Table 22Disease activity and remission for biologic DMARD+oral DMARD versus oral DMARD

StudyStudy Design
N
Duration
Study PopulationComparison (dose)ResultsQuality Rating
Abatacept+MTX vs. MTX
*Westhovens et al., 200989RCT
509
2 year (1 year reported)
Early RA, MTX-naïve or previous MTX ≤10 mg/week for 3 weeks or less, with none for prior 3 monthsAbatacept (~10 mg/kg)+MTX vs. MTXSignificantly higher ACR 50 response rates for ABA+MTX than MTX (57.4% vs. 42.3%; P<0.001)
Higher remission rates for ABA+MTX than MTX (41.4% vs. 23.3%; P<0.001)
Good
Adalimumab+MTX vs. MTX
Breedveld et al., 200676
PREMIER study
RCT
799
2 years
Early, aggressive RA; MTX-naive; mean disease duration NR (<3 years)ADA (40 mg biweekly)+MTX (20 mg/week) vs. MTX (20 mg/week)Significantly higher ACR 50 response rates for ADA+MTX than MTX (59% vs. 43%; P<0.001)Fair
Etanercept+MTX vs. MTX
*Emery et al., 200890; Emery et al., 201091
COMET study
RCT
542
52 weeks
2 years91
MTX-naïve patients; Early RA, mean disease duration 9 monthsETN (50 mg/week)+MTX 7.5 mg vs. MTXHigher ACR 20 response rates between ETN+MTX vs. MTX (86%, 67%, P<0.001)
Higher remission between ETN+MTX vs. MTX (50%, 28%, P<0.001)
Fair
Klareskog et al., 2004;86 van der Heijde et al., 2006;136 van der Heijde et al., 2006,138 *Kavanaugh et al., 2008192
TEMPO study
RCT
686 (503 for 2 year results)
52 weeks (2 years, 100 weeks)
Active RA; had failed at least 1 DMARD other than MTX; mean disease duration 6.6 yearsETN (25 mg twice weekly)+MTX (7.5 titrated to 20 mg/week) vs. MTX (7.5 titrated to 20 mg/week)Significantly higher area under curve of ACR-N for ETN+MTX than MTX (18.3%-years vs. 12.2%-years; P<0.0001) at 24 weeksFair
Etanercept+Sulfasalazine vs. Sulfasalazine
Combe et al., 200685
*Combe et al., 2009145
RCT
260
24 weeks
2 years
Active RA despite SSZ treatment; mean disease duration 6.6 yearsETN (25 mg twice weekly)+SSZ (2, 2.5, or 3 g/day) vs. SSZ (2, 2.5, or 3 g/day)Higher ACR 20 response rates between ETN+SSZ and SSZ (74% vs. 28%; P=NR)
Higher remission at 2 years ETN+SSZ than SSZ (DAS <2.5; 57% vs.4.0%; P<0.01)
Fair
Golimumab+MTX vs. MTX
*Emery et al., 200992 GO-BEFORERCT
637
24 weeks
MTX-naïve patient with active RAGOL (50 mg)+MTX vs. MTXHigher ACR 50 response rates between GOL+MTX and MTX (40.3% vs. 29.4%; P=0.042)Fair
Infliximab+MTX vs. MTX
St Clair et al., 2004;82 Smolen et al., 2006;83 *Smolen et al., 2009194
ASPIRE study
RCT
1,049
54 weeks
Early, aggressive RA; MTX-naive; mean disease duration 0.9 yearsINF (3 mg/kg/8 weeks)+MTX (20 mg/week) vs. INF (6 mg/kg/8 weeks)+MTX (20 mg/week) vs. MTX (20 mg/week)Significantly greater improvement of ACR-N for INF 3 mg+MTX and INF 6 mg+MTX than MTX (38.9% vs. 46.7% vs. 26.4%; P<0.001)
Higher remission in INF+MTX vs. MTX (DAS28-ESR<2.6; 21.3%, 12.3%; P<0.001)
Fair
*

New study added since last review.

In COMET, subjects were randomized to one of four treatment groups: (1) ETN+MTX for year 1 followed by the same treatment for year 2, (2) ETN+MTX for year 1 followed by ETN alone for year 2, (3) MTX for year 1 followed by ETN+MTX for year 2, or (4) MTX for year 1 followed by continued MTX for year 2. Thus, all subjects were treated with ETN+MTX or MTX for 1 year and we present the 52-week outcomes in this table

ADA = adalimumab; ETN = etanercept; mg = milligram; MTX = methotrexate; RA = rheumatoid arthritis; RCT = randomized controlled trial; 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.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.