Infliximab Dose Reduction Sustains the Clinical Treatment Effect in Active HLAB27 Positive Ankylosing Spondylitis: A Two-Year Pilot Study

Boel Mörck,Helena Forsblad-D'Elia,Tomas Bremell,Mats Geijer,Rille Pullerits

doi:10.1155/2013/289845

Boel Mörck, Helena Forsblad-D'Elia + Show 3 more

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https://doi.org/10.1155/2013/289845

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Abstract

The rationale of the study was to evaluate the efficacy of infliximab (IFX) treatment in patients with ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension sustains the treatment effect. Nineteen patients were included and treated with IFX 5 mg/kg every 6 weeks for 56 weeks. All patients concomitantly received MTX with median dose 7.5 mg/weekly. During the second year, the IFX dose was reduced to 3 mg/kg every 8 weeks. Eighteen patients completed the 1-year and 15 patients the 2-year trial. The ≥50% improvement at week 16 from baseline of BASDAI was achieved in 16/19 (84%) patients. Significant reductions in BASDAI, BASFI, and BASMI scores, decrease in ESR and CRP, and improvement in SF-36 were observed at weeks 16 and 56. The MRI-defined inflammatory changes in the sacroiliac joints disappeared in 10/15 patients (67%) already at 16 weeks. IFX treatment effect was sustained throughout the second year after IFX dose reduction and interval extension. We conclude that IFX treatment is effective in well-established active AS and a dose reduction sustains the treatment effect. These observations are of clinical importance and open the opportunity to reduce the drug costs. This trial is registered with ClinicalTrials.gov NCT01850121.

Highlights

Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease that primarily affects the spine and sacroiliac joints
In the present pilot study, we evaluated the clinical effect of infliximab treatment (5 mg/kg) on disease activity, patients’ quality of life, and MRI-defined inflammatory changes in the sacroiliac joints in patients with HLA-B27 positive active AS
We explored whether the clinical treatment effect achieved with a standard dose of 5 mg/kg of infliximab every 6 weeks was maintained after a dose reduction to 3 mg/kg every 8 weeks

Summary

Introduction

Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease that primarily affects the spine and sacroiliac joints. The disease affects mostly young individuals in the third and fourth decade of their life and may have a major impact on their work ability, which is associated with increased costs to the patient and the healthcare system [3]. Compelling data is increasing indicating that infliximab is effective for treatment of AS, most randomized, placebo-controlled studies have evaluated a treatment dose of 5 mg/kg every 6 weeks. The need for dose escalation up to 5 mg/kg due to partial treatment effect has been reported highly varying in different study cohorts [13,14,15]. Dose escalation was necessary in 15% and 18% of patients as reported by Maksymowych et al [10] and Jois et al [14], respectively. In two other studies it was found that 61%–63% of patients required dose escalation [12, 15]

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