SUMMACTA was a 2-year, randomised, double-dummy, active-controlled, parallel-group, phase 3 multicentre trial with a double-blind period of 24 weeks «Burmester GR, Rubbert-Roth A, Cantagrel A ym. A ra...»1.
Patients (≥ 18 years of age) with RA (≥ 6 months, revised 1987 American College of Rheumatology (ACR) criteria) who met the following major criteria were included: swollen joint count of 4 or greater (66-joint count) and tender joint count of 4 or greater (68-joint count) at screening and baseline, C-reactive protein (CRP) 10 mg/L or greater and/or erythrocyte sedimentation rate (ESR) 28 mm/h or greater at screening.
Patients (n = 1262) were randomly assigned to receive tocilizumab-SC 162 mg weekly + lumeIV every 4 weeks or tocilizumab-IV 8 mg/kg every 4 weeks + lumeSC weekly in combination with traditional DMARD.
Primary endpoint
The proportion of tocilizumab-SC patients achieving an ACR20 response at week 24 was 69.4 % (95 % CI 65.5–73.2); for tocilizumab-IV patients, it was 73.4 % (95 % CI 69.6–77.1).
Secondary endpoint
ACR20, ACR50 and ACR70 response rates over 24 weeks were similar between groups. The weighted differences in the proportion of ACR50 and ACR70 responders at week 24 were -1.8 % (95 % CI -7.5–4.0) and -3.8 % (95 % CI -9.0–1.3), respectively.
The safety profile was similar between groups (safety population), except for more injection-site reactions (ISR) in the tocilizumab-SC group, though no statitical analysis was presented in the original paper.
This study was funded by Roche. F. Hoffmann-La Roche, Ltd
The study «Ogata A, Tanimura K, Sugimoto T ym. Phase III stud...»2had a double-blind, parallel-group, double-dummy, comparative phase III design. Patients were randomized to receive TCZ-SC 162 mg every 2 weeks or TCZ-IV 8 mg/kg every 4 weeks; no DMARDs were allowed during the study.
Eligible patients were ages 20–75 years and had RA for ≥6 months, as diagnosed using the 1987 criteria of the American College of Rheumatology (ACR) for the classification of RA. Additional inclusion criteria were as follows: an inadequate response of ≥ 12 weeks to any synthetic DMARD (MTX, sulfasalazine, bucillamine, and leflunomide), biologic DMARD (infliximab, etanercept, and adalimumab), or immunosuppressant (e.g., tacrolimus); ≥ 8 tender joints (of 68 joints); ≥ 6 swollen joints (of 66 joints); and an erythrocyte sedimentation rate (ESR) ≥ 30 mm/hour or a C-reactive protein level ≥ 1.0 mg/dl. Exclusion criteria included active tuberculosis, a history of serious allergies, and active hepatitis B or C.
Primary endpoint
At week 24, ACR20 response was achieved in 79.2 % (95 % confidence interval 72.9–85.5) of the TCZ-SC group and in 88.5 % (95 % CI 83.4–93.5) of the TCZ-IV group; the weighted difference was -9.4 % (95 % CI -17.6 – -1.2), confirming the noninferiority of TCZ-SC to TCZ-IV.
Secondary endpoint
The ACR70 response rate in the TCZ-SC mono group was 37.1 % (95 % CI 29.6–44.6) and in the TCZ-IV mono group was 41.0 % (95 % CI 33.3–48.7). The weighed differences of ACR50 and ACR70 response were -4.3 % (95 % CI -14.7–6.0) and -3.8 % (95 % CI 14.5–6.8), respectively.
Over 24 weeks, AEs occurred in 89.0 % (154 of 173) and 90.8 % (157 of 173) of patients, serious AEs occurred in 7.5 % (13 of 173) and 5.8 % (10 of 173) of patients, adverse drug reactions occurred in 83.2 % (144 of 173) and 86.1 % (149 of 173) of patients, and serious adverse drug reactions occurred in 3.5 % (6 of 173) and 5.8 % (10 of 173) of patients in the TCZ-SC monotherapy and TCZ-IV monotherapy groups, respectively. No deaths or malignancies were reported. Injection site reactions occurred in 12.1 % of patients (21 of 173) in the TCZ-SC monotherapy group and in 5.2 % of patients (9 of 173) in the TCZ-IV monotherapy group (placebo injection).
This study was funded by Chugai Pharmaceutical Co., Ltd. (Chugai).
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