ent of patients with reduction in SELENA-SLEDAI ≥4
36%
43%
47%
46%
53%
58%
Percent of patients with no worsening by BILAG index
65%
75%
69%
73%
79%
81%
Percent of patients with no worsening by PGA
63%
73%
69%
69%
79%
80%
Patients dropping out of the study early or experiencing certain increases in background medication were considered as failures in these analyses. In both studies, a higher proportion of placebo patients were considered as failures for this reason as compared to the BENLYSTA groups.
The 1 mg/kg dose is not recommended.
The reduction in disease activity seen in the SRI was related primarily to improvement in the most commonly involved organ systems namely, mucocutaneous, musculoskeletal, and immunology.
Effect in Black/African-American Patients:
Exploratory sub-group analyses of SRI response rate in patients of black race were performed. In Trial 2 and Trial 3 combined, the SRI response rate in black patients (N=148) in the BENLYSTA groups was less than that in the placebo group (22/50 or 44% for placebo, 15/48 or 31% for BENLYSTA 1 mg/kg, and 18/50 or 36% for BENLYSTA 10 mg/kg). In Trial 1, black patients (N = 106) in the BENLYSTA groups did not appear to have a different response than the rest of the study population. Although no definitive conclusions can be drawn from these subgroup analyses, caution should be used when considering BENLYSTA treatment in black/African-American SLE patients.
Effect on Concomitant Steroid Treatment:
In Trial 2 and Trial 3, 46% and 69% of patients, respectively, were receiving prednisone at doses > 7.5 mg/day at baseline. The proportion of patients able to reduce their average prednisone dose by at least 25% to ≤ 7.5 mg/day during Weeks 40 through 52 was not consistently significantly different for BENLYSTA relative to placebo in both trials. In Trial 2, 17% of patients receiving BENLYSTA 10 mg/kg and 19% of patients receiving BENLYSTA 1 mg/kg achieved this level of steroid reduction compared with 13% of patients receiving placebo. In Trial 3, 19%, 21%, and 12% of patients receiving BENLYSTA 10 mg/kg, BENLYSTA 1 mg/kg, and placebo, respectively, achieved this level of steroid reduction.
Effect on Severe SLE Flares:
The probability of experiencing a severe SLE flare, as defined by a modification of the SELENA Trial flare criteria which excluded severe flares triggered only by an increase of the SELENA-SLEDAI score to >12, was calculated for both Trials 2 and 3. The proportion of patients having at least 1 severe flare over 52 weeks was not consistently significantly different for BENLYSTA relative to placebo in both trials. In Trial 2, 18% of patients receiving BENLYSTA 10 mg/kg and 16% of patients receiving BENLYSTA 1 mg/kg had a severe flare compared with 24% of patients receiving placebo. In Trial 3, 14%, 18%, and 23% of patients receiving BENLYSTA 10 mg/kg, BENLYSTA 1 mg/kg and placebo, respectively, had a severe flare.
16 HOW SUPPLIED/STORAGE AND HANDLINGBENLYSTA is a sterile, preservative-free lyophilized powder for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a latex-free rubber stopper and a flip-off seal. Each 5-mL vial contains 120 mg of belimumab. Each 20-mL vial contains 400 mg of belimumab.
BENLYSTA is supplied as follows:
120 mg bel |
