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Secukinumab, a human monoclonal antibody that binds to and selectively neutralizes interleukin-17A, is associated with sustained efficacy over a 52-week period in patients with moderate to severe psoriasis, according to findings from a post-hoc analysis of 2 phase 3 clinical trials published in the British Journal of Dermatology.
The phase 3 randomized controlled trials FIXTURE and CLEAR (ClinicalTrials.gov identifier: NCT01358578 and NCT02074982, respectively) were used to obtain patient data for the analysis. In the FIXTURE trial, patients received 300 mg secukinumab (n=327) and etanercept (n=326), whereas in the CLEAR trial, participants received 300 mg secukinumab (n=336) and ustekinumab (n=339). Treatment was administered over a 52-week period. Responses were defined as excellent (≥PASI90), good (≥PASI75 and <PASI90), and insufficient (≤PASI75). Shifts from higher to lower response categories between 2 consecutive visits defined efficacy reduction.
In the CLEAR trial, the majority of patients who received secukinumab experienced stable efficacy without loss at 52-week follow-up (90.2%). Additionally, up to 77.7% of patients achieved stable efficacy without any response reduction; for ustekinumab these outcomes were achieved in 74.3% and 59.9% of patients, respectively. Stable efficacy without loss or reduction of response was also achieved in 83.5% and 66.4% of patients who received secukinumab vs 58.3% and 42.6% for etanercept patients in the FIXTURE trial. Continuation of secukinumab was associated with 50.0% and 26.5% of patients regaining response in the CLEAR and FIXTURE trials, respectively.
Lack of data on the reasons for response reduction or loss in both cohorts is a limitation of the study.
“While the mechanisms behind loss of response to biologics are not fully understood,” the researchers added, “a regression analysis revealed that patient factors including baseline body weight, failure to previous biologic treatments and plasma drug levels could influence stability of response.”
Disclosure: This analysis was funded by Novartis Pharma GmbH, Nuremberg, Germany. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Reference
Augustin M, Thaci D, Eyerich K, et al. Continued treatment with secukinumab is associated with high retention or regain of response [published online April 10, 2019]. Br J Dermatol. doi:10.1111/bjd.17991
