Achievement and maintenance of therapeutic response to brodalumab in patients with moderate‐to‐severe plaque psoriasis: An Italian, observational, retrospective and prospective study (BRIGHT study)

Author:

Dapavo Paolo1,Fabbrocini Gabriella2,Campione Elena3,Giofrè Claudia4,Balato Anna5ORCID,Potenza Concetta6,Dastoli Stefano7,Malagoli Piergiorgio8,Offidani Annamaria9,Bardazzi Federico10,Peris Ketty11ORCID,Pella Paolo12,De Pasquale Rocco13,Bonifati Claudio14,Giacchetti Alfredo15,Pallotta Sabatino16,Congedo Maurizio17,Amerio Paolo18ORCID,Fargnoli Maria Concetta1920ORCID,Calzavara Pinton Piergiacomo21ORCID,Venturini Marina21ORCID,

Affiliation:

1. SC Dermatologia A.O.U. Citta della Salute e della Scienza P.O.Molinette Torino Italy

2. UOC Clinica Dermatologica A.O.U. Federico II Napoli

3. UOSD Dermatologia Policlinico Tor Vergata Roma Italy

4. U. O. C. Dermatologia Azienda Ospedaliera Papardo Messina Italy

5. Clinica Dermatologica Policlinico Luigi Vanvitelli Napoli Italy

6. UOC Dermatologia Universitaria Ospedale A. Fiorini Terracina Italy

7. UO Dermatologia A.O.U. Mater Domini Catanzaro Italy

8. Dermatologia Policlinico San Donato San Donato Milanese Italy

9. SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi Ancona Italy

10. UO Dermatologia A.O.U. Policlinico S. Orsola‐Malpighi Bologna Italy

11. UOC Dermatologia Fondazione Policlinico Universitario A. Gemelli Roma Italy

12. SSD Dermatologia Ospedale degli Infermi Ponderano Italy

13. Dermatologia A.O.U. Policlinico‐Vittorio Emanuele PO S.Marco Catania Italy

14. Dermatologia Istituto Dermatologico San Gallicano Roma Italy

15. UOC Dermatologia I.N.R.C.A Ancona Italy

16. V Divisione Dermatologica I.D.I. Roma Italy

17. UO Dermatologia Ospedale Vito Fazzi Lecce Italy

18. Centro di Ricerca Clinica CAST Università dell'Adriatico ‘G. D'Annunzio' di Chieti e Pescara Chieti Italy

19. Dipartimento di Scienze Cliniche Applicate e Biotecnologiche Università degli studi dell'Aquila L'Aquila Italy

20. Unità di Dermatologia Ospedale San Salvatore L'Aquila Italy

21. UOC Dermatologia ASST Spedali Civili Brescia Italy

Abstract

AbstractBackgroundBrodalumab, a fully human anti‐interleukin (IL)‐17 monoclonal antibody that blocks IL‐17RA, is approved in Europe for the treatment of adult patients with moderate‐to‐severe plaque psoriasis who are candidates for systemic treatment.ObjectivesThis study evaluated the achievement and maintenance of therapeutic response for 1 year in psoriasis patients treated with brodalumab in the Italian clinical practice.MethodsReal‐world, multicenter, observational, retrospective and prospective study. The retrospective phase ranged from enrolment visit to initiation of brodalumab (12 ± 4 weeks before). The prospective phase ranged from enrolment to a routine follow‐up visit set after 52 ± 4 weeks.ResultsOne hundred eighty‐four patients were eligible and 164 completed the observation period (median 11.9 months; Q1–Q3: 11.4–12.3). At enrolment, the mean duration of disease was 13.9 years (standard deviation; 13.3), 94% of patients (N = 172) had ≥1 clinical manifestation of psoriasis, mainly erythema and itching, and 95.6% had received ≥1 antipsoriatic treatment before brodalumab. Patients who reached an absolute Psoriasis Area and Severity Index (PASI) score ≤3 at week 12 and maintained it ≤3 through week 52 were 97 (64.7%). At week 12, 72.7% of patients achieved PASI 75, 54.5% PASI 90 and 42.0% PASI 100. At Week 52, 92.9% of patients achieved PASI 75, 84.4% PASI 90 and 61.7% PASI 100. A static Physician's Global Assessment (sPGA) score = 0 was obtained by 55.0% of patients after 12 weeks of brodalumab and by 77.0% after 52 weeks. A Dermatology Life Quality Index ≤1 was reported by 71.9% of patients after 12 weeks and by 89.9% after 52 weeks of treatment. No significant outcome differences were shown among patient subgroups defined by previous antipsoriatic treatments (none, systemic other than biologics or biologic) at either brodalumab initiation or any of the subsequent study visits.ConclusionsIn this real‐world setting, brodalumab was rapidly effective on skin lesions and quality of life both in biologic‐naïve and biologic‐experienced moderate‐to‐severe psoriasis patients, with a favourable safety profile.

Publisher

Wiley

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