MedWire News: A scheduled infliximab strategy is an effective method for maintaining long-term clinical remission in patients with Crohn's disease and those with ulcerative colitis, and has a marked steroid-sparing effect, Italian study findings indicate.

Corticosteroids have been the cornerstone of therapy for patients with inflammatory bowel disease, but the adverse effects that emerge with long-term use exceed the clinical benefits, explain Renato Caviglia, from University Campus Bio-Medico in Rome, and colleagues.

Infliximab has therefore become an alternative choice for such patients, note the researchers, who sought to address some of the lingering safety concerns associated with the treatment. They reviewed the medical records of 40 patients with Crohn's disease and 10 with ulcerative colitis who received a loading dose of three infliximab infusions at 5 mg/kg, followed by scheduled re-treatments every 8 weeks.

Crohn's disease patients were treated for a median of 27 months, while those with ulcerative colitis were treated for a median of 24.5 months, the team reports in the World Journal of Gastroenterology.

A sustained clinical response or remission throughout the maintenance period was seen in 80% of Crohn's disease patients and 90% of ulcerative colitis patients. In all, three Crohn's disease patients had shortened intervals between infusion, while eight Crohn's disease patients and one ulcerative colitis patient underwent surgery for a disease flare-up.

Out of the 29 Crohn's disease patients and nine ulcerative colitis patients who discontinued infliximab scheduled treatment, nine and four, respectively, were relapse-free a median of 16 months and 6.5 months, respectively, after the last infusion.

At enrolment, 75% of Crohn's disease patients and 90% of ulcerative colitis patients required concomitant steroid therapy, which fell to 25% and 10%, respectively, during the maintenance period. Thirty two per cent of the overall group experienced at least one adverse event, and 6% were diagnosed with cancer during maintenance.

The researchers conclude: "The scrupulous selection of patients to be started on infliximab therapy is a fundamental issue, not only to obtain maximum efficacy, but also to avoid serious adverse events.

"A note of caution is mandatory when considering the possible risk of malignancy associated with the use of anti-tumor necrosis factor-alpha therapy. Further studies on larger series are needed to further clarify these important aspects."

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