Clinical Trial: Anti-IL-5 Therapy in Bullous Pemphigoid (BP)

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

Official Title: Anti-IL-5 Therapy in Bullous Pemphigoid. Randomized, Placebo-controlled, Double-blind Study Evaluating the Effect of Anti-IL-5 Therapy in Patients With Bullous

Brief Summary: Randomized, placebo-controlled, double-blind study evaluating the effect of anti-IL-5-therapy in patients with bullous pemphigoid. The primary study objective is to determine the efficacy of an anti-IL-5 monoclonal antibody therapy, administered as 750mg mepolizumab, in patients with bullous pemphigoid.

Detailed Summary:

Background

Bullous pemphigoid (BP) is the most common autoimmune blistering skin disease. It characteristically affects the elderly (>70 years) with an annual incidence of 5 to 35 per million. This is comparable with the incidence of eosinophilic esophagitis that we determined with approximately 14 per million. Eosinophilic esophagitis has been recognized as an emerging medical problem and, consequently, several studies with anti-IL-5-antibodies have been performed and are still ongoing. It should be noted, however, that, in contrast to eosinophilic esophagitis, the incidence of BP is dramatically increasing with an average of 17% per year. Moreover, with the increase of the proportion of the elderly in the industrialized world, the medical problems associated with BP will even be more visible in the near future. For instance, patients with BP have an increased mortality risk of 2.3. In the US, an increase in mortality of BP patients has been noticed from 1979 to 2002. Taken together, BP is a frequent disease that affects mostly the elderly.

BP often starts with extremely pruritic skin lesions resembling eczema or urticaria before vesicles and blisters arise. In 10-30% of patients, BP also involves the oral mucosa. Disease severity can be determined by means of the autoimmune bullous skin disorder intensity score (ABSIS) that evaluates the involved area as well as the disease activity. The disease is due to an autoimmune response to structural components of junctional adhesion complexes leading to the damage of the dermal-epidermal junction with subepidermal blister formation. Specifically, autoreactive B and T cell responses against the hemidesmosomal antigens BP180 and BP230 have been identified. Serum levels of autoantibodies to BP180 reflect the disease severity and activity. The T cells are memory CD4+ cells produc
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Time period (in days) from start of therapy until relapse, mepolizumab vs placebo [ Time Frame: Before, at 3-9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes of BP severity score over time (ABSIS) [ Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) ]
  • Changes of pruritus score (visual analog scale) [ Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) ]
  • Changes of BP-antibody titers over time [ Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) ]
  • Number of patients with AE, severity of AE [ Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) ]


Original Secondary Outcome:

  • Changes of BP severity score over time (ABSIS) [ Time Frame: At baseline, during therapy, follow up ]
  • Changes of pruritus score (visual analog scale) [ Time Frame: At baseline, during therapy, follow up ]
  • Changes of BP-antibody titers over time [ Time Frame: At baseline, during therapy, follow up ]
  • Number of patients with AE, severity of AE [ Time Frame: At baseline, during therapy, follow up ]


Information By: University Hospital Inselspital, Berne

Dates:
Date Received: October 5, 2012
Date Started: February 13, 2013
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017