Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series.
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Planella-Fontanillas Nidia, Bosch-Amate Xavier, Jiménez Antón Alicia, Moreno-Vílchez Carlos, Guerrero María Gamo, Blanes Martínez María Del Mar, Ballester Martínez María Asunción, Bassas-Freixas Patricia, Castaño Fernández Juan Luis, Estébanez Corrales Andrea, Suarez Fernández Ricardo, Santos Alarcón Sergio, Alonso Ana Bauzá, Torrent Marina, Ballano Ruiz Adrian, Collantes Rodríguez Cristina, España Agustín, Fonseca Capdevila Eduardo, Faure Inmaculada Gil, Hernández Fernández Carlos Pelayo, Melgosa Ramos Francisco Javier, Spertino Jorge, Zaragoza Ninet Violeta, Armillas Lucia, Bielsa Isabel, Carrera Cristina, Esquius Rafat Mireia, Fulgencio Barbarin Jon, Fernandez Vela Javier, Lova Navarro Miguel, Martín Callizo Clara, Martín-Sala Sara, Ojeda Rosa, Amer Maria Elisabet Parera, Puigdollers Anna Sánchez, Pujol Ramon M, Podlipnik Sebastian, Mascaró José Manuel, Curto-Barredo Laia
Аннотация
OBJECTIVES: Evaluate the effectiveness and safety of dupilumab in the treatment of BP.
METHODS: A multicentre ambispective cohort study was conducted across 34 hospitals. Patients with BP treated with dupilumab were included. Most of the patients (97.1%) received an initial 600-mg dose followed by 300 mg every 2 weeks. The primary outcome was the proportion of patients achieving complete remission (CR) within 4 weeks, defined as an Investigator's Global Assessment score of 0 or 1. CR at weeks 16, 24 and 52, adverse events (AEs), reductions in Peak Pruritus Numerical Rating Scale (PP-NRS) and systemic glucocorticoid use were also assessed.
RESULTS: The study included 103 patients with a median age of 77.3 years; 58.3% were male. CR was achieved by 53.4% within 4 weeks and 95.7% by week 52. The PP-NRS score reduced by 70.0% by week 4 and was completely controlled by week 24. Thirteen patients presented with AEs, most of which were mild. Systemic glucocorticoid use reduced by 82.1% by week 52. Shorter disease duration and exclusive cutaneous involvement predicted better response at 16 weeks. No differences in response rates to dupilumab were observed between drug-associated BP and idiopathic cases. No significant difference in response rates was observed between patients treated with dupilumab in monotherapy and those receiving dupilumab with concomitant treatments.
CONCLUSIONS: Dupilumab is effective, rapid and safe in managing BP, reducing the need for corticosteroids and other treatments. Early initiation and exclusive skin involvement predict better outcomes.