RELATIVE EFFICACY AND SAFETY OF USTEKINUMAB COMPARED TO ANTI-TNF-ALFA THERAPIES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Author(s)

Huszti Z
National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary

OBJECTIVES: Assess the relative efficacy and safety of ustekinumab compared to reimbursed anti-TNF-alfa therapies in patients with active psoriatic arthritis (PsA) METHODS: Randomized, placebo-controlled, at least 24-week-long, pivotal studies were searched in PubMed and EMBASE databases. Patients, participating in these trials, had active psoriatic arthritis. They were treated with DMARD and/or NSAID therapies and had not received any biological treatment before. Meta-analysis was based on ACR20, ACR50, ACR70, PASI75, HAQ-DI, AE and SAE endpoints. The quality assessment of evidences was based on EUnetHTA guidelines. For the applicability evaluation Aetkin’s method was used, while the meta-analysis used Frequentist approach. The mean and the 95% confidence interval of odd ratios (OR) were estimated with the Mantel-Haenszel test and with the fixed effect method. Statistical heterogeneity was tested using the Chi-squared-test, publication bias was checked with funnel plot. RESULTS: During the literature search 8 studies were identified. One study was excluded from the evaluation due to inadequate treatment dose. Due to altering placebo arm treatment and a high risk of bias at study level, two studies were involved in sensitivity analyses. Anti-TNF-alfa treatments had significantly better results on primary and accentuated secondary endpoints (ACR20 week 24 - ustekinumab vs. placebo: OR=2,56 (95%CI=1,74; 3,74); anti-TNF-alfa vs. placebo: OR=7,89 (95%CI=5,65; 11,1); ACR50 week 24 – ustekinumab vs. placebo: OR=3,46 (95%CI=1,94; 6,17); anti-TNF-alfa vs. placebo: OR=14,21 (95%CI=8,01; 25,23)). On the other secondary endpoints the differences were not significant, however results have shown subservient tendency for anti-TNF-alfa treatment against ustekinumab. During the safety comparisons we did not find a substantial difference between these treatments. CONCLUSIONS: Based on our evaluation the anti-TNF-alfa treatment appears more effective than ustekinumab in the first line biologic treatment of psoriatic arthritis.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PMS5

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Musculoskeletal Disorders

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