Infliximab therapy for patients with moderate to severe hidradenitis suppurativa:
a randomized, double-blind, placebo-controlled crossover trial.
Author(s): Grant A, Gonzalez T, Montgomery MO, Cardenas V, Kerdel FA.
Affiliation(s): Florida Academic Dermatology Centers, Miami, Florida 33136, USA.
Publication date & source: 2010, J Am Acad Dermatol. , 62(2):205-17
BACKGROUND: Biologic therapies with anti-tumor necrosis factor agents are
promising treatments for hidradenitis suppurativa (HS).
OBJECTIVE: We assessed the efficacy and safety of infliximab (IFX) for the
treatment of moderate to severe HS.
METHODS: A prospective double-blind treatment phase of 8 weeks where patients
received IFX or placebo was followed by an open-label phase where patients taking
placebo were given the opportunity to cross over to IFX, and an observational
phase. Primary treatment efficacy was based on HS Severity Index. Secondary end
points included Dermatology Life Quality Index, visual analog scale, and
Physician Global Assessment scores. Inflammatory markers erythrocyte
sedimentation rate and C-reactive protein were also assessed.
RESULTS: More patients in the IFX than in the placebo group showed a 50% or
greater decrease from baseline HS Severity Index score. In addition,
statistically and clinically significant improvement from baseline was observed
at week 8 in Dermatology Life Quality Index score, visual analog scale score,
erythrocyte sedimentation rate, and C-reactive protein compared with placebo.
Patients in the placebo group treated with IFX after week 8 (crossover) responded
similarly to the original IFX group. Many patients withdrew during the
observational phase to continue anti-tumor necrosis factor-alfa therapy. No
unexpected serious adverse events were observed.
LIMITATIONS: Results are representative of a single center, patients were treated
by a single physician, some patients did not return after their last infusion,
and the HS Severity Index requires validation.
CONCLUSIONS: This clinical study represents the first formal assessment of IFX
for treatment of moderate to severe HS. IFX was well tolerated, no unexpected
safety issues were identified, and improvements in pain intensity, disease
severity, and quality of life were demonstrated with concomitant reduction in
clinical markers of inflammation.
|