Rozanolixizumab falls flat in severe fibromyalgia trial

Rozanolixizumab shows no evidence of benefit in patients with severe fibromyalgia in a phase IIa study.

The study consisted of a screening period, a 2-week single-blind placebo run-in period, two subsequent 12-week double-blind treatment periods, a 2-week single-blind placebo run-out period, and a 5-week safety follow-up.

A total 63 adult patients (median age 47 years, 87 percent female, 95 percent White) with severe fibromyalgia, defined as a Brief Pain Inventory-Short Form (BPI-SF) interference score of ≥6 and 10-day mean daily Pain Numeric Rating Scale score of ≥6 to <10, participated in the study.

The patients were randomly assigned to once-weekly treatment with rozanolixizumab 560 mg for 24 weeks (rozanolixizumab–rozanolixizumab; n=22), placebo for 12 weeks then rozanolixizumab for 12 weeks (placebo–rozanolixizumab; n=20), or placebo for 24 weeks (placebo–placebo; n=21). Treatment was administered via subcutaneous infusion.

The primary endpoint of change in BPI-SF interference score from baseline to 12 weeks met the prespecified one-sided 10-percent α level, with greater improvement observed with rozanolixizumab vs placebo (least squares mean difference, –0.5, 80 percent confidence interval [CI], –1.0 to –0.1; p=0.065). However, the difference did not reach significance at a two-sided 5-percent α level (least squares mean difference, –0.5, 95 percent CI, −1.2 to 0.2; p=0.13).

In terms of safety, the most common treatment-emergent adverse event (TEAE) was headache, occurring in 41 percent and 30 percent of patients receiving rozanolixizumab vs 41 percent and 15 percent of those receiving placebo in the first 12 weeks and second 12 weeks of double-blind treatment, respectively.

There were no serious TEAEs documented among patients receiving rozanolixizumab.