Weekly dosing with adalimumab 40 mg is a safe and effective long-term treatment in patients with moderate to severe hidradenitis suppurativa (HS), according to the results of a pooled analysis of the PIONEER I and II phase 3 clinical trials and an open-label extension (OLE) study (ClinicalTrials.gov identifier: NCT01635764) published in the Journal of the American Academy of Dermatology.
The investigators sought to evaluate the response and tolerability of long-term adalimumab use in patients with HS. All patients who entered the OLE who received adalimumab 40 mg every week continuously (ADAew) and responders plus partial responders (PRR) were assessed. Primary efficacy end points included Hidradenitis Suppurativa Clinical Response (HiSCR), lesion counts, Dermatology Life Quality Index (DLQI), and skin pain.
All patients were followed for ≥96 weeks (36 weeks in PIONEER I or II and ≥60 weeks in the OLE study), with follow-up time varying based on when patients entered the OLE phase. In the ADAew population (n=88), 64% of the patients were women and 92% were white; median patient age was 36 and median duration of HS was 10 years. In the PRR population (n=63), 65% of the patients were women and 91% were white; median patient age was 36 and median duration of HS was 10 years.
At week 12, 52.3% of patients in the ADAew population and 73% of patients in the PRR population attained HiSCR; this was maintained through week 168 by 52.3% of the ADAew group and 57.1% of the PRR group. Patients also reported improvements in lesion count, DLQI, and skin pain, and the safety profile was similar to that noted in the PIONEER studies.
The main limitation of the OLE trial is that the study design was uncontrolled.
The investigators concluded that continuous weekly treatment with adalimumab 40 mg is a reasonable therapeutic option for long-term disease control in patients with moderate to severe HS.
Zouboulis CC, Okun MM, Prens EP, et al. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study [published online May 31, 2018]. J Am Acad Dermatol.