Table 3

Characteristics and results of studies eligible for meta-analysis reporting the impact of biological therapy on work participation in patients with axSpA

AuthorsYearStudy locationSampling frame*Study designAnalysis sampleSample size†Biological therapy (N)Control (N)Work measureReference period of work outcomesFollow-up
van der Heijde et al 27
(ASSERT)
2006USA, Canada, and Europe33 centres; adult patients with active AS according to mNYc.
Age: mean 39.8 (SD 10.2).
Phase 3, double blind, placebo controlled RCTEmployed patients only1229428Productivity VAS¶6 weeks12 months
Dougados et al 28
(EMBARK)
2015Latin America, Central Europe and AsiaMulticentre; adult patients (≥18 years), satisfied ASAS criteria with non-radiographic sacroiliitis defined as those who did not meet 1984 mNYc.
Age: 32.0 (7.8).
Phase 3, double blind, two-period RCTEmployed patients only1236063WPAI: SHP
AS-WIS
1 week3 months
Deodhar et al 29 (MEASURE-1)2016Americas, Europe and Asia65 centres; adult patients (≥18 years) who meet the mNYc for AS and BASDAI ≥4.
Age-biological: 40.1 (11.6).
Age-placebo: 43.1 (12.4).
Phase 3, double-blind, placebo-controlled RCT.Employed patients for WPAI (i)–(iii); full population for WPAI (iv).247125122WPAI: GH1 week4 months
Barkham et al 30 2010UKAdult patients with AS according to mNYc, BASDAI 2/3, VAS ≥40, early morning stiffness ≥45.
Age-biologic: 40.8 (9.7).
Age-placebo: 39.4 (10.1).
Double-blind, placebo-controlled RCTEmployed patients only402020AS-WIS3 months
BSRBR-AS study2017UKMulticentre; adult patients who are biological naïve; meet ASAS criteria for radiographic and non-radiographic axSpA.
Age-biological: 47.2 (13.9).
Age-non-biological: 53.9 (13.8).
Prospective, register-based dataEmployed patients only577161416WPAI: SHP1 week12 months
  • *Age: mean years (SD).

  • †Sample size of analysis.

  • ‡WPAI: (i) absenteeism; (ii) presenteeism; (iii) overall work impairment; and (iv) overall activity impairment.

  • Work Productivity and Activity Impairment: General Health.

  • AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis International Society; ASSERT, AS Study for the Evaluation of Recombinant Infliximab Therapy; AS-WIS, AS-Work Instability Scale; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSRBR-AS, British Society of Rheumatology Biologics register in Axial Spondyloarthritis; EMBARK, Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes (based on study title registered in NCT);  MEASURE 1, Effect of Secukinumab in Patients With Active Anklylosing Spondylitis; mNYc, Modified New York criteria; RCT, randomised controlled trial; VAS, visual analogue scale; WPAI: GH, Work Productivity and Activity Impairment: General Health; WPAI: SHP, Work Productivity and Activity Index: Specific Health Problem.