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STEPHANIE KEELING, ANNA OSWALD, CATHERINE MALLON, ANTHONY S. RUSSELL, and WALTER P. MAKSYMOWYCH

ABSTRACT.

Objective. Although there are now compelling data that infliximab is effective for the treatment of AS, most studies have evaluated a dose of 5 mg/kg rather than the 3 mg/kg dose recommended for patients with RA. We assessed the effectiveness and safety of a 3 mg/kg dose of infliximab in normal clinical practice over several years of followup.

Methods. All consecutive patients with AS starting infliximab therapy at 3 mg/kg IV at 0, 2, and 6 weeks and q 2 months between April 2000 and December 2004 were included. Data were systematically collected at baseline, at 14 weeks, and every 6 months thereafter to 4 years or withdrawal. Data included demographic characteristics, Bath AS indices, adverse events, and reasons for withdrawal. Survival taking low-dose infliximab was analyzed by the Kaplan-Meier method with withdrawal for lack of efficacy and/or adverse events and requirement for dose escalation constituting the endpoint.

Results. Thirty-four patients (M:F = 26:8), mean age 44.9 years, mean disease duration 17.1 years, and mean BASDAI of 6.4, were studied, of whom 17 had active peripheral synovitis. Median duration of treatment with low-dose infliximab was 1507 days. Fourteen discontinued therapy after a median of 91 days, 6 for adverse events, 6 for lack of efficacy, and 2 were lost to followup. Five (14.7%) patients required dose escalation. Effectiveness demonstrable at 1 year was maintained over 4 years. We did not identify any significant baseline predictors of maintenance on low dose infliximab for ≥ 2 years.

Conclusion. Low-dose (3 mg/kg) infliximab therapy is associated with sustained effectiveness in patients with AS in the real-world setting. (J Rheumatol 2006;33:558-61)

Key Indexing Terms:

ANKYLOSING SPONDYLITIS
INFLIXIMAB
TREATMENT

From the Department of Medicine, University of Alberta, and the Capital Health Authority, University of Alberta Hospital, Edmonton, Alberta, Canada.

S. Keeling, FRCPC, Assistant Professor; A. Oswald, FRCPC, Fellow; C. Mallon, Clinician Nurse, Capital Health Authority, University of Alberta Hospital; A.S. Russell, FRCPC, Professor, Department of Medicine, University of Alberta; W.P. Maksymowych, FRCPC, Professor of Medicine, Department of Medicine, University of Alberta.

Address reprint requests to Dr. W.P. Maksymowych, 562 Heritage Medical Research Building, University of Alberta, Edmonton, Alberta, Canada T6G 2S2.

Accepted for publication November 2, 2005.