Adalimumab es efectivo para hidradenitis supurativa.

Adalimumab Effective for Hidradenitis Suppurativa

The New England Journal of Medicine

BACKGROUND

Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa.

METHODS

PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. 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.

RESULTS

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). Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only. Serious adverse events in period 1 (excluding worsening of underlying disease) occurred in 1.3% of patients receiving adalimumab and 1.3% of those receiving placebo in PIONEER I and in 1.8% and 3.7% of patients, respectively, in PIONEER II. In period 2, the rates of serious adverse events were 4.6% or less in all the groups in both studies, with no significant between-group differences.

CONCLUSIONS

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.

• Article Citation

The New England Journal of Medicine

Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa

N. Engl. J. Med 2016 Aug 04;375(5)422-434, AB Kimball, MM Okun, DA Williams, AB Gottlieb, KA Papp, CC Zouboulis, AW Armstrong, F Kerdel, MH Gold, SB Forman, NJ Korman, EJ Giamarellos-Bourboulis, JJ Crowley, C Lynde, Z Reguiai, EP Prens, E Alwawi, NM Mostafa, B Pinsky, M Sundaram, Y Gu, DM Carlson, GB Jemec 

TAKE-HOME MESSAGE

• Hidradenitis suppurativa is an inflammatory skin disease with common manifestations including recurrent abscesses and inflammatory nodules necessitating surgical management. The authors of these two randomized trials evaluated adalimumab in individuals with hidradenitis suppurativa, with the primary outcome being at least 50% reduction in abscess or inflammatory nodule count at 12 weeks. Treatment with adalimumab was associated with significant improvement in objective measures of disease burden 12 weeks after randomization. Additionally, adalimumab was associated with improvements in skin-related pain and Sartorius score, a measure of disease severity, in the second trial but not the first.

• Adalimumab appears to be an effective treatment option for individuals with moderate to severe hidradenitis suppurativa.

  – Matthew Resnick, MD