Infliximab switch to Adalimumab in Crohn
Related articles (Crohn):
*Methotrexate in Crohn
*Infliximab in Crohn (ACCENT I)
*Infliximab with Azathiopurine (Crohn)
*Infliximab with Methotrexate (Crohn)
*Adalimumab (CLASSIC & CHARM trial – Crohn)
*Adalimumab with immunomodulator (Crohn)
*Ustekinumab (UNITI trial – Crohn – 2016)
*Vedolizumab (GEMINI II – Crohn – 2013)
Background and Aims:
In the 4-week GAIN clinical trial, adalimumab was efficacious in inducing remission in patients with moderate-to-severe Crohn’s disease [CD] who had prior loss of response/intolerance to infliximab. The efficacy and safety of adalimumab in these patients are reported here for up to 96 weeks or for 3 years, respectively, in the ADHERE open-label extension study.
Patients who completed GAIN could enrol in ADHERE and receive open-label adalimumab 40 mg every other week. Efficacy variables included clinical response (Crohn’s Disease Activity Index [CDAI] decrease from baseline ≥70/≥100 points [CR-70/CR-100]) and remission [CDAI<150], steroid discontinuation and fistula remission [absence of drainage]. Data were reported using hybrid non-responder imputation [hNRI], last observation carried forward and as-observed analysis. Subgroup analyses were performed by randomized group in GAIN and by Week 4 efficacy in GAIN. Safety was also assessed.
A total of 310 patients from GAIN enrolled in ADHERE. CR-70, CR-100 and remission rates at Week 96 were 39.0%, 35.5%, and 26.5% [hNRI], respectively. Of the patients with CR-70 response or remission at Week 4 of GAIN, 45.5% and 44.4% [hNRI], respectively, maintained the effect at Week 96. Steroid discontinuation and steroid-free remission rates increased from Week 12 to 96 in patients using corticosteroids at GAIN baseline.
Long-term adalimumab maintenance therapy led to sustained clinical remission and response, and steroid discontinuation in a considerable proportion of patients with CD previously treated with infliximab. No new safety signals were observed in this patient population.
Panaccione R, Sandborn WJ, D’Haens G, et al. Clinical benefit of long-term adalimumab treatment in patients with Crohn’s disease following loss of response or intolerance to infliximab: 96-week efficacy data from GAIN/ADHERE Trials. J Crohns Colitis 2018;12:930–8.