Biological DMARD strategy studies* with a treat-to-target approach—study outcomes
| Biological DMARD | Study (n=total number enrolled) | Outcome | Result |
|---|---|---|---|
| ADA | Heimans 2013 (IMPROVED)17 (n=610) | Primary EP: | Groups: MTX+high dose prednisolone (early DAS remission arm); MTX+HCQ+SSZ; MTX+ADA† |
| 1 year DAS44 remission (DAS<1.6): | 68% ; 25% vs 41% (MTX+HCQ+SSZ vs MTX+ADA p<0.001) | ||
| 1 year DFR remission | 32%; 1% vs 0% | ||
| Other: | |||
| ΔmTSS<0.5 | 95%; 96%; 92%; | ||
| Horslev–Petersen 2013 (OPERA)53 (n=180) | Primary EP: | Groups: ADA+MTX vs Placebo+MTX | |
| 1 year DAS28CRP<3.2 | 80% vs 76% (p=0.65) | ||
| Other: | |||
| 1 year DAS28CRP (median (95% CI) | 2.0 (1.7 to 5.2) vs 2.6 (1.7 to 4.7) (p=0.009), | ||
| 1 year DAS 28 remission (DAS28<2.6) | 74% vs 49% (p=0.0008), NNT 4.0 (2.6–9.1) | ||
| van Eijk 2012 (STREAM)58 (n=82) | Primary EP: | Groups: aggressive vs conventional care | |
| 2 year median (IQR) ΔmTSS§ | 0 (0–1.1) vs 0.5 (0–2.5) NS | ||
| Other: | |||
| 2 year median remission (DAS<1.6) | 66% vs 49% NS | ||
| ETN | Villeneuve ACR 2011 (EMPIRE)57 (n=110) | Primary EP: | Groups: ETN+MTX vs Placebo+MTX |
| 1 year remission (NTSJ at week 52) | 31% vs 29% (p=0.835) | ||
| IFX | Leirisalo–Repo 2012 (NEO-RACo)52 (n=99) | Primary EP: | Groups: FIN-Raco+IFX vs FIN-Raco+Pla‡ |
| 2 year modified ACR remission | 66% vs 53% (p=0.19) | ||
| Other: | |||
| 2 year sustained modified ACR remission¶ | 26% vs 10% (p=0.042) | ||
| DAS28 remission | Both groups: 82% (NS) | ||
| 2 year mean ΔmTSS§ | −0.2 vs 1.4 (p=0.0058) | ||
| 2 year radiographic non-progression | 80% vs 53% (p=−0.006) | ||
| Nam 2013 (IDEA)54 (n=112) | Primary EP: | Groups: IFX+MTX vs IV steroid (methylprednisolone)+MTX | |
| 1 year ΔmTSS score (mean) | 1.20 vs 2.81 (adjusted difference (95% CI) −1.45 (−3.35 to 0.45); p=0.132) | ||
| Radiographic non-progression (mTSS<2.0) | 81% vs 71% (OR 1.77 (0.56, 5.61); p=0.328) | ||
| Other: | |||
| 1 year DAS44 remission | 49% vs 36% (OR 2.13 (0.91, 5.00); p=0.082) | ||
| 1.5 year (week 78) DAS44 remission | 48% vs 50% (OR 1.12 (0.47, 2.68); p=0.792) |
*All DMARD-naive.
†IMPROVED comparator arms: All patients treated with MTX+high-dose oral prednisolone. Those that achieved early remission (DAS<1.6 at 4 months): tapered prednisolone and persistent remission after 8 months tapered and stopped MTX. Those not in early remission were randomized to MTX+HCZ+SSZ (arm 1) or MTX+ADA (arm 2). For those in remission after 8 months, treatment was tapered to MTX monotherapy; for those not in remission: arm 1 changed to MTX+ADA and arm 2 increased ADA dose.
‡NEO-RACo: FIN-Raco+Pla=MTX+SSZ+HCQ+prednisolone+placebo for 26 weeks; FIN-Raco+IFX=MTX+SSZ+HCQ+prednisolone+IFX 3 mg/kg for 26 weeks.
§mTSS=van der Heijde-modified total Sharp score.
¶Sustained remission=remission at each visit from 6 to 24 months.
ADA, adalimumab; DAS, disease activity score (44 joint count); DFR, drug-free remission; ETN, etanercept; IFX, infliximab, LDA, low disease activity, MTX, methotrexate; NS, non-significant; NTJ, no tender or swollen joints (RAI+SJC=0); primary EP, primary endpoint.