The use of adalimumab in patients with moderate to severe hidradenitis suppurativa (HS) is effective for alleviating the severity of skin pain, with significant changes noted after 2 weeks of treatment, according to the results of the randomized, double-blind, placebo-controlled, parallel-group PIONEER I (ClinicalTrials.gov identifier: NCT01468207) and PIONEER II (ClinicalTrials.gov identifier: NCT01468233) clinical trials, published in the Journal of the American Academy of Dermatology.
The multisite trials included 633 adults with moderate to severe HS who were randomly assigned to receive either 40 mg of adalimumab weekly (n=307) or 0.8 mL placebo (n=326).
Overall, demographic and disease characteristics were similar between the treatment groups, with most participants being female and white (63.8% and 67.8%, respectively; 76.2% and 83.7%, respectively), and with a mean age of 37.0 and 35.5 years, respectively. Average disease duration was 11.5 years.
The Patient’s Global Assessment of Skin Pain (PGA-SP) was administered on a daily basis in both studies, from screening through week 12. Respondents were asked to assess pain “at its worst” in the past 24-hour period, using an 11-point numeric rating scale in which 0 is no skin pain and 10 is pain as bad as you can imagine. At baseline, pain was reported as adalimumab, 6.0, and placebo, 6.0, in PIONEER I, and adalimumab, 5.7, and placebo, 6.2, in PIONEER II.
The proportion of participants who attained a ≥30%, ≥40%, or ≥50% reduction and ≥1 unit reduction from baseline in the PGA-SP with a baseline score ≥3 “was significantly higher for adalimumab vs placebo at each visit in each study except for the 30% and 50% threshold at Week 12 in PIONEER I,” the authors noted. An overall significant treatment effect of adalimumab on pain was demonstrated in both PIONEER I (adalimumab, 40.3% vs placebo, 24.9%; odds ratio, 2.03; P =.004) and PIONEER II (adalimumab, 61.2% vs placebo, 24.8%; odds ratio, 4.78; P <.001).
Moreover, mean change from baseline in PGA-SP scores was significantly lower at all points in the adalimumab group vs the placebo group across both studies. The proportion of time spent at ≥30% pain improvement was significantly higher among adalimumab-treated patients vs placebo-treated patients (41.66% vs 27.11%, respectively [P =.0011], in PIONEER I and 50.62% vs 25.34%, respectively [P <.0001], in PIONEER II).
The investigators concluded that although the longer-term efficacy of adalimumab on HS-associated skin pain and optimal dosing of the agent remain to be determined, the use of adalimumab in adult patients with HS is superior to placebo in the reduction of skin pain associated with the disease.
Kimball AB, Sundaram M, Shields AL, et al. Adalimumab alleviates skin pain in patients with moderate to severe hidradenitis suppurativa: secondary efficacy results from the PIONEER I and PIONEER II randomized controlled trials [published online May 19, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.05.015.