Clinical Trial: Anakinra in Hidradenitis Suppurativa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo-controlled Clinical Trial of the Safety and Efficacy of Anakinra in Patients With Hidradenitis Suppurativa

Brief Summary: Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and the efficacy of anakinra over placebo for the management of patients with hidradenitis suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the comparisons of visual analogue scores, of disease activity, of Sartorius score and of dermatology life quality index between the two groups of treatment over follow-up.

Detailed Summary:

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas; they progressively become swollen and rupture with the release of pus. This process occurs repeatedly leading to sinus tract formation and scars. This disease course creates a frustrating situation for the patients but also for physicians. Traditional treatments comprise short-courses of antibiotics and surgical excision. However, relapse is the rule so that HS leads to severe impairment of the quality of life. The Dermatology Quality Life Index (DQLI) for HS is 8.9 being higher than any other skin disorder.

This devastating disorder has often been neglected and considered a rare situation. However, HS seems to indiscriminately affect the global population. Although the exact epidemiology is largely unknown, the point-prevalence is reported to range between 1% and 4%. A recent large epidemiological survey in France reports 0.97% disease prevalence.

The exact pathophysiology of HS is unknown. Smoking, dietary habits and genetic predisposition have all been linked with HS. However, a recent survey by our group in 56 patients, disclosed a severe derangement of the monocyte function and of subsequent antigen processing in these patients. The percentage of natural killer (NK) cells was increased and that of CD4-lymphocytes decreased compared to healthy controls probably implying the existence of an autoimmune predilection for the disorder. We have previously demonstrated defective lipopolysaccharide (LPS)-induced production of the pro-inflammatory cytokines, tumour necrosis factor(TNF) and interleukin (IL)-6 by blood monocytes of patients with HS.

As a consequence, a hypothesis for the implication of some autoimmune of autoinflammato
Sponsor: University of Athens

Current Primary Outcome: The efficacy of anakinra in patients with HS of Hurley II and III stage disease. [ Time Frame: 24 weeks ]

This will be defined by the changes of scoring parameters between the two study groups over visits.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The effect of anakinra in the ex vivo function of monocytes of patients with HS. [ Time Frame: 24 weeks ]
    This will be defined by the differences of cytokines produced by PBMCs between the two study groups over visits.
  • The effect of anakinra on the time to new exacerbation [ Time Frame: 24 weeks ]
    This will be defined by the differences between the two study groups over visits.
  • The safety of anakinra in patients with hidradenitis suppurativa [ Time Frame: 24 weeks ]
    This will be assessed by the development of serious and non-serious drug-related adverse events


Original Secondary Outcome: Same as current

Information By: University of Athens

Dates:
Date Received: March 15, 2012
Date Started: March 2012
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015