TNFs fail: Etanercept proves ineffective for the treatment of hidradenitis suppurativa

October 1, 2009

A recent trial with etanercept proved largely ineffective in the treatment of hidradenitis suppurativa.

Key Points

Most experts would agree that the current avenues of therapy for HS are only marginally effective and that efforts must be made in order to offer a much-needed relief to patients suffering from this sometimes devastating and debilitating disease.

In a recent 18-week, single-arm, single-dose, non-controlled, open-label, prospective clinical trial, the efficacy and safety of etanercept was evaluated in patients suffering from moderate-to-severe HS.

At week 12, etanercept was tapered to 25 mg per week during a two-week period to minimize the risk of disease flare. Efficacy was measured using Physician Global Assessment (PGA) and several secondary physician- and patient-reported outcome measures, including Dermatology Life Quality Index (DLQI) scores, patient pain scores and number of lesions.

Responders were classified as those achieving at least a 50 percent reduction on the PGA score at week 12 as compared to baseline. Patients were evaluated at baseline and at weeks two, four, eight, 12, 14 and 18.

Study results

Results showed that three out of 15 patients (or 20 percent) who entered the study were classified as responders. Though the DLQI scores showed a minimal improvement from a median of 19 to 15, the PGA scores as well as patient pain scores and lesion counts did not show any statistically significant improvements.

"Tumor necrosis factor-alpha is a pro-inflammatory cytokine that has numerous effects at the cellular level, and these effects may be relevant to the inflammatory aspects of HS. Unfortunately, though, our study with etanercept dosed at 50 mg per week could only show a minimal efficacy in our study population," says Joel M. Gelfand, M.D., M.S.C.E., medical director, Clinical Studies Unit, assistant professor of dermatology and associate scholar, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Health System, Philadelphia.

The other 12 patients evaluated in the study either fared the same or experienced a worsening of their condition, and of the three patients who slightly benefited from the treatment, Dr. Gelfand says it remains unclear whether they responded because of the drug, because of the placebo effect or because of a natural remission of their disease.