Table 1.
Methodology of trials about the effect of biological treatment on absenteeism and presenteeism.
| Author | Study Design | Treatment | n | Stage of RA | Age Range (Mean) | Disease Duration (Mean) | Absenteeism Measure | Presenteeism Measure | Method | Time Points |
|---|---|---|---|---|---|---|---|---|---|---|
| RCT Trials | ||||||||||
| Allaart 2007 [22] | RCT (BeST) | 1. Seq. monotherapy | 508 | Early RA (ACR criteria) | ≥18 (ND) | ND | Three-monthly diary on work absenteeism | - | FCM | Baseline until 2 years |
| 2. Step-up comb. Therapy (INF) c | ||||||||||
| 3. Initial comb. Therapy (INF) d | ||||||||||
| 4. MTX + INF d | ||||||||||
| Anis 2009 [23] | RCT (COMET) | MTX | 100 | Early RA (ACR criteria) | ≥18 (45.1) | 8.9 months | Number of missed work days/WPAI | Reduced working time (in days)/WLQ | HCM | 0 and 12 months (weeks 12, 24, 36, 52) |
| ETA + MTX | 105 | ≥18 (45.4) | 8.6 months | Number of stopped work days f/WLQ | ||||||
| Observational Studies | ||||||||||
| Zhang 2008 [24] | Open-label, multicenter, phase IIIb study (CanAct) | ADA | 389 | Moderate to severe active RA (ACR criteria) |
(55.0) | 12.5 years | Number of absent work days multiplied by the individual’s daily wage |
Number of extra work hours patients needed to catch up on tasks they were unable to complete during normal working hours multiplied by the individual’s hourly wage |
HCM | Baseline and 12 months |
| Augustsson 2010 [25] | Observational (STURE register) | Anti-TNF (ETA, INF, ADA) | 594 | ND | 18–55 years (40.0) | 9.4 years | - | Hours worked/week | ND | Baseline, 6 months, 1, 2, 3, 4, and 5 years |
| Hone 2013 [26] | Prospective, observational study | ETA | 204 | Moderate to severe RA | 20–67 (46.6) | 5.1 years | WPAI measures of absenteeism – work time missed | WPAI measures of presenteeism – impairment at work |
HCM | 6 months |
| Klimes 2014 [27] | Bottom-up cross-sectional cost-of-illness study | Without biologics | 137 | ND | 18–64 years (58.9) | 13.6 years | Days spent on sick leave, and the period of time spent on full disability pension or partial disability pension | - | FCM | 6 months |
| With biologics | 124 | 18–64 years (53.6) | 15.5 years | |||||||
| DMARDs | 130 | (53.7) | 10.1 months | |||||||
| Tanaka 2018 [28] | Non-interventional trial for up-verified effects and utility (ANOUVEAU) study |
ADA i | 1 196 | Greater portion of the patients had established RA, with moderate disease activity |
PW: (50.0) | 5.6 years | WPAI measures of absenteeism—work time missed | WPAI measures of presenteeism—impairment at work |
HCM | 48 weeks |
CZP—certolizumab pegol, ADA—adalimumab, DMARD—disease modifying antirheumatic agent, ETA—etanercept, IFX—infliximab, MTX—methotrexate, RCT —randomized clinical trial, ND—no data, NA—not applicable, OWI—overall work impairment, AI—activity impairment, RTX—rituximab, PW—paid worker employed for ≥35 h/week; PTW—part time worker employed for <35 h/week; HM—home maker non-employed; HCM—human capital method, FCM—friction cost method; ACR—American College of Rheumatology; RA—rheumatoid arthritis; WPAWork Productivity and Activity Impairment; (a) to be eligible for treatment with infliximab or etanercept, patients had to have a diagnosis of RA according to clinical judgment and have failed to respond to, or to be intolerant of, at least two DMARDs, including methotrexate; (b) MTX, next steps sulfasalazine, leflunomide, MTX + infliximab, gold, MTX + cyclosporine + prednisone, azathioprine + prednisone; (c) MTX, next steps add sulfasalazine, then hydroxychloroquine, then prednisone, next switch to MTX + infliximab, MTX + cyclosporine + prednisone, leflunomide, gold, azathioprine + prednisone; (d) starting with MTX + sulfasalazine + a tapered high dose of prednisone, next step MTX + cyclosporine + prednisone, next MTX + infliximab, leflunomide, gold, azathioprine + prednisone; (e) starting with MTX + infliximab, next steps sulfasalazine, eflunomide, MTX + cyclosporine + prednisone, gold, azathioprine + prednisone; (f) using mapping methods; (g) the COBRA-light strategy comprises high-dose methotrexate (25 mg/day), combined with medium-dose prednisolone (30 mg/day, tapered to 7.5 mg/day); (h) it comprises a combination of low-dose methotrexate (7.5 mg/day) and sulfasalazine (2 g/day) and initial high dose prednisolone (60 mg/day, tapered to 7.5 mg/day); (i) patients were eligible for the study if they had an inadequate response to conventional therapy (e.g., conventional DMARDs or biologics other than ADA) as stated in the current Japanese labelling recommendations for ADA and met the Japanese guidelines issued by the Japan College of Rheumatology for the use of TNF inhibitors