ライフサイエンスコーパス: daclizumab

1 re than nondepleting agents (basiliximab and daclizumab).

2 of the radiolabeled anti-CD25 antibody (90)Y-daclizumab.

3 bition in vivo, although it was required for daclizumab.

4 B received Alemtuzumab, and group C received Daclizumab.

5 IT-T15 cells or rat islets after exposure to daclizumab.

6 ither a prick nor an intradermal response to daclizumab.

7 sion consisted of sirolimus, tacrolimus, and daclizumab.

8 was no correlative decrease associated with daclizumab.

9 adverse effects in the patients treated with daclizumab.

10 tions and no serious side effects related to daclizumab.

11 ith advanced or steroid-refractory GVHD with daclizumab.

12 rferon beta and high-dose daclizumab group), daclizumab 1 mg/kg every 4 weeks (interferon beta and lo

13 Daclizumab 1 mg/kg given immediately after pediatric liv

14 The treatment arm (n=61) received daclizumab 1 mg/kg immediately after liver transplantati

15 econd cohort of 19 patients was treated with daclizumab 1 mg/kg on days 1, 4, 8, 15, and 22.

16 first cohort of 24 patients was treated with daclizumab 1 mg/kg on days 1, 8, 15, 22, and 29.

17 ily equivalent was given in conjunction with daclizumab 1 mg/kg or placebo on study days 1, 4, 8, and

18 patients were randomized into three groups: daclizumab 1 mg/kg per dose every 14 days for five doses

19 02/00 (n=29) received induction with either daclizumab (1 mg/kg on day 0, 7, 14), OKT 3 (5 mg/day x0

20 We administered daclizumab (1.0 mg per kilogram of body weight) or place

21 ion to receive either induction therapy with daclizumab (1.0 mg per kilogram of body weight), given i

22 Daclizumab, 1 mg/kg of body weight, every 2 weeks for a

23 ded into two groups according to the dose of daclizumab: 1 mg/kg on day 0 and every 14 days for five

24 era, 1994 to 2002, when basiliximab (1998), daclizumab (1998), and rabbit antithymocyte globulin (rA

25 omly assigned to receive add-on subcutaneous daclizumab 2 mg/kg every 2 weeks (interferon beta and hi

26 ery 14 days for five doses (group I, n=107), daclizumab 2 mg/kg per dose every 14 days for two doses

27 Moreover, the two-dose regimen of daclizumab (2 mg/kg on days 0 and 14) compares favorably

28 steroids, and 15 patients (group B) received daclizumab, 2 mg/kg on POD 0 and 14, with tacrolimus, my

29 Of the 126 patients given daclizumab, 28 (22 percent) had biopsy-confirmed episode

30 ng hospitalization appeared to be lower with daclizumab (7.3 vs. 16%, P<0.0036) with a similar trend

31 he first 6 months when compared with OKT3 or daclizumab (7.7 vs. 60 vs. 50%).

32 in the group receiving corticosteroids plus daclizumab (77% vs 94%; P =.02).

33 val was excellent in both placebo- (91%) and daclizumab- (93%) treated patients.

34 ell subset, which is selectively expanded by daclizumab, a CD25-blocking Ab that suppresses multiple

35 Daclizumab, a highly humanized, specific interleukin-2 r

36 Daclizumab, a humanised monoclonal antibody, reduced mul

37 Administration of daclizumab, a humanized mAb directed against the IL-2Ral

38 In search of the mechanisms by which daclizumab, a humanized monoclonal antibody against CD25

39 Daclizumab, a humanized monoclonal antibody against the

40 Therefore, we investigated the effects of daclizumab, a humanized monoclonal antibody directed aga

41 We examined whether treatment with daclizumab, a humanized monoclonal antibody specific for

42 The immunosuppression regimen consisted of daclizumab, a humanized monoclonal antibody that binds t

43 Daclizumab, a humanized monoclonal IgG1 directed against

44 T-cell-directed therapies (thymoglobulin and daclizumab, all patients), alone or with the addition of

45 After cessation of daclizumab, allograft rejection increased to levels seen

46 i (0.444 MBq) of (211)At-7G7/B6 (P < .05) or daclizumab alone (P < .05).

47 , compared with those in the depsipeptide or daclizumab alone groups (P < .001).

48 ement was not statistically significant with daclizumab (alone or with steroids), basiliximab alone,

49 Prophylaxis with daclizumab also delayed the onset of the first biopsy-pr

50 study, 28 were randomly assigned to receive daclizumab and 27 served as the control group.

51 Daclizumab and 7G7/B6 are directed toward different epit

52 er of reports of anti-interleukin therapies, daclizumab and anakinra, have supported a role for these

53 Daclizumab and antithymocyte globulin (ATG) have been sh

54 Both daclizumab and ATG therapy resulted in a significant red

55 mmunosuppression consisted of induction with daclizumab and maintenance therapy with tacrolimus and s

56 tocol transplant biopsies (n=246), and serum daclizumab and mycophenolic acid (MPA) trough levels wer

57 There were no adverse reactions to daclizumab and no significant differences between the gr

58 Daclizumab and ocrelizumab are monoclonal antibodies tha

59 Forty subjects received daclizumab and their clinical outcomes were compared aga

60 CW (tacrolimus, mycophenolate mofetil (MMF), daclizumab, and corticosteroids until day 4) with tacrol

61 ual induction therapy with thymoglobulin and daclizumab, and low-dose maintenance tacrolimus and cort

62 adjunct use of the interleukin-2 antagonist daclizumab, and most recently allograft irradiation may

63 New monoclonal antibodies such as daclizumab, and tumor necrosis factor alpha inhibitors s

64 tem facilitated the development of effective daclizumab antibody therapy for select patients with leu

65 Daclizumab appears safe; its efficacy in this pilot prot

66 Basiliximab and daclizumab are potent and relatively safe immunosuppress

67 7.6% in the alemtuzumab arm and 95.1% in the daclizumab arm at 1 year (95% confidence interval of dif

68 d 89.9% compared with 82.3% and 82.3% in the daclizumab arm.

69 pectively evaluated 27 patients who received daclizumab as induction immunosuppression and compared t

70 Thirty-two patients were given daclizumab as induction therapy in the setting of hepati

71 -T-cell depleting antibody to the CD25 cell, daclizumab, as a single-dose induction agent immediately

72 munosuppressive regimen with the addition of daclizumab at 1 mg/kg for five doses over 10 weeks in th

73 activity to their respective marketed drugs daclizumab, bevacizumab, and infliximab.

74 However, daclizumab can be used safely in patients with preexisti

75 Daclizumab can decrease the incidence of acute rejection

76 afety and efficacy of two dosing regimens of daclizumab compared with no antibody induction in SKPT r

77 rolimus, and the anti-IL-2 receptor antibody daclizumab consistently resulted in formation of inhibit

78 Collectively, our results indicate that daclizumab could inhibit CD25(+) effector T-cell functio

79 on therapy with antithymocyte globulin (ATG)/daclizumab (Dac) (each with fewer doses than if used alo

80 Daclizumab (Dac), an Ab against the IL-2R alpha-chain, i

81 Given the recent withdrawal of daclizumab (DAC), the safety and efficacy of thymoglobul

82 ICG was conjugated to the antibodies daclizumab (Dac), trastuzumab (Tra), or panitumumab (Pan

83 The patients given daclizumab did not have any adverse reactions to the dru

84 he proliferation of karpas299 cells, whereas daclizumab did not inhibit cell proliferation.

85 s then stratified according to the number of daclizumab doses: 4-5 doses (n=45) or 1-3 doses (n=26).

86 d, double-blind, placebo-controlled study of daclizumab (DZB) and mycophenolate mofetil (MMF) includi

87 addition of humanized IL-2 receptor antibody daclizumab (DZB) to CsA-based immunosuppression decrease

88 Daclizumab effectively reduced the incidence and delayed

89 Combination of depsipeptide with daclizumab enhanced the antitumor effect, as shown by bo

90 ion; in this group 0 of 13 (0%) treated with daclizumab experienced at least one high-grade rejection

91 Daclizumab first-dose doubling and extended use for 6 mo

92 volved the use of sirolimus, tacrolimus, and daclizumab for immunosuppression.

93 d; and era 4, 1998 to 2000 (n = 275), use of daclizumab for induction immunosuppression, primarily en

94 zed study of corticosteroids with or without daclizumab for initial treatment of acute GVHD was condu

95 ntravenously or receptor-saturating doses of daclizumab given at 100 microg weekly for 4 weeks intrav

96 at 0.5 mg/kg every other day for 2 weeks, or daclizumab, given at 100 microg weekly for 4 weeks, inhi

97 t), as compared with 5 of 28 patients in the daclizumab group (18 percent; relative risk, 2.8; 95 per

98 and 3.58 in the interferon beta and low-dose daclizumab group (25%, -76% to 68%; p=0.51).

99 compared with 77 of the 216 patients in the daclizumab group (47.7 percent vs. 35.6 percent, P=0.007

100 th 1.32 in the interferon beta and high-dose daclizumab group (difference 72%, 95% CI 34% to 88%; p=0

101 te rejection compared with four (18%) in the daclizumab group (P<0.04).

102 e control group, as compared with two in the daclizumab group (P= 0.03), and the time to a first epis

103 he control group and 0.19 per patient in the daclizumab group (P=0.02).

104 of rejection was significantly longer in the daclizumab group (P=0.04).

105 ejection rates (<6 months) were lower in the daclizumab group as compared with the OKT3 group, i.e.,

106 point was almost three times as long in the daclizumab group as in the placebo group during the firs

107 group p=0.002; interferon beta and high-dose daclizumab group p<0.0001).

108 placebo group (interferon beta and low-dose daclizumab group p=0.002; interferon beta and high-dose

109 The daclizumab group received 2 mg/kg intravenously before o

110 The rate of rejection was lower in the daclizumab group than in the placebo group (41.3 percent

111 More patients in the daclizumab group than in the placebo group died of infec

112 in the control group and 22 patients in the daclizumab group were available for analysis at 6 months

113 every 2 weeks (interferon beta and high-dose daclizumab group), daclizumab 1 mg/kg every 4 weeks (int

114 every 4 weeks (interferon beta and low-dose daclizumab group), or interferon beta and placebo for 24

115 from 44% in the placebo group to 28% in the daclizumab group.

116 in the placebo group to 73+/-70 days in the daclizumab group.

117 3) versus alemtuzumab (group B, N=43) versus daclizumab (group C, N=42), using exactly the same three

118 ells was seven to eight times higher in both daclizumab groups than in the interferon beta and placeb

119 al rate in those with DGF in the placebo and daclizumab groups were 93% and 98%, respectively.

120 tients who received mycophenolate mofetil or daclizumab had a less likelihood of achieving a BR.

121 Daclizumab had little toxicity.

122 Daclizumab had no effect on the radiographic or immediat

123 Induction therapy with daclizumab has been shown to be efficacious in the preve

124 Daclizumab has substantial activity for the treatment of

125 Humanized anti-CD25 antibodies (eg, daclizumab) have been successfully used to treat several

126 e the alpha chain of the IL-2 receptor (e.g. daclizumab) have been used to prevent allograft rejectio

127 atients with multiple sclerosis who received daclizumab high-yield process (HYP) for 52 weeks.

128 Daclizumab high-yield process (HYP) is a humanized monoc

129 f depsipeptide alone and in combination with daclizumab (humanized anti-Tac) in a murine model of hum

130 ogression confirmed at 12 weeks was 16% with daclizumab HYP and 20% with interferon beta-1a (P=0.16).

131 autoimmune hepatitis; a contributory role of daclizumab HYP could not be excluded.

132 :1) to receive 150 mg or 300 mg subcutaneous daclizumab HYP every 4 weeks for 52 weeks (treatment ini

133 These results support further assessment of daclizumab HYP for relapsing-remitting multiple sclerosi

134 were reported in 15% of the patients in the daclizumab HYP group and in 10% of those in the interfer

135 Infections were more common in the daclizumab HYP group than in the interferon beta-1a grou

136 the second year of continuous treatment with daclizumab HYP or during treatment washout and re-initia

137 with relapsing-remitting multiple sclerosis, daclizumab HYP showed efficacy superior to that of inter

138 The annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a (0.22 vs. 0.

139 RI) over a period of 96 weeks was lower with daclizumab HYP than with interferon beta-1a (4.3 vs. 9.4

140 s on liver-function testing were higher with daclizumab HYP than with interferon beta-1a.

141 nt initiation group); those who had received daclizumab HYP were randomly assigned (1:1) to continue

142 the washout and re-initiation group (300 mg daclizumab HYP) died because of autoimmune hepatitis; a

143 sing-remitting multiple sclerosis to compare daclizumab HYP, administered subcutaneously at a dose of

144 points were the safety and immunogenicity of daclizumab HYP.

145 nd immunogenicity of extended treatment with daclizumab HYP.

146 beta-1a (0.22 vs. 0.39; 45% lower rate with daclizumab HYP; P<0.001).

147 .3 vs. 9.4; 54% lower number of lesions with daclizumab HYP; P<0.001).

148 In the presence of daclizumab, IL-2 serum concentrations increased and IL-2

149 This nonrandomized study examined the use of daclizumab in 39 of the last 97 liver transplants perfor

150 Since March 1998, we studied the effect of daclizumab in a nonrandomized, prospective study of 233

151 transplants were included; 43 (50%) received daclizumab in addition to conventional immunosuppression

152 n a pilot study to determine the efficacy of daclizumab in conjunction with corticosteroids and mycop

153 We review our experience with the use of daclizumab in liver transplant recipients.

154 y in induction patients, but the efficacy of daclizumab in preventing rejection was independent of th

155 Treatment with daclizumab in the pooled analysis demonstrated a signifi

156 ith a humanized antibody preparation such as daclizumab in the presence of a negative skin test to th

157 humanized monoclonal antibody against CD25 (daclizumab) in 10 multiple sclerosis patients with incom

158 d on naive and memory cells and inhibited by daclizumab independently of cell division.

159 recipients receiving combined thymoglobulin/daclizumab induction along with reduced tacrolimus dosin

160 tocol modifications were introduced in 1998: daclizumab induction and frequent rejection surveillance

161 All patients received daclizumab induction and maintenance corticosteroids.

162 Each group received daclizumab induction and methylprednisolone maintenance.

163 es, under immunosuppression therapy based on daclizumab induction and tacrolimus/sirolimus maintenanc

164 ulticenter survey of initial experience with daclizumab induction in combination with TAC, MMF, and s

165 creas transplant (SKPT) recipients receiving daclizumab induction in combination with tacrolimus (TAC

166 al pretransplant (P=0.007) and not receiving daclizumab induction therapy (P=0.02) (24 such deaths).

167 s the largest published series to date using daclizumab induction therapy in a renal-sparing regimen.

168 Daclizumab induction therapy is as efficacious as OKT3 i

169 l dysfunction have less acute rejection with daclizumab induction therapy.

170 y comparing 209 adult liver transplants with daclizumab induction to 115 transplants with no inductio

171 -month results in 10 patients using extended daclizumab induction to safely eliminate steroid use in

172 In 1995, cyclophosphamide or daclizumab induction was added to the tacrolimus-steroid

173 I under Edmonton-like immunosuppression with daclizumab induction, either without interventions (SI-c

174 r EC-MPS along with a combined thymoglobulin/daclizumab induction, low tacrolimus dosing and steroid

175 , and combined rabbit antithymocyte globulin/daclizumab induction, previously showed at 1 year posttr

176 Extended daclizumab induction, tacrolimus, and mycophenolate mofe

177 ransplant renal dysfunction is possible with daclizumab induction.

178 In conclusion, repeated (90)Y-daclizumab infusions directed predominantly toward nonma

179 ardized schedule, while ultimately receiving Daclizumab infusions every 4 weeks.

180 Consistent with this are reports that daclizumab inhibits human CD25(+) effector cell cytokine

181 Daclizumab is a genetically engineered human IgG1 monocl

182 Daclizumab is a humanized mAb that binds the IL-2 recept

183 Daclizumab is a humanized monoclonal antibody against th

184 Daclizumab is a monoclonal antibody directed against the

185 hese data suggest that the truncated dose of daclizumab is as effective as the standard regimen for A

186 Daclizumab is safe and effective in reducing the inciden

187 egative skin test and safe administration of daclizumab is surprising because the similarity of these

188 d dosing schedule resulted in subtherapeutic daclizumab levels in liver transplant recipients.

189 Early daclizumab levels of more than 5 microg/mL were observed

190 Combination therapy with daclizumab may be an important adjunct in immunosuppress

191 ptor with the human IgG1 monoclonal antibody daclizumab may prevent rejection of allografts after car

192 In this study, we investigated the effect of daclizumab-mediated CD25 blockade on Treg homeostasis in

193 The remaining 25 patients received daclizumab, mycophenolate mofetil, and steroids, with th

194 Either OKT3 (n=26) or daclizumab (n=21) were used for induction therapy, with

195 ned to receive interferon beta and high-dose daclizumab (n=75), interferon beta and low-dose daclizum

196 lizumab (n=75), interferon beta and low-dose daclizumab (n=78), or interferon beta and placebo (n=77)

197 1, n = 29), group 3a (April 2001 to present, daclizumab, n = 51), and group 3b (April 2001 to present

198 these differences, as does a humanized form (daclizumab) now approved for the prevention of renal all

199 tly in late-phase clinical trials, including daclizumab, ocrelizumab, and ofatumumab.

200 ditional follow-up is needed to determine if daclizumab offers any long-term benefit in terms of redu

201 There was no beneficial effect of daclizumab on graft survival at 3 years, but the trial w

202 Effects of daclizumab on prespecified subsets of lymphocytes and qu

203 Daclizumab or ATG combined with a maintenance immunosupp

204 We assessed the safety and efficacy of daclizumab or ATG prophylaxis in combination with triple

205 to receive prophylactic therapy with either daclizumab or ATG.

206 Patients were randomized to receive either daclizumab or basiliximab versus RATG for induction in c

207 nduction therapy with alemtuzumab or IL-2RA (daclizumab or basiliximab) was used.

208 Protocols with daclizumab or etanercept during induction had higher rat

209 oids, and antibody induction therapy (either daclizumab or OKT3).

210 nd corticosteroids) to receive five doses of daclizumab or placebo.

211 h most patients receiving rATG, basiliximab, daclizumab, or alemtuzumab (2003).

212 iver) transplant (P = 0.002), induction with daclizumab (P = 0.005), patient at home prior to transpl

213 The recent approval of daclizumab prompted us to initiate this pilot study usin

214 The beneficial effect of daclizumab prophylaxis upon the incidence of acute rejec

215 We aimed to assess whether daclizumab reduces disease activity in patients with act

216 Daclizumab reduces the frequency of acute rejection in k

217 Treg declines were not associated with daclizumab-related clinical benefit or cutaneous adverse

218 Therapy with daclizumab resulted in a significant decrease in the inc

219 mphocytes, whereas other medications such as Daclizumab (Roche Laboratories, Nutley, NJ) block the in

220 Because of daclizumab's favorable toxicity profile and response rat

221 tokine production is also dependent on IL-2, daclizumab's inhibition of CD40L expression could be due

222 Induction therapy with daclizumab safely reduces the frequency and severity of

223 tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF gr

224 dose daclizumab (SB group) or extended dose daclizumab (SF group).

225 or anticipated use of cytolytic therapy with daclizumab should be avoided.

226 The combination of corticosteroids and daclizumab should not be used as initial therapy of acut

227 Treatment with daclizumab significantly prevented development of high-g

228 tandard cyclosporin-based immunosuppression, daclizumab significantly reduced the frequency of acute

229 th HCV were randomized to receive tacrolimus+daclizumab (steroid-free) vs. tacrolimus+corticosteroids

230 then tacrolimus+mycophenolate mofetil (MMF)+daclizumab (steroid-free) vs. tacrolimus+MMF+corticoster

231 ic efficacy by combining (211)At-7G7/B6 with daclizumab support a clinical trial of this regimen in p

232 utic efficacy by combining depsipeptide with daclizumab supports a clinical trial of this combination

233 To prevent rejection, primates were given daclizumab, tacrolimus, and rapamycin.

234 The combination of daclizumab, tacrolimus, mycophenolate mofetil, and stero

235 zed 2:1 to receive alemtuzumab/tacrolimus or daclizumab/tacrolimus/mycophenolate.

236 s in development include alemtuzumab, BG-12, daclizumab, teriflunomide, laquinimod, and B-cell-target

237 We report that daclizumab therapy caused an ~50% decrease in Tregs over

238 Instead, daclizumab therapy was associated with a gradual decline

239 immunoregulation of activated T cells during daclizumab therapy.

240 ctivity of humanized anti-IL-2 receptor mAb (Daclizumab) therapy in the treatment of patients with se

241 46 evaluable HL patients treated with (90)Y-daclizumab there were 14 complete responses and nine par

242 The addition of daclizumab to a tacrolimus-mycophenolate mofetil-based i

243 were 78% in the placebo group and 82% in the daclizumab treated group.

244 ograft; daclizumab treated, right allograft; daclizumab treated, left allograft.

245 l, right allograft; control, left allograft; daclizumab treated, right allograft; daclizumab treated,

246 ntation did not significantly differ between daclizumab-treated and control groups.

247 A trend toward improved survival in the daclizumab-treated group was noted.

248 acute rejection, whereas no patients in the daclizumab-treated group with DGF had graft loss due to

249 al function was similar between placebo- and daclizumab-treated groups in both the TT and DT trials.

250 iferative disorder (PTLD) in placebo- versus daclizumab-treated groups was comparable in both clinica

251 aily edema scores and curves for control and daclizumab-treated groups were compared.

252 b induction was slightly higher than that in daclizumab-treated patients (28.8+/-24.6% vs 21.3+/-21.3

253 In addition, 1 of 12 (9%) daclizumab-treated patients experienced one or more epis

254 significantly different between placebo and daclizumab-treated patients in the TT trial (83% vs. 84%

255 ival rates were similar between placebo- and daclizumab-treated patients with DGF.

256 survival at 12 months was 95 percent in the daclizumab-treated patients, as compared with 90 percent

257 pretransplantation GAD autoantibody-positive daclizumab-treated recipients compared with GAD autoanti

258 having at least one event compared to 33% of daclizumab-treated subjects (P=0.04).

259 Here we show that daclizumab treatment leads to only a mild functional blo

260 Daclizumab treatment produced significant reduction in m

261 Add-on daclizumab treatment reduced the number of new or enlarg

262 Finally, we demonstrated that daclizumab treatment significantly enhanced this newly d

263 Steroids were substituted with extended daclizumab use, in combination with tacrolimus and mycop

264 No major adverse events were attributed to daclizumab use.

265 In contrast, daclizumab used at the same dose and schedule was not as

266 Daclizumab used in liver transplant recipients without a

267 tified interleukin-2-receptor induction with daclizumab versus antithymocyte globulin was independent

268 The serum half-life of daclizumab was 20 days, and its administration resulted

269 2 months, patient and graft survival for the daclizumab was 98 and 96 vs. 96 and 94% for the OKT3 gro

270 Administration of daclizumab was accompanied by a dramatic drop in the pop

271 In 1997, daclizumab was approved by the FDA for use in the preven

272 Daclizumab was compared to placebo on a background of cy

273 Daclizumab was efficacious as prophylaxis against acute

274 ntibody 7G7/B6 alone and in combination with daclizumab was evaluated in nonobese diabetic/severe com

275 Daclizumab was generally well tolerated.

276 In the pharmacodynamic substudy, daclizumab was not associated with significant changes i

277 In the pilot study, induction therapy with daclizumab was safe, facilitated improvement in renal fu

278 Daclizumab was very well tolerated and led to a 78% redu

279 ody against the high-affinity IL-2 receptor (daclizumab) was performed in 70 adult, cardiac-transplan

280 junct immunosuppressant (cyclophosphamide or daclizumab) was used for 74 transplantations, adjunct do

281 antibody recognizing interleukin-2 receptor (daclizumab), which has proven to be a successful immunos

282 te on CD30, and humanized anti-Tac antibody (daclizumab), which recognizes CD25, in a murine model of

283 The patient was administered daclizumab without any adverse effects.

284 Daclizumab (Zenapax) identifies the alpha subunit of the

285 Daclizumab (Zenapax, Roche Pharmaceuticals), a humanized

286 (Simulect; Novartis, Basel, Switzerland) and daclizumab (Zenapax; Roche, Basel, Switzerland) combined

287 ctive study was to determine the benefits of daclizumab, (Zenapax, Roche Pharmaceuticals) a humanized