Randomized Trial of Pimecrolimus Cream plus Colchicine Tablets versus Colchicine Tablets in the Treatment of Genital Ulcers in Behçet’s Disease

Abstract

Background: Recurrent and painful genital ulcers are the hallmark of Behçet’s disease. Objective: To determine the efficacy of pimecrolimus (PIM) cream on the pain and healing time of genital ulcers. Methods: A total of 76 patients were randomized to either receive PIM cream plus colchicine (COL) tablets (1–2 g/day) or COL tablets (1–2 g/day) alone for 1 month. Clinical evaluations were performed in 68 patients at the baseline and on the 3rd, 7th, 10th, 14th and 28th days of treatment. Also, genital ulcer pain was evaluated using a verbal pain score at each visit. Safety was monitored through adverse event reporting and laboratory tests. Results: The mean healing time of genital ulcers was shorter in the PIM + COL group (4.2 ± 1.5 days) than the COL group (4.7 ± 1.8 days), without statistical significance (p = 0.399). Visual analog scale scores decreased in both groups significantly. Neither of the treatment modalities was found to be superior to the other; however, pain was relieved in 4.2 ± 0.5 days in PIM + COL group and in 5.5 ± 1.2 days in COL group in the intention to treat population (p = 0.023). Observed adverse events were transient. Conclusion: Compared to COL alone, COL + PIM cream shortens the pain duration without any significant effect on healing time.

Behçet’s syndrome: Facts and controversies

“…88 Variable results with other topical agents such as sucralfate, cyclosporin-A, and pimecrolimus cream have been summarized in more detail. [89][90][91] Although we have made more progress during the recent decades for controlling the eye, mucosa-skin, and joint disease, more formal controlled studies are urgently needed for the vascular, neurologic, and GI involvement associated with Behçet's syndrome.…”

New Evidence-Based Treatment Approach in Behçet's Disease

“…This compound binds to ulcerated tissue and forms a barrier and augments ulcer healing. Recent controlled studies suggest that pimecrolimus, a topical immunomodulator, twice a day seems to be safe and efficient in the treatment of genital ulcers, by accelerating the healing process and shortening the pain duration [28, 29]. Amlexanox accelerate the healing and decreases the pain severity of oral ulcers.…”

The Anti-Inflammatory Drug Colchicine Lacks Efficacy in Hidradenitis Suppurativa

“…The plasma levels of colchicine should be monitored and the dose should be adjusted accordingly. In Behçet’s disease the addition of pimecrolimus cream increases the efficacy of colchicine, although not significantly [21]. It would be worthwhile to also investigate the addition of pimecrolimus cream to colchicine in HS in a randomized controlled trial.…”

“…Colchicine is a well-recognized valid therapy for gouty arthritis, FMF and Behçet’s disease [20,21]. Thus we hypothesized that colchicine could improve HS inflammation by reduction of inflammasome activity.…”