Nomacopan well tolerated in bullous pemphigoid treatment
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Nomacopan was well tolerated and beneficial in patients with bullous pemphigoid, according to phase 2a clinical trial results.
“Pemphigoid diseases constitute a group of autoimmune, blistering skin diseases featuring an autoantibody-directed immune response against proteins of the dermal-epidermal adhesion complex. Bullous pemphigoid is the most common pemphigoid disease,” Christian D. Sadik, MD, of the department of dermatology, allergy and venereology at the University of Lübeck in Germany, and colleagues wrote. “In preclinical studies, investigators have highlighted the nonredundant roles of the anaphylatoxin C5a, an activation product of C5, and the eicosanoid leukotriene B (LTB) in the development of inflammatory skin lesions in pemphigoid diseases.”
This multicenter, single-group, 2a, nonrandomized controlled trial included nine subjects with bullous pemphigoid who were treated with 90 mg of subcutaneous nomacopan, a C5 and leukotriene B inhibitor, on day 1 and then 30 mg subcutaneous nomacopan daily for days 2 to 42.
No patients in the trial experienced severe adverse events related to the treatment
The mean Bullous Pemphigoid Disease Area Index (BPDAI) decreased from 32 on day 1 to 19.6 on day 42. A BPDAI reduction of at least 8 points was recorded in seven of the nine patients, while three patients had a reduction of at least 80%. An additional three patients had a decrease of approximately 40%, and one had a decrease of approximately 30%. Two patients did not have a therapeutic response.
Mean BPDAI pruritus score decreased 6.8 points from day 1 to day 42. Mean DLQI score decreased from 11.3 to 6.2 by day 21 and to 6.4 by day 42.
The trial’s small sample size was one of its limitations, as were its not randomized or placebo-controlled nature. Researchers recommend larger, randomized clinical trials to confirm these results.
“This nonrandomized controlled trial suggested that treatment with nomacopan for 6 weeks can be well tolerated by patients with bullous pemphigoid and that nomacopan might have a pronounced therapeutic benefit for bullous pemphigoid,” the authors wrote.