engleski

Efficacy and safety of adalimumab in patients with ankylosing spondylitis and total spinal ankylosis in Croatia: one year follow-up

Background: Patients with ankylosing spondylitis (AS) who develop total spinal ankylosis (TSA) experience more functional impairment and are at higher risk for serious complications (e.g. spinal fractures). They also might have more signs and symptoms of active disease (1) Objectives: To evaluate the efficacy and safety of adalimumab in patients with AS and TSA. Primary endpoint. The ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at week 12 and 52. Type of research. Multicenter, prospective. Methods: Nineteen patients (17 men, 2 women ; mean age 49.1 ± 11.2 years) diagnosed with AS according to the 1987 modified NY criteria and TSA were recruited from the databases of eight rheumatology departments in Croatia. All patients had active disease (BASDAI ≥ 4) and treated with adalimumab (40mg/bi-weekly) (2). A structured questionnaire containing demographic and clinical data was used. Following variables were evaluated at week 12 and 52: function using BASFI, disease activity using BASDAI, patient's and physician's global assessment of disease activity, total back pain and fatigue, all of them measured on visual analogue scale (VAS). Both efficacy and safety results are summarised descriptively. Results: Mean disease duration was 20.2± 11.6 years. Compared to baseline measures, there was a significant improvement in BASFI and BASDAI at week 52: BASFI (6.9 ± 1.19 and 3.13 ± 1.54, respectively) and BASDAI (6.8 ± 1.03 and 2.28 ± 1.45, respectively). Significant improvement was also seen at baseline and week 52 in other observed variables: patient's and physician's global assessment, total back pain and fatigue. At month 3 ASAS20 was reached in 18/19 patients and at months 12 in 17/19 patients. Injection site erythema was reported in 2 patients only at first months of the treatment. No serious side effects were observed during 12-month treatment with adalimumab. Conclusions: In our 12-month study adalimumab treatment of patients with AS and TSA resulted in clinically significant improvement regarding function and disease activity. No serious adverse side effects were reported in our cohort.

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