Bimekizumab sustains effectiveness in psoriatic arthritis over 52 weeks
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Key takeaways:
- Bimekizumab demonstrated sustained efficacy between 16 and 52 weeks of treatment in patients with psoriatic arthritis.
- Candida infection occurred in 7.7% of patients receiving bimekizumab.
Bimekizumab remains effective after 52 weeks in patients with psoriatic arthritis, with no new safety concerns, according to data published in Annals of the Rheumatic Diseases.
“Psoriatic arthritis is a chronic, long-term disease, therefore treatment options that provide inflammation control and long-term, durable efficacy and tolerability are needed,” Christopher T. Ritchlin, MD, MPH, of the University of Rochester Medical School, and colleagues wrote. “... Data from BE OPTIMAL to week 24 were reported in the primary manuscript. Here, we report the long-term clinical efficacy and safety of subcutaneous [bimekizumab (BKZ)] 160 mg every 4weeks in adult, [biologic disease-modifying antirheumatic drug (bDMARD)]-naïve patients with active PsA to 52 weeks: the final results of the phase III BE OPTIMAL study.”
To assess the long-term efficacy and safety of bimekizumab (Bimzelx, UCB) in biologic DMARD-naïve patients with active PsA, Ritchlin and colleagues conducted the randomized, placebo-controlled BE OPTIMAL study. Participants were randomly selected to receive either 160 mg of subcutaneous bimekizumab every 4 weeks, subcutaneous placebo every 2 weeks or 40 mg of subcutaneous adalimumab (Humira, Abbvie) every 2 weeks. After 16 weeks, patients who were receiving placebo switched to receiving 160 mg of bimekizumab every 4 weeks through the rest of the trial. Patients receiving bimekizumab or adalimumab continued their dosing through week 52.
Initially, 852 patients were randomly assigned treatment, while 770 patients participated for 52 weeks. Researchers used ACR20, ACR50 and ACR70 response rates to determine efficacy of the treatments.
After 16 weeks, 43.9% of patients treated with bimekizumab achieved ACR50 response, compared with 45.7% of those treated with adalimumab and 10% of those in the placebo group, according to the researchers. After 52 weeks, 54.5% of patients treated with bimekizumab achieved ACR50, compared with 50% of patients treated with adalimumab. Among the patients who switched from placebo to bimekizumab after 16 weeks, 53% achieved ACR50 by week 52.
In the 52-week period, 79.1% of patients receiving bimekizumab reported having one or more treatment-emergent adverse events, compared with 80.7% of those receiving adalimumab. Candida infection occurred in 7.7%, of patients receiving bimekizumab compared with 0.7%, of those treated with adalimumab.
“Dual inhibition of IL-17A and IL-17F with BKZ in bDMARD-naïve patients with active PsA resulted in sustained long-term, clinically meaningful improvements across the PsA disease domains, determined using stringent efficacy measures,” Ritchlin and colleagues wrote. “Efficacy on BKZ treatment was sustained from week 16 to week 52 in patients initially randomized to BKZ; patients who switched from [placebo (PBO)] to BKZ at week 16 achieved similar levels of efficacy at week 52 to patients initially randomized to BKZ.
“BKZ was well tolerated and the safety profile was consistent with prior studies,” they added. “Long-term safety and efficacy data will be assessed in the ongoing OLE study, BE VITAL.
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