Abstract
The Janus kinase 1 inhibitor filgotinib had no measurable effect on semen parameters or sex hormones in men in the phase 2, double-blind, randomised MANTA and MANTA-RAy studies. Walter Reinisch and colleagues randomly assigned 248 men aged 21–65 years with active inflammatory bowel disease or inflammatory rheumatic diseases to receive filgotinib 200 mg once daily or placebo for 13 weeks. Eight (6·7%) of 120 patients receiving filgotinib had a 50% or greater decrease in sperm concentration from baseline to week 13 (the primary outcome) compared with ten (8·3%) of 120 receiving placebo (difference −1·7%; 95% CI −9·3 to 5·8). No clinically relevant changes in semen parameters or sex hormones were seen between treatment groups. Adverse events were similar to those reported in other trials of filgotinib.
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