Bimekizumab Shows Persistent Efficacy, Safety in Psoriatic Arthritis at 52 Weeks

In patients with psoriatic arthritis, bimekizumab showed sustained, consistent effectiveness to 52 weeks with or without methotrexate, according to a post hoc analysis of the BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), and BE VITAL (NCT04009499) trials.¹ The findings were published in ACR Open Rheumatology, the journal of the American College of Rheumatology.

The BE OPTIMAL study assessed bimekizumab in patients naïve to biologic disease-modifying antirheumatic drugs (DMARDs),² BE COMPLETE assessed bimekizumab in patients with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi),³ and BE VITAL was an open-label extension study of BE COMPLETE.⁴

The new analysis aimed to assess the efficacy and safety of bimekizumab among patients with active psoriatic arthritis based on the achievement of American College of Rheumatology 50% (ACR50) response criteria.¹

Bimekizumab showed sustained, consistent effectiveness to 52 weeks with or without methotrexate in psoriatic arthritis. | Image credit: stockdevil - stock.adobe.com

Of 712 patients receiving bimekizumab in BE OPTIMAL, 415 (58.3%) were also receiving methotrexate, 297 (41.7%) were not receiving methotrexate. A total of 645 (90.6%) patients completed bimekizumab treatment through week 52, with 383 also receiving methotrexate and 262 not receiving methotrexate. Of 400 patients receiving bimekizumab in BE COMPLETE (170 [42.5%] on concurrent methotrexate and 230 [57.5%] not on methotrexate), 388 completed week 16 and 377 (94.3%) entered the BE VITAL open-label extension trial and 347 (86.8%) completed treatment to week 52. Among these patients, 156 (91.8%) were receiving methotrexate and 191 (83.0%) were not.

In both BE OPTIMAL and BE COMPLETE, patients treated with bimekizumab showed improvements across all measured psoriatic arthritis domains, including those related to joints and skin. Patients receiving bimekizumab with or without methotrexate had similar rates of response based on ACR50 response criteria at week 52. In BE OPTIMAL, 54.4% in the methotrexate group and 54.7% in the non-methotrexate group achieved ACR50 responses. In BE COMPLETE, 56.3% and 48.0% of patients on methotrexate and not on methotrexate, respectively, experienced ACR50 responses.

Complete skin clearance, defined as Psoriasis Area and Severity Index 100% (PASI100) response, occurred in similar proportions of patients treated with bimekizumab with and without methotrexate (61.1% and 60.4%, respectively, in BE OPTIMAL; 68.8% and 63.5%, respectively, in BE COMPLETE). Across groups in both studies, the proportions of patients who experienced PASI100 after switching to bimekizumab from placebo at week 16 notably increased to week 52. Similar trends were also seen regarding minimal disease activity.

Regarding safety, similar proportions of patients receiving bimekizumab with and without methotrexate experienced at least one treatment-emergent adverse event (TEAE). Most TEAEs were mild or moderate in both studies.

“Bimekizumab demonstrated efficacy in joints, skin, and composite outcomes, with similar results across studies, indicating effectiveness irrespective of patients’ prior biologic treatment,” the authors wrote. “Similar results across these patient populations are of clinical interest because TNFi-IR [inadequate response] patients are typically more difficult to treat, cycle through therapies with varying mechanisms of action more quickly than patients who are tolerant to TNFi, and have reduced response rates overall.”

The authors noted several limitations, including the post hoc nature of the analysis, which did not allow for assessment of the benefit of methotrexate plus bimekizumab. Due to safety results being reported with descriptive analysis from the trials, it was also not possible to detect significant differences in safety events, the authors noted. Future studies will also report on longer-term data.

“In conclusion, treatment with bimekizumab demonstrated consistent, sustained clinical efficacy to 52 weeks in [biologic] DMARD-naive and TNFi-IR patients with active psoriatic arthritis, irrespective of concomitant methotrexate administration,” the authors wrote. “Results were similar between the BE OPTIMAL and BE COMPLETE study populations, and bimekizumab was well tolerated in patients with psoriatic arthritis in both [methotrexate] and [non- methotrexate] groups.”

References

1. McInnes IB, Mease PJ, Tanaka Y, et al. Efficacy and safety of bimekizumab in patients with psoriatic arthritis with or without methotrexate: 52-week results from two phase 3 studies. ACR Open Rheumatol. Published online July 30, 2024. doi:10.1002/acr2.11727

2. A study to test the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE OPTIMAL). ClinicalTrials.gov. Updated April 4, 2024. Accessed August 22, 2024. https://clinicaltrials.gov/study/NCT03895203

3. A study to evaluate the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE COMPLETE). ClinicalTrials.gov. Updated April 4, 2024. Accessed August 22, 2024. https://clinicaltrials.gov/study/NCT03896581

4. A study to assess the long-term safety, tolerability, and efficacy of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE VITAL). ClinicalTrials.gov. Updated August 2, 2024. Accessed August 22, 2024. https://clinicaltrials.gov/study/NCT04009499