n (%) | SAR200 + 26W taper | SAR150 + 26W taper | PBO + 52W taper | PBO + 26W taper |
---|---|---|---|---|
Primary endpoint and sensitivity analyses, n | 13 | 7 | 10 | 6 |
 Number of patients achieving SR at week 52 | 6 (46) | 3 (43) | 3 (30) | 0 |
 Number of patients achieving SR at week 52 excluding CRP | 6 (46) | 3 (43) | 6 (60) | 1 (17) |
 Number of patients achieving SR at week 52 excluding CRP and ESR | 6 (46) | 3 (43) | 6 (60) | 1 (17) |
Additional endpoint and sensitivity analyses, n | 27 | 14 | 28 | 14 |
 Number of patients achieving SR at week 24 | 13 (48) | 6 (43) | 11 (39) | 1 (7) |
 Number of patients achieving SR at week 24 excluding CRP | 13 (48) | 6 (43) | 16 (57) | 5 (36) |
 Number of patients achieving SR at week 24 excluding CRP and ESR | 13 (48) | 6 (43) | 16 (57) | 5 (36) |
Secondary endpoints | ||||
 Week 52, n | 13 | 7 | 10 | 6 |
  Achievement of disease remission no later than week 12a | 7 (54) | 4 (57) | 7 (70) | 3 (50) |
  Absence of disease flare from week 12 through week 52b | 7 (54) | 4 (57) | 7 (70) | 3 (50) |
  Sustained reduction of CRP from week 12 through week 52c | 8 (62) | 5 (71) | 6 (60) | 3 (50) |
  Successful adherence to the prednisone taper from week 12 through week 52d | 6 (46) | 3 (43) | 6 (60) | 2 (33) |
 Week 24, n | 27 | 14 | 28 | 14 |
  Achievement of disease remission no later than week 12a | 15 (56) | 9 (64) | 16 (57) | 6 (43) |
  Absence of disease flare from week 12 through week 24b | 15 (56) | 10 (71) | 21 (75) | 7 (50) |
  Sustained reduction of CRP from week 12 through week 24c | 17 (63) | 11 (79) | 20 (71) | 4 (29) |
  Successful adherence to the prednisone taper from week 12 through week 24d | 13 (48) | 7 (50) | 18 (64) | 5 (36) |