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Infliximab Improves Symptoms of Ankylosing Spondylitis Over a 1-Year Period

In patients with ankylosing spondylitis (AS), infliximab appears to improve symptoms and results in a durable response for a 1-year period, new research suggests.

Infliximab is a monoclonal antibody to tumour necrosis factor alpha and a disease-modifying antirheumatic drug (DMARD). DMARDs are currently not approved for the treatment of AS. However, treatment of AS with infliximab was shown to be efficacious in patients with active disease during a previous 3-month clinical trial. In that trial, benefits were seen for disease activity, function, spinal motility, peripheral arthritis, enthesitis, and quality of life.

William Braun, MD, with the Benjamin Franklin Hospital, Free University, Berlin, Germany, and colleagues evaluated the efficacy and safety of infliximab treatment of AS for a 1-year period in an open, observational, extension study of the 3-month trial.

All 65 patients who had tolerated infliximab (infliximab/infliximab group) or placebo (placebo/infliximab 12-week crossover group) therapy for 3 months entered the open extension trial.

Infliximab was administered at a dosage of 5 mg/kg every 6 weeks after the induction phase (weeks 0, 2, and 6). The primary end point was a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

At week 54, 54 of the 69 patients (78%) continued to take infliximab. Of those, 47% of patients in the infliximab/infliximab group and 51% of the patients in the placebo/infliximab group achieved a 50% improvement in BASDAI scores.

Among patients who completed the study, the mean BASDAI scores improved between weeks 0 and 54 from 6.6 to 2.4 in the infliximab/infliximab group and from 6.3 to 2.6 in the placebo/infliximab group. Furthermore, about 70% of the patients were able to decrease dosage of nonsteroidal anti-inflammatory drugs. Measures of functioning, metrologic parameters, and quality of life also improved significantly.

Between weeks 12 and 54, 4 patients experienced serious adverse events possibly related to infliximab use and discontinued the study. Most frequent adverse events were upper respiratory tract infection, Headache, and abnormal/elevated transaminase levels.

"This study underscores a pathogenetic role of tumour necrosis factor alpha in AS and portends a paradigm shift in the expectations for pharmacotherapy of AS," the researchers suggest.

"Further studies are needed to assess the efficacy of infliximab on structural changes, as assessed by magnetic resonance imaging and radiographic techniques," they note. "The continued observation of this AS cohort, including comparisons of radiographs of the spine taken before and after infliximab therapy at 2 years, is ongoing."

Arthritis Rheum 2003 Aug;48:8:2224-33. "Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: An open, observational, extension study of a three-month, randomized, placebo-controlled trial"

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