Study (LoE) | Trial | Systematic bDMARD withdrawal | Withdrawal from | Population (DMARD naïve) | Initial therapy | Clinical outcome after step-down | Radiographic outcome after step-down | Risk of bias | ||
---|---|---|---|---|---|---|---|---|---|---|
Detert et al (1b)39 | HIT HARD | Yes | Week 24 | Pts with ERA n=87 | ADA+MTX | DAS28 remission at week-48 | 42% | Week-48 mTSS | 2.6 | Low |
NA | n=85 | MTX+PBO | 37% | 6.4* | ||||||
Atsumi et al (1b)44 | C-OPERA | Yes | Week 52 | Pts with high risk† ERA n=108 | CZP+MTX | SDAI remission at week 104 | 41% | Percentage of patients with year 2 ΔmTSS ≥0.5 | 16% | Unclear‡ |
NA | n=71 | MTX+PBO | 29%* | 32%*** | ||||||
Hørslev-Petersen et al (2b)45 | OPERA | LDA only | Week 54 | Pts with ERA n=89 | ADA+MTX | DAS28CRP <2.6 at 24 months | 69% | Per centage of pts with year 2 ΔmTSS ≥1 | 84% | Low |
NA | n=91 | MTX+PBO | 66% | 80% | ||||||
Smolen et al (2b)46 | OPTIMA | LDA only | Week 26 | Pts with ERA n=102 | ADA+MTX | DAS28CRP <2.6 at 78 weeks | 66% | Percentage of pts with week78 ΔmTSS ≥0.5 | 81% | Low |
NA | n=112 | MTX+PBO | 68%** | 78% | ||||||
Emery et al (2b)43 | AVERT | LDA only | Week 54 | Pts with ACPA+ERA n=119 | ABA+MTX | DAS28-CRP <2.6 at 18 months | 18% | None | Low | |
Week 54 | n=116 | ABA+PBO | 12% | |||||||
NA | n=116 | MTX+PBO | 9%* |
p Value for comparison bDMARD+MTX versus MTX *<0.05; **<0.01; ***<0.001.
†High-risk ERA defined as high titres of ACPA/RF or erosions.
‡Abstract only.
ACPA, anticitrullinated protein antibody; ADA, adalimumab; CZP, certolizumab-pegol; DB, double-blind; ERA, early rheumatoid arthritis; LDA, low disease activity; LoE, level of evidence; MTX, methotrexate; NA, not applicable; pts, patients; RF, rheumatoid factor; SJC, swollen joint count; SSZ, sulfasalazine; ΔmTSS, variations in modified total Sharp score.