Induction of remission by interferon-alpha in patients with chronic active ulcerative colitis

Abstract

Objective: To ascertain whether treatment with interferon-alpha 2a (IFN-alpha 2a) can induce remission in patients with chronic active ulcerative colitis.

Study design: Prospective, open-label study.

Setting: The gastroenterology section of Ankara University School of Medicine, which is the regional referral centre for the city of Ankara.

Study population: The study included 28 in-patients with established ulcerative colitis and lacking known pathogens. The diagnosis was confirmed using endoscopic, radiological and histological techniques. Patients enrolled in the study had previously shown resistance to 5-aminosalicylic acid and steroids.

Measurements: Disease activity was evaluated clinically and endoscopically. Laboratory parameters (erythrocyte sedimentation rate, haematocrit, and serum albumin levels) were used as indirect markers of inflammatory status. After a 10 day washout period, patients were treated with IFN-alpha 2a.

Intervention: IFN-alpha 2a therapy started with 3 MIU (one subcutaneous injection) and was increased to 6 MIU (one subcutaneous injection) and then 9 MIU three times a week (three subcutaneous injections every second day for 1 week) to habituate the patients and ensure early onset of action. The dose was then decreased to 6 MIU (three injections every second day for 1 week) and maintained at 3 MIU (three times a week) for 6-12 months.

Results: Clinically, 71% per cent of the patients had severe and 29% moderate ulcerative colitis activity before the treatment. Five patients (18%) did not respond to IFN-alpha 2a therapy within the first 2 months; two of them underwent total colectomy and the remaining three (11%) achieved late remission after prolonged IFN-alpha 2a therapy. Twenty-three (82%) patients responded to therapy with a fast improvement (within 15 days) and were in complete clinical and endoscopic remission after 6 months of therapy. During the treatment period, four (14.2%) patients with pre-existing small haemorrhoids suffered from enlarged ulcerated and bleeding external haemorrhoids, and flu-like symptoms were a common side effect. No adverse effects serious enough to necessitate discontinuation of the therapy were observed. Twenty-six (93%) patients were observed for more than 2 years without being given therapy and remained in full clinical and endoscopic remission during this period.

Conclusion: In our opinion, IFN-alpha 2a is a well-tolerated, non-toxic, easily applicable and outstanding drug, which could become the treatment of choice for first-line therapy of chronic active ulcerative colitis, especially in patients who show resistance to other drugs.