SAN FRANCISCO – Weekly treatment with 40 mg of adalimumab yielded the strongest clinical responses in adults with moderate to severe hidradenitis suppurativa with a safety profile similar to less intensive doses, according to data from two phase III trials.
Overall, 43% of adalimumab-treated patients achieved the predefined clinical response at 36 weeks, compared with 28% of patients who first received adalimumab and switched to placebo, Dr. Alexa Kimball said at the annual meeting of the American Academy of Dermatology. The 40-mg weekly dose also beat placebo in demographic subgroup analyses, said Dr. Kimball, professor of dermatology at Harvard Medical School in Boston. “Greater responses rates with this dose, combined with no difference in safety across the three treatment arms, suggests that weekly dosing was the optimal medium-term dosing strategy in hidradenitis suppurativa,” she added.
Hidradenitis suppurativa (also called acne inversa) is a chronic follicular occlusive skin disease that affects about 1%-4% of adults, particularly women, smokers, and obese or overweight patients. The disease has very few treatment options. Patients can develop recurrent abscesses, draining sinuses, and scarring, all of which negatively affect quality of life.
Adalimumab is an anti–tumor necrosis factor–alpha agent that previously bested placebo for hidradenitis suppurativa in phase II trials. Dr. Kimball and associates analyzed data on 633 patients with moderate to severe disease from two phase III, placebo-controlled trials (PIONEER I and II). For the first 12 weeks, patients were randomized to placebo or to 40 mg of adalimumab weekly. At week 12, patients were rerandomized to 40 mg adalimumab weekly, 40 mg of adalimumab every other week, or to placebo. The researchers defined treatment response as at least a 50% drop in abscesses and inflammatory nodules, with no numerical increase in individual numbers of abscesses or draining fistulas.
At week 12, 50.6% of patients who had received 40 mg of adalimumab weekly had achieved treatment response, compared with 26.8% of the placebo group (P < .001), with no new or unexpected adverse events, said Dr. Kimball. The weekly 40-mg dose also beat placebo in subgroups stratified by smoking status, sex, disease duration, disease severity, and age, she said. Adalimumab outperformed placebo for patients of black race or who had a body mass index (BMI) of at least 40 kg/m2, although the differences did not reach statistical significance. Treated patients also had 23% fewer flares (defined as a 25% increase in lesion count; P = .001), and 18.9 average days of flare, compared with 32 days for the placebo group (P = .001), Dr. Kimball reported.
Past studies have linked adalimumab to serious systemic infections, demyelinating disorders, and lymphoma and other malignancies. No patients in the PIONEER trials developed these adverse events except for nonmelanoma skin cancer, said Dr. Kimball. In all, 2% of patients in each arm developed adverse events that led them to stop treatment, she added. Rates of infection were similar among the treatment groups. Although one patient (1%) on 40 mg weekly for 36 weeks developed pneumonia, none of the patients in the other arms developed serious infections.
Abbvie is the manufacturer of adalimumab and sponsored the trials. Dr. Kimball reported receiving consulting honoraria and research grants from Abbvie and several other pharmaceutical companies.