P343 Changing the coUrse of cRohn’s disease with an Early use of adalimumab: The CURE study from the GETAID
Peyrin-Biroulet, L.(1);Bouhnik, Y.(2);Laharie, D.(3);Elgharabawy, Y.(4);
(1)CHRU de Nancy, Gastroenterology, Nancy, France;(2)AP-HP. Nord-Université de Paris- Hôpital Beaujon, Gastroenterology, Clichy, France;(3)CHU Bordeaux Haut Lévèque, Gastroenterology, Pessac, France;(4)GETAID, Biostatistic, Paris, France; the CURE GETAID study group
Crohn's disease (CD) is a disabling and destructive disease. Early intervention associated with tight monitoring appear to the best way to achieve deep remission and to prevent disease progression. Whether anti-TNF therapy can be interrupted in patients with early CD who have undergone a period of prolonged deep remission is unknown. The primary objective was to evaluate the sustained deep remission rate one year after discontinuation of a 12-month course of adalimumab in adult patients with early CD who achieved deep remission at 12 months and who were already in clinical remission and biomarker remission at 6 months.
We carried out a multicentre prospective GETAID cohort study. All patients were naïve to biologics. The primary study endpoint was the percentage of patients with sustained deep remission at 2 years after a 12-month course of adalimumab in patients who achieved deep remission without therapeutic intervention (i.e. no surgery, no clinical flare-up, no introduction of CD-related treatment, no need for adalimumab optimization) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months.
The time to first relapse in patients who achieved deep remission after 12-month therapy was also evaluated.
A total of 201 subjects were included between March 2015 and March 2019. The median disease duration was 4 months.
Overall, 56/183 (30.6%) of patients achieved deep remission at one year. From those who achieved deep remission, not lost to follow-up (n=8) and without protocol violation (n=2), 20/46 (43.48%) maintained their deep remission for one year after their treatment discontinuation (month 24 of the study). Probabibility of relapse-free survival following adalimumab discontinuation in patients achieving deep remission at 12 months was 44.8% (Figure).
Three out of 10 patients with early CD and naïve to biologics achieved deep remission at one year with adalimumab. Among these patients, about half of them maintained deep remission at 2 years. The identification of factors associated with treatment success will allow identifying CD patients who can stop anti-TNF therapy after achieving deep remission.