ith placebo.
Table 3 Study CD2 - Clinical Response and Clinical Remission % Response or Remission (95% CI)
CIMZIA 400 mg ×3 + Placebo
N = 210 CIMZIA
400 mg
N = 215
*
Clinical response is defined as decrease in CDAI of at least 100 points, and clinical remission is defined as CDAI ≤ 150 points
†
p < 0.05
Week 26
Clinical Response* 36% (30%, 43%) 63% (56%, 69%)†
Clinical Remission* 29% (22%, 35%) 48% (41%, 55%)†
Baseline use of immunosuppressants or corticosteroids had no impact on the clinical response to CIMZIA.
14.2 Rheumatoid Arthritis
The efficacy and safety of CIMZIA were assessed in four randomized, placebo-controlled, double-blind studies (RA-I, RA-II, RA-III, and RA-IV ) in patients ≥ 18 years of age with moderately to severely active rheumatoid arthritis diagnosed according to the American College of Rheumatology (ACR) criteria. Patients had ≥ 9 swollen and tender joints and had active RA for at least 6 months prior to baseline. CIMZIA was administered subcutaneously in combination with MTX at stable doses of at least 10 mg weekly in Studies RA-I, RA-II, and RA-III. CIMZIA was administered as monotherapy in Study RA-IV.
Study RA-I and Study RA-II eva luated patients who had received MTX for at least 6 months prior to study medication, but had an incomplete response to MTX alone. Patients were treated with a loading dose of 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either 200 mg or 400 mg of CIMZIA or placebo every other week, in combination with MTX for 52 weeks in Study RA-I and for 24 weeks in Study RA-II. Patients were eva luated for signs and symptoms and structural damage using the ACR20 response at Week 24 (RA-I and RA-II) and modified Total Sharp Score (mTSS) at Week 52 (RA-I). The open-label extension follow-up study enrolled 846 patients who received 400 mg of CIMZIA every other week.
Study RA-III eva luated 247 patients who had active disease despite receiving MTX for at least 6 months prior to study enrollment. Patients received 400 mg of CIMZIA every four weeks for 24 weeks without a prior loading dose. Patients were eva luated for signs and symptoms of RA using the ACR20 at Week 24.
Study RA-IV (monotherapy) eva luated 220 patients who had failed at least one DMARD use prior to receiving CIMZIA. Patients were treated with CIMZIA 400 mg or placebo every 4 weeks for 24 weeks. Patients were eva luated for signs and symptoms of active RA using the ACR20 at Week 24.
Clinical Response
The percent of CIMZIA-treated patients achieving ACR20, 50, and 70 responses in Studies RA-I and RA-IV are shown in Table 4. CIMZIA-treated patients had higher ACR20, 50 and 70 response rates at 6 months compared to placebo-treated patients. The results in study RA-II (619 patients) were similar to the results in RA-I at Week 24. The results in study RA-III (247 patients) were similar to those seen in study RA-IV. Over the one-year Study RA-I, 13% of CIMZIA-treated patients achieved a major clinical response, defined as achieving an ACR70 response over a continuous 6-month period, compared to 1% of placebo-treated patients.
Table 4: ACR Responses in Studies RA-I, and RA-IV (Percent of Patients) Study RA-I
Methotrexate Combination
(24 and 52 weeks) Study RA-IV
Monotherapy
(24 weeks)
Response Placebo + MTX CIMZIA* 200 mg + MTX
q 2 weeks CIMZIA* 200 mg + MTX - Placebo + MTX Placebo CIMZIA† 400 mg
q 4 weeks CIMZIA† 400 mg - Placebo
N=199 N=393 (95% CI)&D |
