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Multicenter Study
. 2025 Feb 18;192(3):501-509.
doi: 10.1093/bjd/ljae403.

Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series

Nidia Planella-Fontanillas  1 , Xavier Bosch-Amate  2 , Alicia Jiménez Antón, Carlos Moreno-Vílchez, María Gamo Guerrero, María Del Mar Blanes Martínez, María Asunción Ballester Martínez, Patricia Bassas-Freixas, Juan Luis Castaño Fernández, Andrea Estébanez Corrales, Ricardo Suarez Fernández, Sergio Santos Alarcón, Ana Bauzá Alonso, Marina Torrent, Adrian Ballano Ruiz, Cristina Collantes Rodríguez, Agustín España, Eduardo Fonseca Capdevila, Inmaculada Gil Faure, Carlos Pelayo Hernández Fernández, Francisco Javier Melgosa Ramos, Jorge Spertino, Violeta Zaragoza Ninet, Lucia Armillas, Isabel Bielsa, Cristina Carrera  2 , Mireia Esquius Rafat, Jon Fulgencio Barbarin, Javier Fernandez Vela, Miguel Lova Navarro, Clara Martín Callizo, Sara Martín-Sala, Rosa Ojeda, Maria Elisabet Parera Amer, Anna Sánchez Puigdollers, Ramon M Pujol  1 , Sebastian Podlipnik  2 , José Manuel Mascaró Jr  2 , Laia Curto-Barredo  1
Affiliations
Multicenter Study

Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series

Nidia Planella-Fontanillas et al. Br J Dermatol. .

Abstract

Background: Bullous pemphigoid (BP) affects elderly individuals with multiple comorbidities, making conventional treatments unsuitable.

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.

Plain language summary

Bullous pemphigoid (BP) is an autoimmune skin disease that affects elderly people. BP causes large, fluid-filled blisters on the skin and can be very itchy and uncomfortable. Traditional treatments often use corticosteroids, but these can have serious side-effects, especially for older adults who might have other health conditions. In this study, we wanted to see if dupilumab (a newer drug) is effective and safe for treating BP. Dupilumab has already been approved for other skin conditions and works by blocking certain proteins that cause inflammation. This study was carried out in Spain and involved 34 hospitals. We studied 103 patients treated with dupilumab from August 2020 to February 2024. We tracked their progress for at least 4 weeks, looking at how well the drug worked and any side-effects. We found that more than half of the patients (53.4%) saw their symptoms completely clear up within 4 weeks, and nearly all (95.7%) had clear skin by 52 weeks. Itchiness decreased by 70.0% in the first 4 weeks and was completely gone by week 24 for many patients. The use of corticosteroids dropped significantly, by over 80% within 52 weeks. Finally, we found that only 12.6% of patients had side-effects, mostly mild. Overall, our findings suggest that dupilumab is an effective and safe treatment for BP by reducing symptoms and use of corticosteroids. Patients with a shorter duration of BP and those with only skin symptoms responded the best. This drug offers a promising new option for managing BP.

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Conflict of interest statement

Conflicts of interest: C.M.-V. has served as a speaker for Leo Pharma and Sanofi. M.A.B.M. has participated as a principal investigator or sub-investigator in clinical trials for bullous pemphigoid funded by Argnx, AstraZeneca and Regeneron. J.S. has served as a medical advisor, speaker and/or has received research funding from Abbvie, Leo Pharma, Lilly, Noucor, Novartis and Sanofi Genzyme. C.M.C. has received funding from Sanofi for activities related to her work. S.M.-S. has received funding from Sanofi for attending congresses. J.M.M.Jr has served as a speaker or consultant for ADIMYF, Astra Zeneca, Bocentium Consulting, Fundacio Clinic Per La Recerca, Fundació Institut de Recerca Hospital de la Santa Creu i Sant Pau, Fundacion Piel Sana de la AEDV, Grupo Español de Trasplantes Hematopoyéticos y Terapia Celular, Janssen, Laboratorios Viñas, MFAR, Organon Salud, Sanofi-Aventis and Viatris Pharmaceuticals, all outside the submitted work. He has participated as principal investigator in clinical trials for bullous pemphigoid funded by AstraZeneca. L.C.-B. has served as a speaker, medical advisor and/or consultant for Abbvie, Leo Pharma, Lilly, Novartis and Sanofi.

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