Table 1.
Summary of inclusion criteria for the systematic review and meta-analysis
Study design | Phase II or III prospective, randomized controlled trials with at least one treatment arm containing a bDMARD combination therapy or bDMARD monotherapy |
Population | Adult patients (≥18 years) meeting the ACR classification criteria for rheumatoid arthritis |
Previously treated with MTX or other DMARD | |
≤15% of patients previously treated with TNF-α inhibitors | |
Interventions | Any bDMARD licensed in the EU |
Studies needed to include at least one treatment arm of bDMARD in combination with a DMARD or as a monotherapy | |
No restrictions to drug dose or formulation, mode of delivery or duration of treatment | |
Comparators | DMARD (combination analysis) or placebo (monotherapy analysis) |
Other comparators where needed to connect the network or preserve randomization | |
Outcomes | ACR 20/50/70 response rate to treatment (defined as a 20%, 50%, or 70% improvement in the ACR score) |
Outcome reported between 12 and 30 weeks of follow-up | |
Language of publication | Non-English full-text papers were excluded, but English abstracts of non-English full-text papers were included |
Abbreviations: ACR, American College of Rheumatology; bDMARD, biological disease-modifying antirheumatic drug; DMARD, disease-modifying antirheumatic drug; MTX, methotrexate; TNF-α, tumour necrosis factor-alpha.