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This new data indicates that dupilumab in this patient population had favorable efficacy and safety, though some unique concerns were risk of infection and eosinophilia.
Dupilumab treatment improves clinical symptoms in patients with bullous pemphigoid (BP), according to recent findings, though concurrent infection and eosinophilia should also be considered.1
These findings were the result of a study conducted to assess the efficacy as well as the safety of the atopic dermatitis treatment regimen of dupilumab for individuals with bullous pemphigoid. The study was also designed to examine factors that could affect both short-term as well as long-term outcomes in these patients.
Bullous pemphigoid is known to be quite a prevalent autoimmune bullous disease, and it is known for its distinctive features, including erythema, tense blisters, and intense itching. Therefore, this study was conducted to address patient concerns and the research was authored by Meng Pan, MD, PhD, from the Department of Dermatology at Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine in China.
“Recent case reports and small-scale control studies regarding the use of dupilumab, blocking IL-4 receptor alpha (IL-4Rα), on BP have confirmed its possible efficacy and preferable safety profiles compared with conventional treatment,” Pan and colleagues wrote. “Based on this, a clinical study was designed and conducted to determine the efficacy, safety, and prognostic risk factors of dupilumab in BP treatment.”2
The investigators conducted their research between January of 2021, and July of 2022, using a retrospective cohort design and a median follow-up period of 24.6 weeks. The team’s multicenter study was performed in 6 dermatology departments included in the National Autoimmune Bullous Diseases Cooperative Group of China.
Adult patients with bullous pemphigoid who were given 300 mg of dupilumab every 2 weeks following a first dose of 600 mg were included in the study, provided they had a clinical presentation of the disease and immunological or pathological evidence. Those with less than 4 weeks of follow-up, drug-induced bullous pemphigoid, or those who were given dupilumab or any other biologics within 6 months were excluded from the study by the investigators.
The investigators’ primary outcome of interest was the proportion of patients who achieved disease control within 4 weeks, defined as the absence of new lesions and pruritus, combined with the healing of existing lesions. Additionally, the research team examined complete relapse rates, remission rates, Bullous Pemphigoid Disease Area Index (BPDAI) score shifts, laboratory results within 64 weeks, scores on the itching numerical rating scale (NRS), and adverse events.
The team ended up including 146 total participants, all of which had a median age of 73 years and 58.9% of which were male. Within 4 weeks, the investigators reported that 87.0% of the participants were able to achieve disease control, with the median time being 14 days.
Additionally, the research team found that 35.6% of participants achieved complete remission, and 8.9% were found to have experienced relapse during the period of observation. At 64 weeks, the team reported that the complete remission rate was found to be 62.5% and the cumulative relapse rate was shown to be 30.9%.
Following treatment with the drug, the investigators noted significant and sustained improvement in participants’ clinical indicators as well as their laboratory examination results, including itching NRS scores, total IgE levels, BPDAI scores, serum anti-BP180 and anti-BP230 antibodies, and eosinophil count. Out of the 146 patients, they found that 73.3% did not report any adverse events, and the most common ones were infections and eosinophilia.
The research team also reported that serum anti-BP180 antibody levels over 50 relative units (RU)/mL were found to have been linked with 4-week disease control, and male participants were also more likely to report relapses.
“Considering that patients with BP are mostly older adults with multiple comorbidities, physicians should carefully monitor the clinical changes of patients after the application of dupilumab,” they wrote. “We additionally found that there was an emergence or recurrence of psoriasis during treatment with dupilumab. Therefore, the use of dupilumab in patients with BP combined with psoriasis should be carefully considered.”