Table 3.
Other secondary end points
End point | Mavrilimumab* (N=42) | Placebo (N=28) | P value |
Time to elevated erythrocyte sedimentation rate by week 26,† median (95% CI) weeks‡ | 26.1 (16.1, NE) | 12.1 (8.1, 16.6) | 0.028§ |
Time to elevated C reactive protein level by week 26,¶ median (95% CI) weeks‡ | NE (8.1, NE) | 12.3 (3.3, 24.1) | 0.038§ |
Time to signs and symptoms of giant-cell arteritis or new or worsening vasculitis by imaging by week 26, median (95% CI) weeks‡ | NE (NE, NE) | 25.1 (15.1, NE) | 0.065§ |
Cumulative prednisone dose at week 26, mean (SD) mg | 2074 (708) | 2403 (1014) | 0.067** |
Percentage of patients completing glucocorticoid taper†† and with normal erythrocyte sedimentation rate by week 26 | 19 (45.2%) | 4 (14.3%) | 0.020** |
Percentage of patients completing glucocorticoid taper†† and with normal C reactive protein level by week 26 | 10 (23.8%) | 4 (14.3%) | 0.55** |
Percentage of patients completing glucocorticoid taper†† and with no signs or symptoms of giant-cell arteritis by week 26 | 30 (71.4%) | 9 (32.1%) | 0.0031** |
Cumulative prednisone dose at week 38‡‡, mean (SD) mg | 2465 (1107) | 2845 (1320) | 0.16** |
Data are n (%) except as indicated.
*150 mg subcutaneously every 2 weeks.
†Elevated erythrocyte sedimentation rate is defined as the first rate greater than or equal to 30 mm/hour; patients with an elevated rate within 3 days of the first dose of study drug were excluded from the analysis.
‡Kaplan-Meier method.
§Log-rank test stratified by randomisation strata.
¶Elevated C reactive protein level is defined as the first level greater than or equal to 1.0 mg/dL; patients with an elevated level within 3 days of the first dose were excluded from the analysis.
**Analysed by Cochran-Mantel-Haenszel test stratified by randomisation strata. Nominal p value.
††Patients were considered to have completed glucocorticoid taper if by week 26 they were receiving 1 mg/day for patients who had a starting dose of 60 mg/day, or 0 mg/day for patients who had a starting dose of less than 60 mg/day.
‡‡After the 26-week treatment period, investigators could manage disease in patients at their discretion, including use of glucocorticoids.