ライフサイエンスコーパス: belimumab

1 y may predict a better treatment response to belimumab.

2 52) and 76-week (BLISS-76) trials, comparing belimumab 1 mg/kg or 10 mg/kg versus placebo (plus stand

3 randomized to receive intravenous placebo or belimumab 1, 4, or 10 mg/kg, plus standard therapy, and

4 ntrolled study in 449 patients of 3 doses of belimumab (1, 4, 10 mg/kg) or placebo plus standard of c

5 ore >/=4 (n = 449) were randomly assigned to belimumab (1, 4, or 10 mg/kg) or placebo in a 52-week st

6 sk of severe flares in patients treated with belimumab 10 mg/kg (P</=0.01) who were anti-dsDNA positi

7 the long-term continuation study of monthly belimumab 10 mg/kg.

8 tients in the placebo group were switched to belimumab 10 mg/kg.

9 ndomized in a 1:1:1 ratio to receive 1 mg/kg belimumab, 10 mg/kg belimumab, or placebo intravenously

10 /kg belimumab (34%) (P = 0.023) and 10 mg/kg belimumab (23%) (P = 0.13).

11 ed SLE Flare Index) was reduced with 1 mg/kg belimumab (34%) (P = 0.023) and 10 mg/kg belimumab (23%)

12 SLE who were enrolled in a clinical trial of belimumab, a BLyS-specific inhibitor, plus standard of c

13 Belimumab, a human neutralizing anti-BLyS monoclonal ant

14 Although BAFF-depleting therapy with belimumab achieved approval for lupus, other BAFF inhibi

15 her SELENA-SLEDAI score thresholds, 10 mg/kg belimumab achieved better discrimination at weeks 52 and

16 Belimumab added to standard therapy was generally well-t

17 Although belimumab, an agent that inhibits B-cell survival, is th

18 as remission induction therapy, gusperimus, belimumab and complement factor C5a inhibition are also

19 fer, but thus far no definitive link between belimumab and congenital abnormalities.

20 d serious adverse events were similar in the belimumab and placebo groups.

21 ve focused on the optimization of the use of Belimumab and Rituximab using information generated prev

22 2.4%, 39.1%, and 38.5% with placebo, 1 mg/kg belimumab, and 10 mg/kg belimumab, respectively.

23 Belimumab appears to promote normalization of serologic

24 Belimumab at 10 mg/kg plus standard therapy met the prim

25 , diphtheria toxin-single chain Fv (DC2219), belimumab, atacicept, abatacept, and abetimus sodium.

26 This drug, belimumab (Benlysta), is a human monoclonal antibody tha

27 od in patients with SLE, which suggests that belimumab can be administered long term with an acceptab

28 The approval of belimumab combined a pioneering approach to genomics-bas

29 ponse rates were 57.6 and 43.2% for 10 mg/kg belimumab, compared with 43.6 and 33.8% for placebo in B

30 Belimumab did not substantially affect preexisting antip

31 Safety data through 4 years of belimumab exposure (1,165 cumulative patient-years) are

32 to AEs were stable or declined during 4-year belimumab exposure.

33 percentage of SLE patients do not respond to belimumab, further research is needed to better characte

34 During the extension period, patients in the belimumab group either received the same dose or were sw

35 res from baseline were 19.5% in the combined belimumab group versus 17.2% in the placebo group.

36 first SLE flare was 67 days in the combined belimumab group versus 83 days in the placebo group.

37 Recently, belimumab has been successful in two phase III trials.

38 Only belimumab has recently met its primary outcome in two ph

39 d data from 2 phase III trials, the Study of Belimumab in Subjects with SLE 52-week (BLISS-52) and 76

40 extension, and 296 continued treatment with belimumab in the long-term continuation study.

41 Belimumab is the first biologically approved therapy in

42 A BAFF inhibitor, belimumab, is the first new drug in 50 years to be appro

43 on and progression of RAIDs (i.e. rituximab, belimumab, mycophenolate and azathioprine).

44 he highlight of the year was the approval of belimumab on the basis of two major trials.

45 The effect of belimumab on the reduction of SLE disease activity or fl

46 ratio to receive 1 mg/kg belimumab, 10 mg/kg belimumab, or placebo intravenously on days 0, 14, and 2

47 Belimumab plus standard therapy significantly improved S

48 ith placebo, 1 mg/kg belimumab, and 10 mg/kg belimumab, respectively.

49 Treatment with belimumab resulted in a 63-71% reduction of naive, activ

50 Finally, the initial pregnancy data for belimumab suggest a high degree of transplacental transf

51 On the contrary, two large phase 3 trials of belimumab, the monoclonal antibody against B-lymphocyte

52 E patients responded significantly better to belimumab therapy plus SOC than to SOC alone.

53 rologically active patients, the addition of belimumab to SOC resulted in a response in 46% of patien

54 Belimumab-treated patients experienced significant decre

55 Belimumab-treated patients experienced significant susta

56 ng weeks 24-52 was significantly longer with belimumab treatment (154 versus 108 days; P = 0.0361).

57 uble-stranded DNA [anti-dsDNA] >/=30 IU/ml), belimumab treatment resulted in significantly better res

58 The rate with 1 mg/kg belimumab was 40.6% (P = 0.089).

59 Belimumab was biologically active and well tolerated.

60 lupus nephritis are being studied, including belimumab which was recently approved for nonrenal syste