Table IV.
Study | Length of study | Summary of treatment | Injection-site reactionsa | Serious infectionsa | Malignanciesa |
---|---|---|---|---|---|
Anti-TNFs: | |||||
Weinblatt et al. (2003); ARMADA39 | 24 wks | ADA 20, 40, or 80 mg, or pbo, Q2wks | 15.3 (all ADA gps combined) ADA 80 mg: 11.0 (P≤0.05 vs pbo) |
1.0 (all ADA gps combined) | 0.5 (all ADA gps combined) |
Keystone et al. (2004)44 | 52 wks | ADA 20 mg Q1wk, or 40 mg Q2wks, or pbo, + MTX | 24.1 | 3.8 (P≤0.02 vs pbo) | 0.1 |
Van de Putte et al. (2004)45 | 26 wks | ADA 20 or 40 mg Q2wks or Q1wk, or pbo | 10.6 (P≤0.05 vs pbo) | 2.3 (NS vs pbo) | 0.9 (NS vs pbo) |
Breedveld et al. (2006); PREMIER47 | 2 yrs | ADA 40 mg Q2wks, ADA 40mg Q2wks + MTX, or MTX | NR | ADA: 0.7b MTX: 1.6b ADA+MTX: 2.9b (P<0.05 vs ADA) |
ADA: 0.9b MTX: 0.9b ADA+MTX: 0.4b |
Maini et al. (1999);42 ATTRACT | 30 wks | IFX 3mg/kg or 10 mg/kg Q4wks or Q8wks, or pbo, + MTX | IFX + MTX: 16–20c Pbo + MTX:10c |
4.1 (all IFX + MTX gps combined; NS vs pbo) | 0.9 (all IFX + MTX gps combined; however, all 3 cases in IFX 10 mg/kg Q4wks gp) |
St Clair et al. (2004)48 | 54 wks | IFX 3 or 6 mg/kg, or pbo (at 0, 2, and 6 wks, then Q8wks), + MTX | IFX 3 mg/kg: 21c IFX 6 mg/kg: 15c Pbo: 7c |
IFX 3 mg/kg: 5.6 (P=0.02 vs pbo) IFX 6 mg/kg: 5.0 (P=0.04 vs pbo) |
1.1 (4 pts in IFX 6 mg/kg) |
Schiff et al. (2008); ATTEST61 | 1 yr | IFX 3 mg/kg Q8wks, or ABA ~10 mg/kg Q4wks, or pbo Q4wks, + MTX | NA (IV) | IFX: 8.5 ABA: 1.9 |
IFX: 1.2 ABA: 0.6 |
Moreland et al. (1999)38 | 6 mos | ETN 10 or 25 mg bw, or pbo | ETN 10 mg: 43 (P<0.001 vs pbo) ETN 25 mg: 49 (P<0.001 vs pbo) |
NR | NR |
Bathon et al. (2000)50 | 12 mos | ETN 10 or 25 mg bw, or MTX Q1wk | ETN 10 mg: 30 (P<0.05 vs MTX) ETN 25 mg: 37 (P<0.001 vs MTX) |
<3 (in each gp) | ETN 10 mg: 1.0 ETN 25 mg: 1.4 |
Klareskog et al. (2004); TEMPO43 | 52 wks | ETN 25 mg bw, MTX alone, or ETN 25 mg bw + MTX | ETN: 21 (P<0.0001 vs MTX) ETN + MTX: 10 (P=0.0002 vs MTX) MTX: 2 |
4 (for each gp) | ETN: 1.8 ETN + MTX: 0.4 MTX: 0.4 |
Weinblatt et al. (2007)51 | 1 yr | ETN 25 mg bw + ABA 2mg/kg Q4wks, or ETN 25 mg bw + pbo | NR | ETN + ABA: 3.5 ETN + pbo: 0.0 |
NR |
Emery et al. (2008); COMET49 | 52 wks | ETN 50 mg Q1wk, or pbo, + MTX | NR | ETN + MTX: 1.8 MTX: 3.0 |
ETN+MTX: 1 MTX: 1 |
Fleischmann et al. (2008); FAST4WARD57 | 24 wks | CTZ 400 mg, or pbo, Q4wks | CTZ: 4.5 Pbo: 13.8 |
CTZ: 1.8 Pbo: 0 |
CTZ: 0 Pbo: 0 |
Keystone et al. (2008);55 RAPID-1 | 52 wks | CTZ 200 or 400 mg Q2wks, or pbo, + MTX | CTZ 200 mg + MTX: 2.3 CTZ 400 mg + MTX: 0.8 Pbo + MTX: 0 |
CTZ 200 mg + MTX: 5.3b CTZ 400 mg + MTX: 7.3b Pbo + MTX: 2.2b |
CTZ 200 mg + MTX: 1.8 CTZ 400 mg + MTX: 1.0 Pbo + MTX: 0.5 |
Smolen et al. (2008); RAPID-256 | 24 wks | CTZ 200 or 400 mg Q2wks, or pbo, + MTX | CTZ 200 mg + MTX: 1.2 CTZ 400 mg + MTX: 2.0 |
CTZ 200 mg + MTX: 3.2 CTZ 400 mg + MTX: 2.4 Pbo + MTX: 0.8 |
CTZ 200 mg + MTX: 0.4 CTZ 400 mg + MTX: 0.4 Pbo + MTX: 0.8 |
Keystone et al. (2009); GO-FORWARD60 | 52 wks (24-wk data presented) | GOL 100 mg Q4wks; GOL 50 or 100 mg Q4wks + MTX; or pbo + MTX | GOL 50 mg + MTX: 2.4 GOL 100 mg + MTX: 4.8 GOL 100 mg: 7.5 Pbo + MTX: 3.0 |
GOL 50 mg + MTX: 0.9 GOL 100 mg + MTX: 4.8 GOL 100 mg: 3.0 Pbo + MTX: 0.7 |
GOL 50 mg + MTX: 0.0 GOL 100 mg + MTX: 1.0 GOL 100 mg: 1.5 Pbo + MTX: 0.7 |
Smolen et al. (2009); GO-AFTER59 | 24 wks | GOL 50 or 100mg, or pbo, Q4wks | GOL 50 mg: 4.0 GOL 100 mg: 11.0 Pbo: 3.0 |
GOL 50 mg: 2.0 GOL 100 mg: 1.0 Pbo: 2.0 |
GOL 50 mg: 1.0 GOL 100 mg: 1.0 Pbo: 0.0 |
IL-1 inhibitor: | |||||
Bresnihan et al. (1998)54 | 24 wks | ANA 30, 75, or 150 mg od, or pbo | ANA 30 mg: 50 ANA 75 mg: 73 ANA 150 mg: 81 Pbo: 25 |
ANA 75 mg: 0.9 ANA 150 mg: 3.4 Pbo: 0.8 |
NR |
Cohen et al. (2002)53 | 24 wks | ANA 0.04–2 mg/kg od (2 mg/kg data shown), or pbo | ANA 2 mg/kg: 63 Pbo: 28 |
ANA 2 mg/kg: 0.0 Pbo: 0.0 |
ANA 2 mg/kg: 1.4 Pbo: 1.4 |
T-cell co-stimulation inhibitor: | |||||
Genovese et al. (2005)37 | 6 mos | ABA ~10mg/kg, or pbo, + DMARDs | ABA: 5.0c Pbo: 3.0c |
2.3 (in each gp) | NR |
B-cell CD20 antigen: | |||||
Cohen et al. (2006); REFLEX36 | 24 wks | RTX (2 × 1000 mg), or pbo, + MTX | RTX: 23c,d Pbo: 18c,d |
RTX + MTX: 1.4 Pbo + MTX: 2.3 |
NR |
Data shown as percent of pts unless stated otherwise. Statistical significance is shown where available.
Number of events per 100 pt-yrs.
% pts with infusion reactions.
Occurring within 24 hours of first infusion.
ABA = abatacept; ADA = adalimumab; ANA = anakinra; bw = twice weekly; CTZ = certolizumab pegol; DMARD = disease-modifying antirheumatic drug; ETN = etanercept; GOL = golimumab; gp = group; IFX = infliximab; mos = months; MTX = methotrexate; NA = not applicable; NR = not reported; NS = not significant; od = once daily; pbo = placebo; pts = patients; Q1wk = every week; Q2wks = every 2 weeks; r = randomized; RTX = rituximab; wks = weeks; yrs = years.