Filgotinib Effects on Semen and Sex Hormones Save
The oral Janus kinase 1 inhibitor filgotinib is available worldwide, but not in the USA, where the FDA held up its approval for use in RA due to unfinished studies of filgotinib's effects on sperm cells. The results of 2 phase two studies (MANTA and MANTA-RAy) confirm that filgotinib has no measurable impact on semen parameters or sex hormones in men with active IBD or inflammatory rheumatic diseases.
MANTA and MANTA-RAy trials enrolled men (21–65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases (RA, AS, PsA). With filgotinib treatment for 13 weeks serial semen parameters were assessed.
A total of 248 patients received either filgotinib 200 mg or placebo. The primary endpoint was the number of patients with a ≥50% decrease from baseline in sperm concentration at week 13; this was achieved in 6.7% on FIL and 8.3% on PBO. No clinically relevant changes were seen in semen parameters or sex hormones over this 13 week study.
Standard doses of filgotinib 200 had no measurable impact on semen parameters or sex hormones.
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