Background Efficacy and safety of etanercept 25 mg twice weekly was comparable to 50 mg once weekly in adult patients with ankylosing spondylitis (AS). We know that AS patient who were treated initially with Etanercept 25 mg twice weekly could be switched to once weekly but with increased dose per injection at 50 mg. Howeverrecent evidences suggest that etanercept 25 mg once weekly is effective enough to maintain remission for AS among korean patients. In addition discontinuation of etanercept 25 mg usually results in the relapse of disease activity but only after some weeks inAS patients in remission.
Objectives To evaluate if patients with AS in remission with biweekly etanercept therapy could be switched to an every-other-week regimen,without increased dose per injection.
Methods 38 patients with AS diagnosed at least from 1 year were enrolled, according to the modified 1984 New York Criteria for ASwith by minor to moderate radiographic evidence of spinal structural damage (Stage I-III). All patients had active AS (BASDAI>or=4), despite treatment with NSAIDs. Exclusion criteria included the presence of significant comorbidities, including active infection, cardiac insufficiency (NYHA class III/IV),malignancy, elevated liver enzymes, creatinine serum level >1,20 mg/l, alcohol and/or drug abuse, pregnancy, demyelinating diseases. Before being recruited for the study, patients were screenedfor latent tuberculosisandfor viral hepatitis. Patients meeting the inclusion and exclusion criteria self-administered 25 mg of etanercept (Wyett) subcutaneously twice weekly for sixteen weeks.According to the protocol,patient withclinical remission (defined as ASAS criteria and BASDAI<2) were switched to an weekly etanercept regimen without a change in dose at weeks 12 and 16 and to an every-other-week regimen at week 24. A follow-up was performed at week 36 and 48 to evaluate clinical efficacy.In case of a relapse of the disease activity etanercept 25 mg twice a week were administered again.
Results All patients received for 16 weeks a dose of 25 mg twice a week.The percentage of ASAS 20 responders was 81% (31 patients). Among them, 18 (47,3%)with persistent remission (week 12 and 16) were switched to an weekly regimen without a change in dose, while the other 13continued with biweekly etanercept therapy. At week 24, 15 patients (85%) were stable and among them 14 patients (93%) had clinical efficacy at week 36 and 54. At week 24, 3 patients (15%) did not show beneficial effects and they continued with etanercept 25 mg twice a week. There were no statistically significant differences in the incidence of adverse events between the biweekly etanercept therapy group (16 pt) and the every-other-week etanercept therapy group (14 pt). Baseline characteristics associated with a major clinical response to etanercept were a shorter disease duration, younger age, raised CRP and a higher BASDAI.
Conclusions Our study indicatesthat a consistent percentage of subjectswith AS (37%), differently from RA, treated with etanercept,maintains the remission also with an every-other-week regimen. Thisfinding may suggest that the AS patients in clinical remission with biweekly etanercept could be switched to an every-other-week regimen, without increased dose per injection, with relevant lowering of economic andsafety burden.
Disclosure of Interest None Declared
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