Adalimumab Significantly Improves Symptoms of Hidradenitis Suppurativa
A 12-week course of adalimumab, 40 mg weekly, significantly improves symptoms of hidradenitis suppurativa (HS), according to the results of 2 phase 3 trials.
The researchers designed the PIONEER I and II phase 3 trials to examine the safety and efficacy of adalimumab for HS. The trials were conducted in 6 countries; 307 patients were included in the PIONEER I trial, and 326 were included in the PIONEER II trial.
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Both trials were separated into 2 periods. During the first 12 weeks, patients were randomly assigned to either 40 mg of adalimumab weekly or a matching placebo.
Then, for the next 24 weeks, patients in the placebo group in PIONEER I received adalimumab. The patients on adalimumab in the first period in both trials were randomly assigned to 1 of 3 courses: continued adalimumab, adalimumab every other week, or placebo.
The researchers tracked the amount of abscesses and inflammatory nodules from baseline to 12-week follow-up.
After 12 weeks of treatment, patients responded significantly better to the weekly adalimumab than to placebo. No significant differences were seen between the groups beyond 12 weeks.
Those in the PIONEER I trial taking adalimumab had a 41.8% improvement in HS symptoms, whereas those on placebo had a 26.0% improvement. Patients taking adalimumab in the PIONEER II trial had even better response rates than the placebo group (58.9% vs 27.6%, respectively).
Patients in both groups in the PIONEER I trial had similar adverse event rates, but those taking adalimumab in PIONEER II had fewer adverse events than those taking placebo (1.8% vs 3.7%, respectively).
“Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks,” the researchers concluded. “Rates of serious adverse events were similar in the study groups.”
Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa [published online August 4, 2016]. N Engl J Med. doi:10.1056/NEJMoa1504370.