Clinical trial data published in the Journal of the European Academy of Dermatology & Venereology indicate that weekly adalimumab treatment reduces flare incidence, duration, and severity in patients with hidradenitis suppurativa (HS). In addition, patients with fewer flares reported significantly improved health-related quality of life HRoL).
Investigators integrated data from two phase 3 studies (PIONEER I and II) and the initial portion of an open-label extension study. PIONEER I and II both had 2 double-blind periods: a 12-week period (period A) and a subsequent 24-week period (period B). During period A, patients in both trials were randomly assigned 1:1 to receive either weekly adalimumab or placebo. In period B, patients taking adalimumab were again randomly assigned to receive weekly adalimumab, adalimumab every other week, or placebo; patients initially assigned to placebo were switched to weekly adalimumab (PIONEER I) or continued with placebo (PIONEER II) from weeks 12 to 36. Patients in the period B placebo group were rescued into the open-label extension study if they experienced worsening symptoms. The primary end point at week 12 was HS clinical response, defined as a ≥50% improvement in total abscess and inflammatory nodule count. HS disease flare, defined as a ≥25% increase in total abscess and inflammatory nodule count, was assessed through 36 weeks. Change from baseline in health-related quality of life was captured using the Dermatology Life Quality Index. Flare characteristics and HRQoL were compared in treatment groups.
A total of 633 patients were included in period A, of whom 316 received weekly adalimumab and 317 received placebo. Demographic characteristics were similar between study groups, although the majority of patients were women (>60.0%). During period A, the percentage of patients experiencing at least 1 flare was significantly lower in the weekly adalimumab group compared with the placebo group (12.3% vs 35.3%; P <.001). Mean time to flare was significantly higher in patients taking weekly adalimumab vs placebo (101 vs 57 days; P <.001). In addition, mean flare duration was significantly shorter in the weekly adalimumab group compared with the placebo group (18.9 vs 32.0 days; P =.001). The percentage of patients experiencing multiple flares was also significantly lower in the weekly adalimumab group vs the placebo group (5.4% vs 17.7%; P <.001). Through period B, 20.2% of patients receiving weekly adalimumab experienced flares. However, in patients who had at least a partial initial response to weekly adalimumab at week 12, only 5.7% experienced a flare during period B. Quality of life at week 12 was significantly improved from baseline in patients who did not experience flares compared with patients who did (least-squares mean difference, 3.9; 95% CI, -4.8 vs -0.9; P <.001).
As study limitations, investigators cited the lack of a “reliable control group” past week 12; the majority of patients receiving placebo in period B were rescued to the open-label extension study. In addition, results may not be generalizable to patients with milder forms of HS.
Flare reduction was significantly correlated with HRQoL in patients with HS. Weekly adalimumab was found to reduce HS flare through 12 and 36 weeks of treatment. Overall, “These data demonstrate the positive effect of weekly adalimumab treatment on incidence of HS disease flare, time to flare, and duration of flare,” investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures
van der Zee HH, Longcore M, Geng Z, Garg A. Weekly adalimumab treatment decreased disease flare in hidradenitis suppurativa over 36 weeks: integrated results from the phase 3 PIONEER trials [published online October 20, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.16023