Colchicine versus placebo in Behçet’s disease: randomized, double-blind, controlled crossover trial

Abstract

The effect of colchicine was evaluated in a large cohort of Behçet's disease (BD) patients and compared to placebo. In a randomized, double-blind, controlled crossover trial, 169 patients without major organ involvement were selected consecutively. They fulfilled the International Criteria for Behçet's Disease. Patients were randomly assigned to colchicine or placebo. At 4 months, they were swapped over (colchicine to placebo, placebo to colchicine) for another 4 months. The primary outcome was the overall disease activity index, the IBDDAM. The secondary outcome was the responses of the individual symptoms. A Student's paired t test was used to evaluate results within each group, and an ANOVA to check for differences between colchicine and placebo. Analysis was performed using the "intention to treat" method. For placebo, IBDDAM worsened from 3.17 to 3.63 (t = 1.750, P = 0.08). For colchicine, IBDDAM improved from 3.35 to 2.75 (t = 4.143, P < 0.0001). Oral aphthosis, genital aphthosis, pseudofolliculitis, and erythema nodosum improved significantly with colchicine but not with placebo. According to the ANOVA, the difference in IBDDAM between colchicine and placebo was highly significant (F = 14.674, P = 0.00016). The difference between the results for males and females was not significant (F = 0.181, P = 0.67). In conclusion, colchicine, but not placebo, significantly improved the overall disease activity index. The difference between the results for colchicine and placebo was also statistically significant.

Update on the therapy of Behçet disease

“…In the third randomized, doubleblind, placebo-controlled crossover trial, 169 patients with BD without major organ involvement were selected consecutively. The overall disease activity as well as the oral and genital aphthosis, pseudofolliculitis, and erythema nodosum improved significantly with colchicine but not with placebo [Davatchi et al 2009].…”

Behçet's disease: A comprehensive review with a focus on epidemiology, etiology and clinical features, and management of mucocutaneous lesions

“…In the treatment of OU, GU, EN-like lesions and PPL, colchicine should be the first choice. [91][92][93] If this is not effective, colchicine can be combined with benzathine penicillin. 94,95 Shortterm corticosteroids in combination with other drugs such as colchicine can be used as an alternative in the treatment of acute attacks of OU, GU, EN-like lesions and superficial 100 and rebamipide 101 can be other choices, however, there is still a need for well-organized newer studies of these agents.…”

Mediterranean fever (<i>MEFV</i>) Variant <i>P369S/R408Q</i> in a Patient with Entero-Behçet's Disease who Successfully Responded to Treatment with Colchicine

“…Immunosuppressive therapy, such as corticosteroids, azathioprine and tumor necrosis factor (TNF)α antagonists, is used empirically to treat entero-BD. Colchicine is useful for treating arthritis, genital ulcers and erythema nodosum, which may present in BD patients (20); however, there are few reports showing the usefulness of colchicine in cases of gastrointestinal involvement (21). Colchicine acts by mediating the assembly of the NOD-like receptor family, pyrin domain containing 3 (NLRP3) inflammasome via the inhibition of microtubules (22) and has been reported to be effective in over 90% of FMF patients (23).…”