Nomacopan shows therapeutic potential in older patients with bullous pemphigoid
The C5 and leukotriene B4 inhibitor nomacopan helps suppress acute flares in older patients with bullous pemphigoid, according to the results of a phase IIa study.
The study involved nine patients (median age 75 years, 55.6 percent women) with mild-to-moderate, new-onset, or relapsing bullous pemphigoid. All of them received nomacopan 90 mg on day 1, then 30 mg daily until day 42. Treatment was administered subcutaneously.
Of the patients, five (55.6 percent) presented with a first episode of bullous pemphigoid and four (44.4 percent) with relapsing disease. Two patients (22.2 percent) had mild disease, while seven (77.8 percent) had moderate bullous pemphigoid. Four patients had been on topical corticosteroids prior to entering the trial.
Treatment was well tolerated, and none of the patients developed grade 3 to 5 (severe) adverse events associated or possibly associated with the investigational drug.
In terms of efficacy, the mean Bullous Pemphigoid Disease Area Index (BPDAI) activity score dropped from 32.0 points on day 1 to 19.6 points on day 42. Seven patients (77.8 percent) responded to treatment, with a decrease in the BPDAI activity score of at least 8 points between during follow-up.
Of note, three responders showed a reduction in disease activity of ≥80 percent. On day 42, the mean BPDAI pruritus score declined by 6.8 points from 17.6 points on day 1.
The mean Dermatology Life Quality Index (DLQI) score fell from 11.3 points at baseline to 6.4 points by day 42. Meanwhile, the corresponding changes in Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) decreased from 14.6 points at baseline to 10.3 points on day 42.
The findings warrant larger placebo-controlled, randomized clinical trials to confirm nomacopan and to establish the drug as a new therapeutic option for bullous pemphigoid.