Measures of efficacy on RA disease activity at weeks 6 and 12
| Week 6 | Week 12 | |||
|---|---|---|---|---|
| Tofacitinib/atorvastatin* (N=50) | Tofacitinib/placebo* (N=47) | Tofacitinib/atorvastatin (N=46) | Tofacitinib/placebo (N=46) | |
| ACR20, % | 76.0 | 76.6 | 82.6 | 65.2 |
| ACR50, % | 48.0 | 42.6 | 67.4 | 45.7 |
| ACR70, % | 20.0 | 19.1 | 34.8 | 30.4 |
| Change from enrolment in CRP, mean (SD) | −26.9 (31.4) | −18.9 (25.4) | −28.9 (35.4) | −18.9 (27.2) |
| Change from enrolment in DAS28-4(ESR), mean (SD) | −2.2 (1.33) | −2.2 (1.12) | −2.8 (1.46) | −2.6 (1.28) |
| Change from enrolment in HAQ-DI, mean (SD) | −0.66 (0.66) | −0.58 (0.58) | −0.81 (0.69) | −0.57 (0.62) |
| DAS28-4(ESR) <2.6, % | 16.0 | 4.3 | 21.7 | 17.4 |
*Patients received tofacitinib 10 mg bid for 6 weeks, after which patients were randomly assigned 1:1 to atorvastatin 10 mg once daily or matching placebo in addition to open-label tofacitinib 10 mg bid for a further 6 weeks.
ACR, American College of Rheumatology; ACR20/50/70, 20/50/70% improvement in tender or swollen joint counts as well as 20/50/70% improvement in three of the other five ACR components; bid, twice daily; CRP, C-reactive protein; DAS28, disease activity score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ-DI, health assessment questionnaire–disability index; RA, rheumatoid arthritis.