Abstract
The authors recently published a systematic review showing a robust placebo response in randomized clinical trials (RCTs) for hidradenitis suppurativa (HS), especially for physical signs. Three additional international/US-based RCTs for moderate-severe HS patients have been reported that did not meet the primary end point and demonstrated high placebo responses (n = 66-179). Four active doses of IFX-1 (IV anti–human complement factor C5a monoclonal antibody; InflaRx) were compared with placebo. IFX-1 treatment achieved a maximum HS Clinical Response (HiSCR) rate of 51.5% while placebo resulted in HiSCR of 47.1%. An RCT investigated MEDI8968 (subcutaneous interleukin-1 receptor 1 inhibitor, AstraZeneca). 23.6% of participants were responders in the active arm (PGA score of 0, 1 or 2 at week 12) compared with 18.5% of those receiving placebo. The study was terminated early. The third RCT compared CJM112 (subcutaneous anti–IL-17A monoclonal antibody; Novartis) versus placebo. Of those receiving active treatment, 32% were responders (decrease in HS-PGA of at least 2 points), while 12.5% of those receiving placebo met this definition. In order to accommodate the large and variable placebo response in HS, the following should be considered: recruit HS patients from well established HS practices, stratify recruitment and randomization across all spectrums of disease activity, employ a trial duration which will account for the natural history of the disease, agree upon a verified set of primary and secondary outcomes; and employ diagnostic imaging techniques to mitigate subjectivity in assessing outcomes. Furthermore, publishing negative outcomes should be encouraged in order to learn from all HS RCTs.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.