ライフサイエンスコーパス: belimumab

1 y may predict a better treatment response to belimumab.

2 lophosphamide, mycophenolate, rituximab, and belimumab.

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

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

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

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

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

8 ritis were randomized to receive intravenous belimumab 10 mg/kg or placebo with standard therapy (cyc

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

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

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

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

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

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

15 we have assessed the safety and efficacy of belimumab, a fully human IgG1 monoclonal antibody target

16 Belimumab, a human neutralizing anti-BLyS monoclonal ant

17 ly one new agent to treat patients with SLE: belimumab, a monoclonal antibody targeting B cell-activa

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

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

20 Belimumab added to standard therapy was generally well-t

21 Belimumab after rituximab significantly reduced serum Ig

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

23 Belimumab, an antibody against the B cell trophic factor

24 ponses sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor.

25 immune modulators: TNFSF13B/BAFF (target of belimumab, an approved therapeutic for SLE) and IL1RN (t

26 st a decade has passed since the approval of belimumab, an mAb directed against B lymphocyte stimulat

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

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

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

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

31 2.4%, 39.1%, and 38.5% with placebo, 1 mg/kg belimumab, and 10 mg/kg belimumab, respectively.

32 Belimumab appears to promote normalization of serologic

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

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

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

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

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

38 y levels were lower in patients treated with belimumab compared with placebo (geometric mean, 47 [95%

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

40 Belimumab did not increase incidence of serious adverse

41 Belimumab did not substantially affect preexisting antip

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

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

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

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

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

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

48 ere flares in the placebo group and 3 in the belimumab group.

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

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

51 FDA approval of belimumab in 2011 was the first successful SLE drug in n

52 Conversely, results using belimumab in patients with anti-neutrophil cytoplasmic a

53 esults were further promising for the use of belimumab in patients with rheumatoid arthritis and Sjog

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

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

56 We performed a post hoc analysis of the Belimumab International Study in Lupus Nephritis (BLISS-

57 Belimumab is both safe and effective for the treatment o

58 Belimumab is the first biologically approved therapy in

59 e B cell activating factor (BAFF) inhibitor, belimumab, is the first biologic drug approved for the t

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

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

62 lable for adults in the last decade, notably belimumab, obinutuzumab, and voclosporin.

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

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

65 ndomly assigned (1:1) to receive intravenous belimumab or placebo for 52 weeks.

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

67 Belimumab plus standard therapy significantly improved S

68 Belimumab reduced risk for severe flare compared with pl

69 Belimumab reduced the risk of a sustained 30% or 40% dec

70 Although well tolerated, the efficacy of belimumab remains limited and is not labeled for patient

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

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

73 Belimumab significantly reduced the risk of kidney-relat

74 Belimumab significantly suppressed B-cell repopulation c

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

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

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

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

79 Thus, our data suggest that the addition of belimumab to standard therapy could attenuate the risk o

80 Belimumab-treated patients experienced significant decre

81 Belimumab-treated patients experienced significant susta

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

83 with heterogeneity in clinical responses to belimumab treatment in humans.

84 rved improvement in the kidney response with belimumab treatment in patients with lupus nephritis and

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

86 ly, we found that anti-BAFF blockade through belimumab treatment was associated with poor vaccine imm

87 pproved by the Food and Drug Administration: belimumab, voclosporin (for lupus nephritis), and anifro

88 ne, mycophenolate mofetil, cyclophosphamide, belimumab, voclosporin, and anifrolumab.

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

90 Belimumab was biologically active and well tolerated.

91 Add-on belimumab was found to be most effective in improving th

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

93 open-label clinical trials, the approval of belimumab (which blocks B cell-activating factor (BAFF))