Rapidity of clinical response to adalimumab and improvement of quality of life in luminal Crohn's disease: RAPIDA study

• Published in: Gastroenterología y Hepatología (English Edition) 2022-03, Vol.45 (3), p.165-176
• Main Authors: Marín-Jiménez, Ignacio, Acosta, Manuel Barreiro-de, Esteve, María, Castro-Laria, Luisa, García-López, Santiago, Ceballos, Daniel, Echarri, Ana, Martín-Arranz, María Dolores, Busquets, David, Llaó, Jordina, Navarro-Llavat, Mercè, Huguet, José María, Argüelles-Arias, Federico, Vicente, Raquel, Boudet, José Miguel, Díaz, Gema, Sánchez-Migallón, Ana M., Casellas, Francesc
• Format: Article
• Language: English
• Subjects: Biologic therapies; Crohn's disease; Enfermedad de Crohn; Enfermedad inflamatoria intestinal; Inflamación; Inflammation; Inflammatory bowel disease; Terapias biológicas
• ISSN: 2444-3824; 2444-3824
• DOI: 10.1016/j.gastre.2021.04.007

No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI