Table 1 Efficacy results at 12 weeks in patients with rheumatoid arthritis (RA)*
ResponsenEverolimus + MTXnPlacebo + MTXp Value
BaselineChange from baselineBaselineChange from baseline
ACR20, % (95% CI)6136.1 (24.2–49.0)6016.7 (8.3–27.6)0.022
ACR50, %618.2605.00.717
Response criteria
Tender joint count (maximum 58)5124.5–10.65724.5–5.00.003
Swollen joint count (maximum 60)5117.6–8.55716.9–3.20.002
Patient pain (VAS, mm)5253.9–17.65752.2–3.90.001
Patient global disease activity (VAS, mm)5254.6–15.45753.2–3.50.002
Physician global disease activity (VAS), mm)5153.9–18.65754.4–11.20.043
Physical function on HAQ (scale 1–3)501.4−0.28571.37−0.150.157
ESR, mm/h5234.610.55631.9−0.5<0.001
CRP, mg/litre5622.50−4.255816.722.340.153
  • *Values are the mean, except American College of Rheumatology 20% and 50% (ACR20 and ACR50, respectively) response rates, which are the percentage of patients meeting the improvement criteria (Binomial Blyth–Still–Casella 95% confidence intervals).

  • CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; MTX, methotrexate; VAS, visual analogue scale.