Infliximab therapy in patients with AS: an open label 12 month study

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Ann Rheum Dis. 2003 Dec;62(12):1218-20.

Infliximab therapy in patients with ankylosing spondylitis: an open

label 12 month study.

Temekonidis TI, Alamanos Y, Nikas SN, Bougias DV, Georgiadis AN,

Voulgari PV, Drosos AA.

Division of Rheumatology, Department of Internal Medicine, Medical

School, University of Ioannina, Ioannina, Greece.

OBJECTIVE: To evaluate the efficacy and safety of long term infliximab

therapy in patients with severe refractory ankylosing spondylitis (AS).

PATIENTS AND METHODS: Twenty five patients (24 male, 1 female; mean (SD)

age 36.0 (10.5); disease duration 13.8 (8.5) years) with AS fulfilling

the modified New York criteria for AS were investigated. Twenty two

(88%) patients were HLA-B27 positive. All patients had active axial

disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

>/=30/100) and C reactive protein (CRP) >/=10 mg/l, despite adequate

treatment. Intravenous infliximab (5 mg/kg) was given at weeks 0, 2, 6,

and every eight weeks thereafter for 12 months. The primary end point

was the reduction of the patient's global assessment of pain (GAP) by

>20% on a 100 mm visual analogue scale. RESULTS: GAP was reduced by >20%

in 23 (92%) patients, by 50% in 21 (84%) patients, and by 70% in 13

(52%). The change in BASDAI and CRP from baseline was statistically

significant. The treatment was well tolerated with minimal side effects.

One patient dropped out owing to inefficacy and one stopped treatment

owing to an allergic reaction.

CONCLUSION: This longer length study confirms the efficacy of infliximab

and the good safety profile in patients with AS.

Publication Types:

a.. Clinical Trial

PMID: 14644863

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