Preferences and satisfaction of IBD patients after switching from adalimumab 40 mg weekly to 80 mg every other week given as a single injection: the ADASCAL study

Carlos Taxonera; María Pilar Martínez-Montiel; Manuel Barreiro-de-Acosta; Isabel Vera; Rufo Lorente; Pablo Vega; María Teresa Diz-Lois; Ana María Fuentes Coronel; José Lázaro Pérez Calle; Begoña Casis; Rocío Ferreiro-Iglesias; Marta Calvo; David Olivares; Cristina Alba

doi:10.1177/17562848211056157

Preferences and satisfaction of IBD patients after switching from adalimumab 40 mg weekly to 80 mg every other week given as a single injection: the ADASCAL study

Therap Adv Gastroenterol. 2021 Nov 24:14:17562848211056157. doi: 10.1177/17562848211056157. eCollection 2021.

Authors

Affiliations

¹ Inflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico Universitario San Carlos, c/Profesor Martín Lagos s/n, 28040 Madrid, SpainInstituto de Investigación del Hospital Clínico San Carlos [IdISSC], Madrid, Spain.
² Gastroenterology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
³ Gastroenterology Department, Hospital Clínico Universitario de Santiago, Santiago, Spain.
⁴ Gastroenterology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
⁵ Gastroenterology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
⁶ Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.
⁷ Gastroenterology Department, Hospital Universitario de A Coruña, A Coruña, Spain.
⁸ Gastroenterology Department, Hospital Virgen de la Concha, Zamora, Spain.
⁹ Gastroenterology Department, Hospital Universitario Fundación Alcorcon, Madrid, Spain.
¹⁰ Gastroenterology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain.

Abstract

Background: A recently registered device containing 80 mg of adalimumab (ADA) allows an alternative dose escalation regimen with ADA 80 mg every other week (EOW) given as a single subcutaneous injection instead of 40 mg every week. The ADASCAL study evaluated the preferences and satisfaction of inflammatory bowel disease (IBD) patients after switching their ADA regimen from 40 mg weekly to 80 mg EOW given with a single-dose pen.

Methods: In this multicentre cross-sectional study, patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW completed the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), a four-item questionnaire [a Likert-type 5-point scale for preferences, two closed questions for convenience and a 100-point visual analogue scale (VAS) to assess which escalated ADA regimen patients would prefer to continue] and two Health-Related Quality of Life (HRQoL) questionnaires: the generic European Quality of Life-5 Dimensions (EQ-5D) and disease-specific Spanish version of the Inflammatory Bowel Disease Questionnaire (SIBDQ-9).

Results: In total, 77 patients (64 Crohn's disease and 13 ulcerative colitis) were included. The TSQM score showed a notably high global satisfaction [83.4, standard deviation (SD) = 14.1] of patients with ADA 80 mg EOW given with a single-dose pen, with high TSQM scores for individual components: effectiveness (77.6, SD = 16.9), convenience (83.7, SD = 14.5) and side effects (86.1, SD = 23.4). Most of the patients (74%) preferred the ADA EOW regimen (59.7% had strong preference, 14.3% slight preference). ADA EOW interferes less with daily activity (59.7%) and with travel plans (81.8%). Most patients (77%) would prefer to continue with ADA EOW (mean VAS score of 84.7, SD = 24.1, where 100 indicates a preference for ADA EOW). Patients reported high HRQoL scores on both the EQ-5D (72.3, SD = 20.1) and SIBDQ-9 (75.1, SD = 14.7).

Conclusion: IBD patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW reported a higher preference for the EOW regimen and therefore most decided to continue with a single self-injection EOW.

Keywords: adalimumab; dose escalation; inflammatory bowel disease; patient-reported experience measures; single-dose pen.