eline of ≥ 0.3 units) at week 52 compared to 53% in the placebo treatment group.
Other Health-Related Outcomes
General health status was assessed by the Short Form Health Survey (SF-36) in Studies I – V. Patients receiving ACTEMRA demonstrated greater improvement from baseline compared to placebo in the Physical Component Summary (PCS), Mental Component Summary (MCS), and in all 8 domains of the SF-36.
14.2 Rheumatoid Arthritis–Subcutaneous Administration
The efficacy and safety of subcutaneously administered ACTEMRA was assessed in two double-blind, controlled, multicenter studies in patients with active RA. One study (SC-I) was a non-inferiority study that compared the efficacy and safety of ACTEMRA 162 mg administered every week subcutaneously (SC) to 8 mg per kg intravenously every four weeks. The second study (SC-II) was a placebo controlled superiority study that eva luated the safety and efficacy of ACTEMRA 162 mg administered every other week SC to placebo. Both SC-I and SC-II required patients to be >18 years of age with moderate to severe active rheumatoid arthritis diagnosed according to ACR criteria who had at least 4 tender and 4 swollen joints at baseline (SC-I) or at least 8 tender and 6 swollen joints at baseline (SC-II), and an inadequate response to their existing DMARD therapy, where approximately 20% also had a history of inadequate response to at least one TNF inhibitor. All patients in both SC studies received background non-biologic DMARD(s).
In SC-I, 1262 patients were randomized 1:1 to receive ACTEMRA SC 162 mg every week or ACTEMRA intravenous 8 mg/kg every four weeks in combination with DMARD(s). In SC-II, 656 patients were randomized 2:1 to ACTEMRA SC 162 mg every other week or placebo, in combination with DMARD(s). The primary endpoint in both studies was the proportion of patients who achieved an ACR20 response at Week 24.
The clinical response to 24 weeks of ACTEMRA SC therapy is shown in TABLE 7. In SC-I, the primary outcome measure was ACR20 at Week 24. The pre-specified non-inferiority margin was a treatment difference of 12%. The study demonstrated non-inferiority of ACTEMRA with respect to ACR20 at Week 24; ACR50, ACR70, and DAS28 responses are also shown in TABLE 7. In SC-II, a greater portion of patients treated with ACTEMRA 162 mg SC every other week achieved ACR20, ACR50, and ACR70 responses compared to placebo-treated patients (TABLE 7). Further, a greater proportion of patients treated with ACTEMRA 162 mg SC every other week achieved a low level of disease activity as measured by a DAS28-ESR less than 2.6 at Week 24 compared to those treated with placebo (TABLE 7).
Table 7 Clinical Response at Week 24 in Trials of Subcutaneous ACTEMRA (Percent of Patients)
SC-I* SC-II†
TCZ SC 162 mg every week
+ DMARD TCZ IV 8mg/kg
+ DMARD TCZ SC 162 mg every other week
+ DMARD Placebo
+ DMARD
N=558 N=537 N=437 N=219
TCZ = tocilizumab
* Per Protocol Population † Intent To Treat Population
ACR20
Week 24 69% 73.4% 61% 32%
Weighted difference (95% CI) -4% (-9.2, 1.2) 30% (22.0, 37.0)
ACR50
Week 24 47% 49% 40% 12%
Weighted difference (95% CI) -2% (-7.5, 4.0) 28% (21.5, 34.4)
ACR70
Week 24 24% 28% 20% 5%
Weighted difference (95% CI) -4% (-9.0, 1.3) 15% (9.8, 19.9)
Change in DAS28 [Adjusted mean]
Week 2 |
