Table 3.
Characteristics and results of studies eligible for meta-analysis reporting the impact of biological therapy on work participation in patients with axSpA
| Authors | Year | Study location | Sampling frame* | Study design | Analysis sample | Sample size† | Biological therapy (N) | Control (N) | Work measure | Reference period of work outcomes | Follow-up |
| van der Heijde et al
27
(ASSERT) |
2006 | USA, Canada, and Europe | 33 centres; adult patients with active AS according to mNYc. Age: mean 39.8 (SD 10.2). |
Phase 3, double blind, placebo controlled RCT | Employed patients only | 122 | 94 | 28 | Productivity VAS¶ | 6 weeks | 12 months |
| Dougados et al
28
(EMBARK) |
2015 | Latin America, Central Europe and Asia | Multicentre; 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 RCT | Employed patients only | 123 | 60 | 63 | WPAI: SHP AS-WIS |
1 week | 3 months |
| Deodhar et al 29 (MEASURE-1) | 2016 | Americas, Europe and Asia | 65 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). | 247 | 125 | 122 | WPAI: GH | 1 week | 4 months |
| Barkham et al 30 | 2010 | UK | Adult 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 RCT | Employed patients only | 40 | 20 | 20 | AS-WIS | – | 3 months |
| BSRBR-AS study | 2017 | UK | Multicentre; 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 data | Employed patients only | 577 | 161 | 416 | WPAI: SHP | 1 week | 12 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.