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Therapeutics |

Olsalazine was not better than placebo in maintaining remission in inactive Crohn disease

Gurinder Luthra, MD; and P. Jay Pasricha, MD
[+] Article, Author, and Disclosure Information

*See Glossary.

P value calculated from data in article.

Sources of funding: Kabi Pharmacia (now Pharmacia Upjohn).

For correspondence: Dr. N. Mahmud, Trinity College Dublin, Dublin, Ireland. E-mail nmahmud@tcd.ie.

Ann Intern Med. 2002;136(3):92. doi:10.7326/ACPJC-2002-136-3-092
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Question: In patients with Crohn colitis or ileocolitis, is olsalazine more effective than placebo in maintaining remission?

Design: Randomized (unclear allocation concealment*), blinded (unclear),* placebo-controlled trial with 52-week follow-up.

Setting: 25 hospitals in 3 countries.

Patients: 328 patients who were ≥ 18 years of age and had Crohn colitis or ileocolitis in complete remission (Crohn disease activity index [CDAI] ≤ 150) for ≥ 1 month before randomization. Exclusion criteria were receipt of steroid, azathioprine, or other immunosuppressive therapy within 8 weeks of the start of treatment; antibiotic therapy ≥ 1 month; potential for pregnancy or lactation; clinically important hepatic or renal insufficiency; strictures causing obstruction; fistulae; oral or symptomatic anal Crohn disease; stoma or small-bowel disease other than terminal ileal disease; or hypersensitivity to salicylates. 327 patients (99.7%) (mean age 39 y, 54% women) received the study drugs and had follow-up data.

Intervention: Patients were allocated to olsalazine, 2 g daily (n = 167), or placebo (n = 161) for 52 weeks.

Main outcome measures: The primary outcome was relapse (CDAI score > 150). Adverse events were also assessed.

Main results: The groups did not differ for relapse {P = 0.49}† (Table). The study was powered to detect a difference in relapse rate of 15%. The failure rate (patients not completing the study) was higher in the olsalazine group than in the placebo group (P = 0.038) (Table). Adverse events were mild to moderate in severity, but occurred in more olsalazine than placebo recipients (P = 0.035) (Table).

Conclusion: In patients with Crohn colitis or ileocolitis, olsalazine was not better than placebo in maintaining remission.

Olsalazine vs placebo for Crohn colitis or ileocolitis at 52 weeks‡

OutcomesOlsalazinePlaceboRRI (95% CI)NNH (CI)
Relapse48.5%45.0%8.5% (−37 to 14)Not significant
Failure to complete study66%53%23% (3.1 to 48)9 (5 to 55)
≥ 1 adverse event39%28%42% (3.7 to 95)9 (5 to 84)

‡Abbreviations defined in Glossary; RRI, NNH, and CI calculated from data in article.





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