HealthDay News – Analyses of results from 2 phase 3 clinical trials suggest that adalimumab (ADA) is efficacious at treating moderate to severe hidradenitis suppurativa. These results were recently published in the New England Journal of Medicine. ADA is currently FDA approved for us in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, among other indications. 

Alexa B. Kimball, MD, MPH, from Harvard Medical School and Massachusetts General Hospital in Boston, and colleagues conducted two phase 3 multicenter trials of ADA for hidradenitis suppurativa with two placebo-controlled periods (Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa [PIONEER I, ClinicalTrials.gov Identifier NCT01468207] and Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa [PIONEER II, ClinicalTrials.gov Identifier NCT01468233]). 

Patients were randomized to ADA or placebo for 12 weeks in period one. Patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks in period two. Three hundred seven and 324 patients were enrolled in PIONEER I and PIONEER II.


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The researchers found that the groups receiving ADA weekly had higher clinical response rates at week 12 than those receiving placebo (41.8 versus 26.0 percent in PIONEER I [P = .0003] and 58.9% vs 27.6% in PIONEER II [P < .001]). 

In PIONEER II only, at week 12, patients receiving ADA had significantly greater improvement in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) than those receiving placebo.

Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups,” the authors write.

Summary and Clinical Applicability

Results of these randomized trials suggest that ADA increased likelihood of attaining 50% reduction of abscess and inflammatory nodule count from baseline when compared with placebo.

“The higher disease burden at baseline for patients in PIONEER I (higher mean abscess, inflammatory-nodule, and draining-fistula counts and a higher mean modified Sartorius score) may have led to lower responsiveness to therapy at week 12, thereby contributing to between-study differences in outcomes for the rank-ordered secondary end points,” the authors noted. 

Limitations and Disclosures

  • Studies reviewed were not powered to determine optimal dosing after week 12 of treatment

The NCT01468207 and NCT01468233 clinical trials were sponsored by AbbVie, the manufacturer of Humira® (adalimumab). Several authors disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures adalimumab and funded the study.

Reference

Kimball AB, Okun MM, Williiams DA et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med 2016; 375:422-434