Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Abstract

Background Recent data indicate that 5‐aminosalicylic acid (5‐ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrolment. Aim To evaluate the efficacy of oral 5‐ASA treatment, started immediately after achieving steroid‐induced remission, in preventing clinical relapses of Crohn's disease. Methods Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5‐ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5‐ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. Results Final analysis included 117 patients (58 taking 5‐ASA and 59 taking placebo; follow‐up 9.2 ± 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5‐ASA patients and 31% and 52% in placebo patients, respectively (rate difference + 0.095; 95% CI = −0.085– + 0.274). Subgroups analysis showed that 5‐ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. Conclusions Contrary to previous results, in our study early introduction of treatment with oral 5‐ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.

Infliximab therapy in pediatric Crohn’s disease: a review

“…8 However, de Franchis and coworkers showed that once patients achieved disease remission on mesalamine, less than 50% of patients were able to sustain disease remission after one year of maintenance therapy. 9 Although studies have shown that corticosteroids are effective in inducing remission in patients with active CD, 10 not all patients respond favorably. And among those patients that respond to induction corticosteroids, 40% to 68% of patients will relapse within a year, while up to 36% of patients will develop corticosteroid dependency.…”

Maintenance Therapy in Crohn's Disease

“…Some clinical trials have suggested that mesalazine may be effective in certain subgroups of patients (eg, those in remission for only a short period of time), while others have shown that, overall, the treatment effect observed with mesalazine in patients with medically induced remission is minimal and not statistically significant (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). In patients who required glucocorticoids to control acute symptoms of Crohn's disease, mesalazine 4 g/day appeared to offer no therapeutic advantage over placebo (6).…”

Maintenance of Medically Induced Remission of Crohn’s Disease

“…The time to relapse was 119 days for the mesalazine-treated patients compared with 109 days for placebo-treated patients (nonsignificant). In an Italian multicenter study, de Franchis et al [24] treated patients with Crohn’s disease having achieved remission on steroids either with 5-ASA 3 g daily or placebo, while steroids were doubled over 6 weeks. In this study, 5-ASA did not prevent relapse in Crohn’s disease patients (relapse rate after 20 months was 58% in the 5-ASA group and 52% in the placebo group).…”