Induction and maintenance of clinical remission by interferon-β in patients with steroid-refractory active ulcerative colitis—an open long-term pilot trial
Article first published online: 25 JUL 2002
Alimentary Pharmacology & Therapeutics
Volume 16, Issue 7, pages 1233–1239, July 2002
How to Cite
Musch, E. , Andus, T. and Malek, M. (2002), Induction and maintenance of clinical remission by interferon-β in patients with steroid-refractory active ulcerative colitis—an open long-term pilot trial. Alimentary Pharmacology & Therapeutics, 16: 1233–1239. doi: 10.1046/j.1365-2036.2002.01264.x
- Issue published online: 25 JUL 2002
- Article first published online: 25 JUL 2002
The imbalance of pro- and anti-inflammatory cytokines plays an important role in the pathogenesis of inflammatory bowel disease. Shifting this disturbed ratio by means of TNF-antibodies or interferon has been shown to be helpful in treating Crohn's disease and multiple sclerosis, respectively.
This pilot study investigated whether interferon-β can induce clinical remission in corticoid-refractory ulcerative colitis.
Twenty-five patients with steroid-refractory active ulcerative colitis (Clinical activity index according to Rachmilewitz: 13.5 ± 5.2) were treated in an open pilot trial with 0.5 MIU human natural interferon-β (hn-IFN-β) i.v. (n=18) or 1 MIU recombinant interferon-β-1a (r-IFN-β-1-a) s.c. (n=7) daily with the goal of induction of remission. Subsequent maintenance treatment was carried out for 52.0 ± 78.8 weeks (range 4–336 weeks) with the same dose, three times per week.
Twenty-two of 25 patients (88%) went into remission during induction treatment (hn-IFN-β 16/18, r-IFN-β-1a 6/7). Mean time to response was 3.0 ± 1.3 weeks. Mean length of remission was 13.0 ± 19.7 months. Only eight of 22 patients in remission relapsed during maintenance treatment. Five of these went into remission again after increasing the dose. Adverse events consisted of slight to moderate flu-like symptoms and slight to moderate hair loss in five of 15 female patients.
Although this open pilot study included only a small number of patients, the high response rate suggests that interferon-β may be a safe and effective treatment for steroid-refractory active ulcerative colitis.