, hygiene, reach, grip, and activities
Number of tender joints (0-68) 33 19
-7.0
(-10.0, -4.1) 32 14.5
-9.6
(-12.6, -6.7) 33 25 31 21
-10.8
(-14.6, -7.1) 32 17
-15.1
(-18.8, -11.4) 30 30
Number of swollen joints (0-66) 20 10
-4.2
(-6.1, -2.3) 19.5 8
-6.2
(-8.1, -4.2) 21 15 19.5 13
-6.2
(-9.0, -3.5) 19 11
-7.2
(-9.9, -4.5) 19 18
Pain† 61 33
-11.0
(-17.0, -5.0) 60 30
-15.8
(-21.7, -9.9) 57 43 63.5 43
-12.4
(-22.1, -2.1) 65 33
-23.9
(-33.7, -14.1) 64 48
Patient global assessment† 66 34
-10.9
(-17.1, -4.8) 65 31
-14.9
(-20.9, -8.9) 64 45 70 46
-10.0
(-20.3, 0.3) 70 36
-17.4
(-27.8, -7.0) 71 51
Physician global assessment† 64 26
-5.6
(-10.5, -0.8) 64 23
-9.0
(-13.8, -4.2) 64 32 66.5 39
-10.5
(-18.6, -2.5) 66 28
-18.2
(-26.3, -10.0) 67.5 43
Disability index (HAQ)‡ 1.64 1.01
-0.18
(-0.34, -0.02) 1.55 0.96
-0.21
(-0.37, -0.05) 1.55 1.21 1.67 1.39
-0.25
(-0.42, -0.09) 1.75 1.34
-0.34
(-0.51, -0.17) 1.70 1.58
CRP (mg/dL) 2.79 1.17
-1.30
(-2.0, -0.59) 2.61 0.25
-2.156
(-2.86, -1.46) 2.36 1.89 3.11 1.77
-1.34
(-2.5, -0.15) 2.80 0.28
-2.52
(-3.72, -1.32) 3.705 3.06
The percent of ACR20 responders by visit for Study III is shown in Figure 1. Similar responses were observed in studies I, II, IV, and V.
*
The same patients may not have responded at each timepoint.
Figure 1 Percent of ACR20 Responders by Visit for Study III (Inadequate Response to MTX)*
16 HOW SUPPLIED/STORAGE AND HANDLING
ACTEMRA (tocilizumab) is supplied in single-use vials as a preservative-free, sterile concentrate (20 mg/mL) solution for intravenous infusion. The following packaging configurations are available:
Individually packaged, single-use vials:
NDC 50242-135-01 providing 80 mg/4 mL
NDC 50242-136-01 providing 200 mg/10 mL
NDC 50242-137-01 providing 400 mg/20 mL
Box of 4 single-use vials:
NDC 50242-135-04 providing 80 mg/4 mL
NDC 50242-136-04 providing 200 mg/10 mL
NDC 50242-137-04 providing 400 mg/20 mL
Storage and Stability: Do not use beyond expiration date on the container. ACTEMRA must be refrigerated at 2ºC to 8ºC (36°F to 46°F). Do not freeze. Protect the vials from light by storage in the original package until time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.
17 PATIENT COUNSELING INFORMATION
17.1 Patient Counseling
Patients should be advised of the potential benefits and risks of ACTEMRA. Physicians should instruct their patients to read the Medication Guide before starting ACTEMRA therapy.
Infections:
Inform patients that ACTEMRA may lower their resistance to infections. Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid eva luation and appropriate treatment.
Gastrointestinal Perforation:
Inform patients that some patients who have been treated with ACTEMRA have had serious side effects in the stomach and intestines. Instruct the patient of the importance of contacting their doctor immediately when symptoms of severe, persistent abdomina |
