Effects of a combination treatment of an intensive rehabilitation program and etanercept in patients with ankylosing spondylitis: a pilot study

OBJECTIVE: To determine the effects of a combination treatment including rehabilitation and etanercept versus rehabilitation only, on function, disability, and quality of life in a group of patients with active ankylosing spondylitis (AS). METHODS: Nineteen patients with AS consecutively admitted to a rehabilitation inpatient clinic were enrolled. Patients first participated in an intensive rehabilitation program and after a 6-month interval started etanercept therapy. After 3 weeks, they started a combination of rehabilitation and etanercept. The primary outcome measure was an improvement of the Bath Ankylosing Spondylitis Functional Index (BASFI) defined as the difference (Delta) between the 2 measurements (beginning and end). The difference between the 2 measurements for the first rehabilitation program was expressed as Delta1 and for the second as Delta2; the comparison between Delta1 and Delta2 for each outcome measure was taken into account. Secondary outcome measures included an improvement in the Revised Leeds Disability Questionnaire (LDQ), anthropometric measures, EuroQol (EQ-5Dvas), and the 6 minute walking test (6-MWT). RESULTS: A statistically significant improvement was observed both for BASFI (Delta1 = -0.71 +/- 0.23; Delta2 = -1.19 +/- 0.36, p < 0.001) and for LDQ (Delta1 = -0.28 +/- 0.08; Delta2 = -0.46 +/- 0.17, p = 0.001). All anthropometric measures as well as 6-MWT were statistically improved. Finally, EQ5Dvas showed a statistically significant difference (Delta1 = 6.63 +/- 2.81; Delta2 = 20.26 +/- 4.89, p < 0.001). No adverse effects were seen during treatment with etanercept. CONCLUSION: This combination treatment seems to improve function, disability, and quality of life in patients with active AS.