Treatment with bimekizumab for patients with moderate-to-severe plaque psoriasis showed significant positive results and clinical outcomes in a phase 3 study.
Plaque psoriasis is a chronic inflammatory illness mediated by the immune system. It causes large skin lesions that can be scaly, thick, and, at times, pruritic. This substantial illness burden influences patients’ quality of life (QOL). Psoriasis is associated with a higher risk of comorbidities. Interleukin (IL)-17A and IL-17F are overexpressed in psoriatic skin lesions, contributing to the development of psoriasis and psoriatic arthritis.
Bimekizumab, a humanized monoclonal immunoglobulin G1 antibody, targets IL-17A and IL-17F and inhibits downstream signaling. In four phase 3/3b clinical trials, bimekizumab outperformed placebo, adalimumab, secukinumab, and ustekinumab in individuals with moderate-to-severe plaque psoriasis.
This phase 3, randomized, double-blinded, ustekinumab- and placebo-controlled, multicenter study of bimekizumab was published in the journal Dermatology and Therapy.
Bimekizumab Superior to Ustekinumab and Placebo
Bimekizumab exhibited a higher degree of effectiveness in alleviating psoriasis symptoms compared to ustekinumab and placebo. A greater proportion of patients undergoing treatment with bimekizumab at week 16 attained a Psoriasis Area and Severity Index (PASI) score of 90 and an Investigator’s Global Assessment (IGA) score of 0/1 compared to those who received ustekinumab and placebo. At week 16, bimekizumab treatment exhibited a higher frequency of complete skin clearance, i.e., patients with Psoriasis Area and Severity Index (PASI) values of 100 (PASI 100), compared to ustekinumab and placebo.
Bimekizumab Showed Rapid and Persistent Efficacy and Higher Response Rates
Bimekizumab demonstrated rapid and consistent effectiveness, with increased response rates seen as early as week 4. Bimekizumab demonstrated greater efficacy compared to ustekinumab in achieving PASI 90 and IGA 0/1 up to week 52. Patients who switched from placebo to bimekizumab at week 16 showed comparable effectiveness results to those who were initially treated with bimekizumab. By week 16, a higher number of individuals treated with bimekizumab reached PASI 100 and Investigator’s Global Assessment (IGA) scores of 0 compared to those treated with ustekinumab and placebo. More patients treated with bimekizumab reached absolute PASI thresholds at week 16 compared to those treated with ustekinumab and placebo. At week 52, these absolute PASI responses were maintained or improved.
Enhanced Quality of Life
Patients receiving bimekizumab exhibited notable improvements in their QoL compared to those treated with ustekinumab or placebo. By week 16, a significantly larger percentage of bimekizumab-treated patients reported a Dermatology Life Quality Index (DLQI) score of 0/1, indicating minimal to no impact of psoriasis on their daily lives, in contrast to ustekinumab and placebo recipients. Moreover, bimekizumab showed better results in improving pain item scores compared to patients treated with ustekinumab.
Adverse Events Similar Across Groups
All treatment groups had similar treatment-emergent adverse events (TEAEs) in the first 16 weeks. Adverse events were observed in 64.5% of patients treated with bimekizumab, 58.6% of those treated with ustekinumab, and 41.2% of those treated with placebo. Serious adverse events were rare, occurring in 1.6% of patients treated with bimekizumab and 3.4% of those treated with ustekinumab, with no cases in the placebo group.
During the entire study period, from week 0 to week 52, adverse events occurred in 84.4% of patients who received bimekizumab and 79.3% of those who received ustekinumab. Bimekizumab was associated with more treatment-related adverse events (42.9%) than ustekinumab (27.6%). Nasopharyngitis, oral candidiasis, and eczema were common side effects of bimekizumab.
Source:
Asahina, A., Okubo, Y., Morita, A., Tada, Y., Igarashi, A., Langley, R., Deherder, D., Matano, M., Vanvoorden, V., Wang, M., Ohtsuki, M., & Nakagawa, H. (2023). Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatology and Therapy, 13(3), 751–768. https://doi.org/10.1007/s13555-022-00883-y
