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
Primary result · ≥50% decrease from baseline in sperm concentrationResult — go to the resultΔ −1.7% 95% CI −9.3% to 5.8%Authors' conclusion
Results 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.
Study context
- Population
- Men (21–65 years) with active inflammatory bowel disease (IBD) (MANTA) or rheumatic diseases (RA, SpA or PsA; MANTA-RAy) and semen parameters in the WHO normal rangerandomised
- Participants
- 248 men
- Comparison
- Filgotinib 200 mg once daily vs placebo for 13 weeks
- Filgotinib 200 mgn = 120
- Placebon = 120reference
- Primary endpoint
- Proportion of participants with a ≥50% decrease from baseline in sperm concentration
- Follow-up
- Week 13
Methodological detailsphase 2, double-blind, placebo-controlled, pooled analysis of two studies (MANTA and MANTA-RAy), 1:1 randomisation
- Phase 2
- Double-blind
- Placebo-controlled
- Pooled analysis of two studies (MANTA and MANTA-RAy)
- 1:1 randomisation
Primary result
As reported in the abstract
≥50% decrease from baseline in sperm concentration
Δ
−1.7%
95% CI −9.3% to 5.8%
Events by treatment group
Filgotinib 200 mgvs Placebo
Δ −1.7% (95% CI −9.3% to 5.8%)
Secondary outcomes
Change in semen parameters and sex hormones, and patterns of reversibility · week 13
- No clinically relevant changes from baseline between treatment groups
Original publication
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. Ann Rheum Dis. Published 3 May 2023. doi:10.
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