the potential importance of considering RF levels when selecting treatment and warrant further investigation in prospective studies."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Risk of Malignant Melanoma with biologic- or targeted synthetic disease-modifying therapies in patients with rheumatoid arthritis: a Swedish Nationwide Cohort Study (EULAR 2026) - "Exposures were categorized as (i) JAKi (baricitinib, filgotinib, upadacitinib, tofacitinib), (ii) non-TNFi (abatacept, rituximab, sarilumab, tocilizumab), and (iii) TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab). However, for both drug classes there were signals of an internal shift in the distribution of invasive (approximately 1 extra annual case for every 2000 patients) vs. in situ MM (approximately 1 fewer annual case for every 2000 patients). Abatacept was associated with an increased risk of MM overall."

Clinical • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Genetic Disorders • Heart Failure • Immune Modulation • Immunology • Infectious Disease • Inflammatory Arthritis • Melanoma • Metabolic Disorders • Nephrology • Non-melanoma Skin Cancer • Pulmonary Disease • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Skin Cancer • Solid Organ Transplantation • Solid Tumor

SELECTIONLTE: Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis (clinicaltrials.gov) - P3 | N=1173 | Completed | Sponsor: Alfasigma S.p.A. | Active, not recruiting ➔ Completed

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

Long-Term Persistence, Effectiveness and Safety of Filgotinib in Rheumatoid Arthritis: A Multicenter Real-World Study from Three Spanish Cohorts (ACR Convergence 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

STARTER: FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial (clinicaltrials.gov) - P4 | N=240 | Not yet recruiting | Sponsor: University Hospital, Clermont-Ferrand | Initiation date: Jun 2026 ➔ Dec 2026

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

ANTI-FIBROTIC EFFECTS INDUCED BY FILGOTINIB IN ULCERATIVE COLITIS PATIENTS DETECTED BY MOLECULAR ANALYSIS AND FAPI PET/CT: THE INTERACT TRIAL (UEGW 2026) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

JAK Inhibitors for Refractory Non-Infectious Ocular Inflammation: A Systematic Review and Meta-Analysis of Efficacy, Safety, and Optimal Positioning. (PubMed, Ocul Immunol Inflamm) - "Systemic JAK inhibitors show a consistent favorable direction in refractory intraocular inflammation, most reliably filgotinib, but heterogeneity and very low certainty preclude pooling. They may serve as third- or fourth-line agents pending Phase 3 data."

Journal • Retrospective data • Review • Cardiovascular • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Scleritis • Uveitis

Incidence of Uveitis in Patients With Axial Spondyloarthritis Receiving Filgotinib in the TORTUGA and OLINGUITO Trials (ACR Convergence 2026) - No abstract available

Clinical • Ankylosing Spondylitis • Immunology • Ocular Inflammation • Ophthalmology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis

CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca (filgotinib), Treatment of Adults With Axial Spondyloarthritis (Businesswire) - "The positive opinion is based on data from the OLINGUITO Phase 3 trial..."

CHMP • Immunology • Spondylarthritis

Efficacy and tolerability of janus kinase inhibition strategies for moderate-to-severe Crohn's disease: A systematic review and bayesian network meta-analysis. (PubMed, Ther Adv Gastroenterol) - "The network evaluated upadacitinib across six dosing regimens and filgotinib across two. However, the evidence network was sparse, limiting the clinical applicability. Treatment rankings should therefore be interpreted as exploratory."

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

Factors associated with the effectiveness and safety of Janus kinase inhibitors in rheumatoid arthritis: an 8-year observational study from the JAGUAR Registry. (PubMed, RMD Open) - "In RA, chronic concomitant GC treatment and patient age are associated with JAK inhibitor discontinuation due to lack of effectiveness and ADRs, respectively."

Journal • Observational data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Influence of Ageing on the Pharmacology, Efficacy and Safety of Oral Targeted Therapies for Inflammatory Bowel Disease: Focus on Janus Kinase (JAK) Inhibitors and Sphingosine-1-Phosphate (S1P) Receptor Modulators. (PubMed, Drugs Aging) - "This review synthesises the available evidence on the influence of ageing on the pharmacology, efficacy and safety of orally administered targeted inflammatory bowel disease therapies, focusing on registered Janus kinase inhibitors (tofacitinib, upadacitinib, filgotinib) and sphingosine-1-phosphate receptor modulators (ozanimod, etrasimod). There is, however, no clear consensus on how ageing-related vulnerability, including frailty and comorbidity burden, should be defined, measured, and reported across studies, which complicates the interpretation and comparison of outcomes. In the absence of robust outcome data for older adults with inflammatory bowel disease, treatment selection should be guided by biological vulnerability (frailty, organ function, comorbidity burden) and structured risk-mitigation strategies, while future research should prioritise age- and frailty-enriched prospective studies with geriatric-relevant outcomes and long-term pharmacovigilance."

Journal • Review • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology

Effect of JAK inhibitors on extraintestinal manifestations and concurrent immune-mediated inflammatory diseases in patients with inflammatory bowel disease. (PubMed, J Crohns Colitis) - "JAK inhibitors were associated with favorable physician-assessed outcomes for EIMs/IMIDs in treatment-experienced IBD patients. Co-existing axial and peripheral SpA was associated with treatment discontinuation, suggesting a more complex phenotype."

Journal • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis