Trial reportAnnals of the rheumatic diseases2023
Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies.
Trial report in Annals of the rheumatic diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Who cites it
19 citing papers in PubMed, 37 citations in OpenAlex.
- Urate-lowering agents do not have clinically relevant negative effects on sperm quality and reproductive hormones in men with gout: a prospective open-label cohort study.Rheumatology international · 2024Trial
- Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies.Rheumatology and therapy · 2026Article
- Reversible azoospermia associated with the selective JAK1 inhibitor abrocitinib: a case report.Journal of assisted reproduction and genetics · 2026Article
- Risk-benefit considerations for antirheumatic drug use in pregnancy, breastfeeding, and male preconception: expert perspectives.EULAR rheumatology open · 2026Article
- Emerging therapeutic targets in non-infectious uveitis and scleritis.Frontiers in medicine · 2026Review
- Adverse effects of Janus kinase inhibitors with relevance for daily practice in dermatology.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025Review
- Janus kinase inhibitors: another potential for uveitis treatment?Annals of eye science · 2025Article
- JAK Inhibitors and Risk of Cancer in IBD Patients.Cancers · 2025Review
- A disproportionality analysis of FDA adverse event reporting system (FAERS) events for filgotinib.PloS one · 2025Article
- Efficacy and Safety of Janus Kinase-Inhibitors in Ulcerative Colitis.Journal of clinical medicine · 2024Review
- Navigating Reproductive Care in Patients With Inflammatory Bowel Disease: A Comprehensive Review.Journal of Crohn's & colitis · 2024Review
- Male Fertility in Spondyloarthritis: from Clinical Issues to Cytokines Milieu. A Narrative Review.Current rheumatology reports · 2024Review
- Efficacy and safety of JAK inhibitors in rheumatoid arthritis: update for the practising clinician.Nature reviews. Rheumatology · 2024Review
- Article
- Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024Review
- JAK inhibitors: an evidence-based choice of the most appropriate molecule.Frontiers in pharmacology · 2024Review
- Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel.Therapeutic advances in gastroenterology · 2024Article
- JAK inhibitors for inflammatory bowel disease: recent advances.Frontline gastroenterology · 2024Review
- Are All Janus Kinase Inhibitors for Inflammatory Bowel Disease the Same?Gastroenterology & hepatology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 13 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe phase 2 MANTA and MANTA-RAy studies aimed to determine if the oral Janus kinase 1 preferential inhibitor filgotinib affects semen parameters and sex hormones in men with inflammatory diseases.
methodsMANTA (NCT03201445) and MANTA-RAy (NCT03926195) included men (21-65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), respectively. Eligible participants had semen parameters in the normal range per the WHO definition. In each study, participants were randomised 1:1 to receive once-daily, double-blind filgotinib 200 mg or placebo for 13 weeks for pooled analysis of the primary endpoint (proportion of participants with a ≥50% decrease from baseline in sperm concentration at week 13). Participants who met the primary endpoint were monitored over an additional 52 weeks for 'reversibility'. Secondary endpoints included change from baseline to week 13 in: sperm concentration, total motility, normal morphology, total count and ejaculate volume. Sex hormones (luteinising hormone, follicle stimulating hormone, inhibin B and total testosterone) and reversibility were exploratory endpoints.
resultsAcross both studies, 631 patients were screened, and 248 were randomised to filgotinib 200 mg or placebo. Baseline demographics and characteristics were similar within indications between treatment groups. Numerically similar proportions of filgotinib-treated versus placebo-treated patients met the primary endpoint (8/120 (6.7%) vs 10/120 (8.3%)), Δ-1.7% (95% CI -9.3% to 5.8%)). There were no clinically relevant changes from baseline to week 13 in semen parameters or sex hormones, or patterns of reversibility between treatment groups. Filgotinib was well tolerated, with no new safety events.
conclusionsResults suggest that once daily filgotinib 200 mg for 13 weeks has no measurable impact on semen parameters or sex hormones in men with active IBD or inflammatory rheumatic diseases.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.