Adalimumab for Hidradenitis Suppurativa

I wrote about Hidradenitis Suppurativa in an earlier post. Of interest is a recent NEJM article on the use of Adalimumab for the treatment of this horrible disease.

 

In the phase three trial:

 

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. We enrolled 307 patients in PIONEER I and 326 in PIONEER II. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I (P=0.003) and 58.9% versus 27.6% in PIONEER II (P<0.001). 

 

Their protocol:

In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12.

 

The use of this TNF-alpha inhibitor demonstrated efficacy, but not a cure for this scarring and painful disease. Significant improvement was noted in the rank ordered secondary outcomes of lesion count, pain score, and disease severity.

 

The wording goes:

In conclusion, these two randomized trials involving patients with moderate-to-severe hidradenitis suppurativa showed that adalimumab substantially increased the likelihood of a clinically significant response at week 12, as defined by at least a 50% reduction from baseline in the total abscess and inflammatory-nodule count and no increase in abscess or draining-fistula counts, with or without continued antibiotic treatment.

Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa

 

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