Outcome (Time of Assessment) | No. Studies | No. Participants | Risk Ratio or Mean Differencea,b (95% CI) |
---|---|---|---|
ACR20 (16–24 wks) | 4 | 2063 | 2.53 (1.88, 3.39) |
ACR70 (16–24 wks) | 4 | 2063 | 5.94 (2.83, 12.48) |
Good EULAR response (24 wks) | 1 | 409 | 12.94 (5.77, 29.01) |
DAS28 Score (16–24 wks) | 3 | 1728 | −2.00 (−2.10, −1.91) |
DAS low disease activity (16 wks) | 3 | 1680 | 8.62 (6.22, 11.94) |
HAQ scores (24 wks) | 3 | 1964 | −0.29 (−0.34, −0.23) |
SF-36 physical component summary (24 wks) | 2 | 1628 | 4.72 (4.01, 5.43) |
SF-36 mental component summary (24 wks) | 2 | 1628 | 3.44 (2.34, 4.54) |
FACIT fatigue score (24 wks) | 2 | 1628 | 4.46 (3.35, 5.56) |
Any adverse event (AE) | 4 | 2060 | 1.14 (1.07, 1.21) |
Patients with at least 1 serious AE (16–24 wks) | 3 | 1725 | 1.50 (0.99, 2.25) |
Decrease in neutrophil counts from normal to low (24 wks) | 1 | 1216 | 7.11 (4.41, 11.46) |
Increase of 30% in LDL:HDL ratio (24 wks)c | 1 | 1220 | 1.66 (1.24, 2.23) |
Increase of 30% in total:HDL cholesterol ratio (24 wks)c | 1 | 1220 | 1.72 (1.16, 2.57) |
Upper respiratory infections (24 wks) | 1 | 410 | 1.29 (0.65, 2.60) |
Infections (24 wks) | 3 | 1961 | 1.18 (1.04, 1.34) |
Serious infections and infestations (16–24 wks) | 4 | 2060 | 1.80 (0.98, 3.32) |
Any gastrointestinal disorder (24 wks) | 3 | 1961 | 1.42 (1.18, 1.71) |
Rash (24 wks) | 1 | 410 | 3.63 (1.03, 12.82) |
Withdrawals due to inefficacy (16–24 wks) | 4 | 2064 | 0.28 (0.19, 0.43) |
Death (24 wks) | 2 | 1551 | 0.52 (0.07, 3.65) |
↵a Risk ratio calculated using Mantel-Haenszel method for all categorical measures except HAQ scores, change in HAQ scores, and change in DAS scores (continuous outcomes), for which mean differences were calculated between golimumab and placebo groups.
↵b For rare events or when counts were zero, risk difference uses the Mantel-Haenszel method.
↵c 30% change in ratio was reported in the study, but no explanation was provided for the choice of the 30% value. DMARD: disease-modifying antirheumatic drug; ACR: American College of Rheumatology; EULAR: European League Against Rheumatism; DAS: Disease Activity Score; DAS28: 28-joint DAS; HAQ: Health Assessment Questionnaire; SF-36: Medical Outcomes Study Short-Form 36 questionnaire; FACIT: Functional Assessment of Chronic Illness Therapy; LDL: low-density lipoprotein cholesterol; HDL: high-density lipoprotein cholesterol.