Table 2.
Patients reporting PRO improvement greater than or equal to MCID at weeks 4, 12, and 24
| RA-BUILD (csDMARD-IR) | RA-BEACON (bDMARD-IR) | |||||
|---|---|---|---|---|---|---|
| PBO (N = 228), n (%) | BARI 2-mg (N = 229), n (%) | NNT, (95% CI) | PBO (N = 176), n (%) | BARI 2-mg (N = 174), n (%) | NNT, (95% CI) | |
| Week 4 | ||||||
| Pain VAS | 118 (51.8) | 146 (63.8)** | 8.3 (4.8, 33.2) | 79 (44.9) | 85 (48.9) | 25.2 (N/A) |
| HAQ-DI | 120 (52.6) | 141 (61.6) | 11.2 (N/A) | 76 (43.2) | 102 (58.6)** | 6.5 (3.9, 19.6) |
| FACIT-Fatigue | 109 (47.8) | 129 (56.3) | 11.7 (N/A) | 86 (48.9) | 104 (59.8)* | 9.2 (4.7, 187.9) |
| SF-36 PCS | 73 (32.0) | 104 (45.4)** | 7.5 (4.5, 22.0) | 52 (29.5) | 81 (46.6)** | 5.9 (3.7, 14.3) |
| PtGA | 124 (54.4) | 150 (65.5)* | 9.0 (5.0, 45.7) | 76 (43.2) | 97 (55.7)* | 8.0 (4.4, 46.0) |
| Week 12 | ||||||
| Pain VAS | 120 (52.6) | 163 (71.2)*** | 5.4 (3.7, 10.2) | 69 (39.2) | 95 (54.6)** | 6.5 (3.9, 19.8) |
| HAQ-DI | 124 (54.4) | 158 (69.0)** | 6.8 (4.3, 17.3) | 75 (42.6) | 102 (58.6)** | 6.2 (3.8, 17.6) |
| FACIT-Fatigue | 134 (58.8) | 145 (63.3) | 22.0 (N/A) | 85 (48.3) | 111 (63.8)** | 6.5 (3.9, 19.1) |
| SF-36 PCS | 92 (40.4) | 130 (56.8)*** | 6.1 (3.9, 13.6) | 56 (31.8) | 86 (49.4)*** | 5.7 (3.6, 13.4) |
| PtGA | 124 (54.4) | 160 (69.9)*** | 6.5 (4.1, 14.9) | 67 (38.1) | 111 (63.8)*** | 3.9 (2.8, 6.4) |
| Week 24 | ||||||
| Pain VAS | 99 (43.4) | 148 (64.6)*** | 4.7 (3.3, 8.1) | 55 (31.3) | 80 (46.0)** | 6.8 (4.0, 21.5) |
| HAQ-DI | 95 (41.7) | 147 (64.2)*** | 4.4 (3.2, 7.3) | 52 (29.5) | 87 (50.0)*** | 4.9 (3.3, 9.6) |
| FACIT-Fatigue | 97 (42.5) | 135 (59.0)*** | 6.1 (3.9, 13.6) | 66 (37.5) | 87 (50.0)* | 8.0 (4.4, 45.7) |
| SF-36 PCS | 77 (33.8) | 127 (55.5)*** | 4.6 (3.3, 7.8) | 37 (21.0) | 68 (39.1)*** | 5.5 (3.6, 11.6) |
| PtGA | 100 (43.9) | 147 (64.2)*** | 4.9 (3.4, 8.8) | 56 (31.8) | 88 (50.6)*** | 5.3 (3.5, 11.6) |
Missing data were imputed by NRI
NNT = 1/(probability of achieving MCID with BARI 2-mg—probability of achieving MCID with PBO). When the difference in response rates was not statistically significant between treatments, the CI for NNT was not derived
p values were calculated for the difference in MCID response rates using the Newcombe–Wilson method without continuity correction. *p < 0.05; **p < 0.01; ***p < 0.001
BARI baricitinib, bDMARD biologic disease-modifying anti-rheumatic drug, CI confidence interval, csDMARD conventional synthetic disease-modifying anti-rheumatic drug, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, IR inadequate responder, MCID minimally clinically important difference, N/A not applicable, NNT number needed to treat, PBO placebo, RA rheumatoid arthritis, PtGA Patient’s Global Assessment of Disease Activity, SF-36 PCS Short Form-36 Physical Component Score