Table 18Radiographic joint damage in biologic DMARDs versus oral DMARD studies

StudyStudy Design
N
Duration
Population With Early RA (<3 years)Comparison (dose)Radiographic Outcomes
Adalimumab vs. Oral DMARD
Breedveld et al., 200676, *Hoff et al., 2009190
PREMIER study
RCT
799
2 years
Yes; MTX-naive patients with early, aggressive RAADA (40 mg biweekly) vs. MTX (20 mg/week)Total modified Sharp score change: 5.5 vs. 10.4; P<0.001
Erosion score change: 3.0 vs. 6.4; P<0.001
Joint space narrowing score change: 2.6 vs. 4.0; P<0.001
Etanercept vs. Oral DMARD
Bathon et al., 2000;77 Genovese et al., 2002;188 Genovese et al., 2005189
ERA study
RCT
632 (512)
12 months (1 year open-label extension)
Yes; MTX-naive patients with early, aggressive RAETN (10 or 25 mg twice weekly) vs. MTX (20 mg/week)Total Sharp score change: 1.0 vs. 1.59; P= 9,111
Erosion score change: 0.47 vs. 1.03; P=0.006
Klareskog et al., 200486
van der Heijde et al., 2006136
van der Heijde et al., 2006138
TEMPO study
RCT
686 (503 for 2-year results)
52 weeks (2 years, 100 weeks)
NoETN (25 mg twice weekly) vs. MTX (7.5 titrated to 20 mg/week)At 1 year:
Total modified Sharp score change: 0.52 vs. 2.80; P=0.047
Erosion score change: 0.21 vs. 1.68; P<0.008
Joint space narrowing score change: 0.32 vs. 1.12; P=NR (NS)
*

New study added since last review.

ADA = adalimumab; DMARD = disease modifying antirheumatic drug; ERA = early rheumatoid arthritis; ETN = etanercept; INF = infliximab; LEF = leflunomide; mg = milligram; MTX = methotrexate; NR = not reported; P=NR (NS), p value not reported but authors stated it was not significant; RA = rheumatoid arthritis; RCT = randomized controlled trial; TCZ = tocilizumab; TEMPO = Trial of etanercept and Methotrexate with radiographic patient outcomes; vs. = versus

From: Results

Cover of Drug Therapy for Rheumatoid Arthritis in Adults: An Update
Drug Therapy for Rheumatoid Arthritis in Adults: An Update [Internet].
Comparative Effectiveness Reviews, No. 55.
Donahue KE, Jonas DE, Hansen RA, et al.

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