Table 2.
Data from the 2-year LITHE study.
| Patient disposition (safety population) | N | Withdrawals %(n) | Completed %(n) | Rescue %(n) | Initiated OL TCZ8 at 52 weeks, % (n) | Completed 104 wks on initial therapy %(n) |
|---|---|---|---|---|---|---|
| Placebo + MTX | 392 | 27 (104) | 73 (288) | 50 (196) | 68 (266) | 5 (21) |
| TCZ4 + MTX | 399 | 22 (89) | 78 (310) | 24 (97) | 63 (253) | 9 (37) |
| TCZ8 + MTX | 399 | 22 (88) | 78 (311) | 15 (60) | 62 (248) | 12 (48) |
| Efficacy (ITT population) | Mean GmTSS from Bl [SD] (n) | No GmTSS progression %(n/m) | Adjusted mean AUC HAQ-DI from BL (n) | ACR70 % (n/n) | DAS28 remission %(n/n) | |
| Placebo + MTX | 393 | 1.96 [5.96] (294) | 66(195/294) | -139.4 (366) | 12 (48/393) | 53 (72/136) |
| TCZ4 + MTX | 399 | 0.58 [2.36] (343) | 75(256/343) | -287.5 (376) | 24 (97/399) | 55 (124/224) |
| TCZ8 + MTX | 398 | 0.37 [1.55] (353) | 83(292/353) | -320.8 (374) | 22 (89/398) | 65 (156/241) |
(n/n) patients with response/evaluable patients. If ACR70 could not be calculated because of missing data, patient was defined as nonresponder a that time point.
MTX, methotrexate; IR, inadequate responder; TCZ, tocilizumab; TCZ4, tocilizumab 4mg/kg; TCZ8, tocilizumab 8mg/kg; TNF, tumor necrosi: factor; DMARD, disease-modifying antirheumatic drug; ITT, intention to treat; OL, open-label; GmTSS, Genant-modified Total Sharp Score; AUC area under the curve; HAQ-DI, Health Assessment Questionnaire Disability Index; BL, baseline; ACR, American College of Rheumatology; DAS Disease Activity Index.