Table 10Summary of efficacy trials in adult patients with ankylosing spondylitis

Author YearStudy designNDurationComparisonsPrimary outcomeSecondary outcomesPopulationResultsQuality rating
ADALIMUMAB
McLeod et al., 2007157SR and MA39712 weeksAdalimumab/placeboASAS 20% improvement at 12 weeksASAS 50/70, BASDAIAdults with ASResponse rates on ASAS 20/50/70 were statistically significantly greater for adalimumab than for placeboGood
ETANERCEPT
McLeod et al., 2007157SR and MA60212–24 weeksEtanercept/placeboASAS 20% improvement at 12 weeksASAS 50/70, BASDAIAdults with ASResponse rates on ASAS 20/50/70 were statistically significantly greater for adalimumab than for placeboGood
Barkham et al., 2010158RCT4012 weeksEtanercept (25 mg twice weekly) + standard treatment vs. placebo + standard treatmentChange in work instability (AS-WIS)BASDAI, ASQoL, BASFI, work participationAdults with AS and work unstableNo statistically significant differences in work instability of QoL between etanercept and placeboFair
Dougados et al., 2011159RCT8312 weeksEtanercept 50 mg once weekly vs. placeboVAS, BASDAI, BASFI, BASMIPulmonary function testsAdults with ASImprovement in BASDAI statistically significantly greater for etanercept than placeboFair
GOLIMUMB
Inman et al., 2008160RCT35614 weeksGolimumab 50 mg every four weeks, golimumab 100 mg every two weeks vs. placeboASA20ASAS40, ASAS5/6, BASDAI, BASFI, back pain, night pain, sleep disturbance, QoLAdults with ASResponse rate on ASA20 and BASDI50% statistically significantly better in golimumab compared with placeboFair
INFLIXIMAB
McLeod et al., 2007157SR and MA348VariousInfliximab/placeboASAS 20% improvement at 12 weeksASAS 50/70, BASDAIAdults with ASResponse rates on ASAS 20//50/70 were statistically significantly greater for infliximab than for placeboGood
Inman et al., 2010161RCT7612 weeksInfliximab 3 mg/kg (low dose) vs. placeboASA20ASAS40, ASAS50, ASAS70, BASDAI, BASFI, BASMI, QoLAdults with ASResponse rates on ASAS 20//50/70 were statistically significantly greater for infliximab than for placeboFair

Abbreviations: AS, ankylosing spondylitis; ASAS 20/50/70, Assessment in Ankylosing Spondylitis 20/50/70% improvement; AS-WIS: Ankylosing Spondylitis Work Instability Scale; BASDAI, Bath AS Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; MA, Meta-analysis; QoL, quality of life; RCT, randomized controlled trial, SR; Systematic Review.

From: RESULTS

Cover of Drug Class Review: Targeted Immune Modulators
Drug Class Review: Targeted Immune Modulators: Final Update 3 Report [Internet].
Thaler KJ, Gartlehner G, Kien C, et al.
Portland (OR): Oregon Health & Science University; 2012 Mar.
Copyright © 2012, Oregon Health & Science University, Portland, Oregon.

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