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P658 Efficacy and safety of thalidomide in adults with refractory Crohn’s disease to maintain clinical remission: a retrospective cohort study

L. Lin*1, Z. Huang1, K. Chao1, X. Gao1

1The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China

Background

Thalidomide is effective in inducing clinical remission in children and adolescents with refractory Crohn’s disease (CD). However, the efficacy and safety of thalidomide in adult patients with refractory CD to maintain clinical remission remain unclear.

Methods

Seventy-nine consecutive adult CD patients in remission, who were refractory or intolerant to thiopurines and dependent on steroid before, were retrospectively enrolled. Thalidomide (50–100 mg/day) was administrated to maintain clinical remission. Patients who were induced by other immunosuppressants before would continue the concomitant therapy in low dose. Primary outcome was the time of clinical relapse that defined as the Harvey–Bradshaw Index (HBI) scores >4. Mucosal healing after thalidomide treatment was defined as simplified endoscopic activity scores for CD (SES-CD) = 0.

Results

By Week 48, the clinical remission rate was 70.89% out of all the 79 patients. Normalisation of high-sensitivity C-reactive protein levels (hs-CRP) at baseline (adjusted relative risk, 5.209; 95% CI, 1.402–19.349; p = 0.014) predicted the efficacy of remission maintenance (Figure 1). Forty-four patients consented to undergo colonoscopy at the time before and after thalidomide treatment. The mucosal healing rates after thalidomide treatment was 14.63% (Figure 2). Adverse events occurred in 54 (68.35%) patients, but only 8 (10.13%) patients had to discontinue therapy. None of the side effect was irreversible.

Proportion with remission in patients that stratified by the normalisation of hsCRP levels at baseline. p-value and RR were calculated for comparison between two groups in Log-Rank test and Cox proportional hazard model, which were adjusted for disease duration and disease behavior.

Colonoscopies of patients who got mucosal healing after thalidomide therapy. 1A, 2A, and 3A were three patients' colonoscopies before treatment. 1B, 2B, and 3B were the patients' colonoscopies after thalidomide treatment, respectively.

Conclusion

Low-dose thalidomide was efficacious in maintaining clinical remission in 48 weeks and achieving mucosal healing in adult patients with refractory CD. The patients with normal hs-CRP levels at baseline may have a longer duration of clinical remission maintenance. The side effects of thalidomide were mild, tolerable, and reversible. Therefore, thalidomide may be an alternative candidate for adult refractory CD patients.