1. In this phase 3 study, 40mg adalimumab weekly resulted in significantly greater improvement in abscess and inflammatory-nodule count with no increase in abscess or draining-fistula at 12 weeks of follow-up.
2. The rates of serious adverse events were similar across groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Hidradenitis suppurativa is a multinodular painful, chronic inflammatory skin disease. As the condition progresses there may also be abscesses and fistulas. Unfortunately, there are not many effective options for treatment. The PIONEER I and II trials looked at the impact of adalimumab, an antibody against tumour necrosis factor α (TNF- α), for hidradenitis suppurativa. This study describes the phase 3 results from this trial to determine if adalimumab shows efficacy against hidradenitis suppurativa.
Clinical response rates at 12 weeks of follow-up were statistically improved in the groups receiving weekly adalimumab as compared to placebo. Those randomized to adalimumab also had greater improvement in secondary outcomes such as lesions, pain, and the modified Sartorius score for disease severity. Serious adverse events were not statistically significant across groups. Limitations of this study include use of a composite outcome (“clinical response”) to determine the primary outcome. Also, the pharmaceutical sponsor was involved in data collection, analysis and interpretation. They also were involved with writing, reviewing and approving this manuscript and thus interpretation of results must be appraised with this in mind.
In-Depth [randomized controlled trial]: PIONEER I and II are multi-centre, randomized, double-blind, placebo-controlled trials. The study population included 633 patients at 101 sites in 14 countries with moderate to severe hidradenitis suppurativa who have not been on a TNF- α blocker. They were randomized to placebo or weekly 40 mg adalimumab. The primary efficacy end point was proportion of patients with clinical response at week 12. Clinical response was defined as Hidradenitis Suppurativa Clinical Response measure of at least 50% reduction from baseline in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count. Outcomes were analyzed in an intention-to-treat fashion, between group differences were analyzed using the Cochran-Mantel-Haenszel test.
At week 12, groups assigned to adalimumab had significantly greater improvement in clinical response than placebo (41.8% vs. 26.0% in PIONEER I, p = 0.003; 58.9% vs. 27.6% in PIONEER II, p < 0.001). There was also improvement in the secondary outcomes of lesions, pain and modified Sartorius score for disease severity. Serious adverse events were 4.6% or less in all groups in both studies with no significant between-group differences.
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