A systematic review of the effectiveness of adalimumab

More documents

Recommendations

Info

18 Effectiveness Monoclonal Antibody Adalimumab (D2E7) in Rheumatoid Arthritis (ARMADA; DE009), 112 van de Putte (DE011), 113 PREMIER (DE013), 102,109 Keystone (DE019) 114 and Safety Trial of Adalimumab in Rheumatoid Arthritis (STAR; DE031). 115 Data from these reports and additional trial data provided within the company submission are included. A list of these nine trials, the comparators and baseline patient characteristics are shown in Table 1. Trial quality, based on available data, is summarised in Table 2. In general, the trials were of high quality. In most trials patients met agreed disease classification criteria and active RA was defined on the basis of tender and swollen joint counts, and other parameters including ESR, CRP or morning stiffness. Two early-phase trials 116,117 used DAS for inclusion. Stable doses of oral prednisolone (≤ 10 mg per day) and NSAIDs were allowed. Only one trial (PREMIER) 102,109 recruited exclusively early RA patients (disease duration
TABLE 1 Description of included RCTs and baseline patient characteristics: adalimumab No. of Mean Mean Mean On On Mean patients age disease no. of steroids NSAIDs baseline (years) duration previous (%) (%) HAQ (years) DMARDs score Study and description Interventions a DE001 den Broeder et al., 2002 116 Placebo i.v. (one dose) 31 55 11.9 3.7 77 68 1.57 Netherlands and Germany, three centres, Adalimumab 0.5 mg kg –1 i.v. (one dose) 17 54 11.0 3.6 53 94 1.57 double-blind Adalimumab 1 mg kg –1 i.v. (one dose) 18 58 11.2 3.9 78 72 1.85 Adalimumab treatment: single injection Adalimumab 3 mg kg –1 i.v. (one dose) 18 54 10.8 3.9 67 56 1.41 Duration of follow-up: 4 weeks to 3 months b Adalimumab 5 mg kg –1 i.v. (one dose) 18 59 14.5 4.4 78 89 1.61 Adalimumab 10 mg kg –1 i.v. (one dose) 18 53 8.9 3.9 67 72 1.93 DE005 Weisman et al., 2003 118 Placebo i.v. (one dose) + MTX 15 51 15 NR NR NR 1.1 USA and Canada, six centres, double-blind (12.5–25 mg per week, mean 17 mg per week) Adalimumab treatment: single injection c Adalimumab 0.25 mg kg –1 i.v. (one dose) + MTX 9 50 17 1.3 Duration of follow-up: 4 weeks d (12.5–25 mg per week, mean 17 mg per week) Adalimumab 0.5 mg kg –1 i.v. (one dose) + MTX 9 56 13 0.9 (12.5–25 mg per week, mean 13 mg per week) Adalimumab 1 mg kg –1 i.v. (one dose) + MTX 9 51 16 1.5 (12.5–25 mg per week, mean 16 mg per week) Adalimumab 3 mg kg –1 i.v. (one dose) + MTX 9 56 15 1.0 (12.5–25 mg per week, mean 15 mg per week) Adalimumab 5 mg kg –1 i.v. (one dose) + MTX 9 54 18 1.4 (12.5–25 mg per week, mean 18 mg per week) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 DE007 van de Putte et al., 2003 119 Placebo s.c. weekly 70 50 9 3.5 77 80 1.63 Europe, 25 centres, double-blind Adalimumab 20 mg s.c. weekly 72 54 10 4.1 76 76 1.79 Duration of treatment and follow-up: Adalimumab 40 mg s.c. weekly 70 53 10 3.7 70 81 1.74 12 weeks c Adalimumab 80 mg s.c. weekly 72 53 10 3.7 75 78 1.66 DE009, ARMADA Weinblatt et al., 2003 112 Placebo s.c. every other week + MTX 62 56 11 3.0 58 NR 1.64 USA and Canada, 35 centres, double-blind (12.5–25 mg per week, mean 17 mg per week) Duration of treatment and follow-up: Adalimumab 20 mg s.c. every other week + MTX 69 54 13 3.0 1.52 24 weeks (12.5–25 mg per week, mean 17 mg per week) Adalimumab 40 mg s.c. every other week + MTX 67 57 12 2.9 46 1.55 (12.5–25 mg per week, mean 16 mg per week) Adalimumab 80 mg s.c. every other week + MTX 73 56 13 3.1 1.55 (12.5–25 mg per week, mean 17 mg per week) (n = 72) continued 19
Page 1 and 2: A systematic review of the effectiv
Page 3 and 4: A systematic review of the effectiv
Page 5 and 6: Objectives: This report reviews the
Page 7: Glossary and list of abbreviations
Page 10 and 11: viii Glossary and list of abbreviat
Page 13 and 14: Background Rheumatoid arthritis (RA
Page 15: increased risk of serious infection
Page 19 and 20: Summary RA is a common, chronic, in
Page 21 and 22: (IL-2) and interleukin-6 (IL-6), pr
Page 23 and 24: Assessment of response to DMARDs Re
Page 25 and 26: combination with methotrexate or al
Page 27: disease between clinic appointments
Page 30 and 31: 14 Effectiveness in juvenile arthri
Page 32 and 33: 16 Effectiveness adalimumab plus me
Page 36 and 37: 20 TABLE 1 Description of included
Page 38 and 39: 22 TABLE 2 Quality of included RCTs
Page 40 and 41: 24 Effectiveness change in modified
Page 42 and 43: 26 Effectiveness TABLE 4 Meta-analy
Page 44 and 45: 28 Effectiveness Review: Adalimumab
Page 46 and 47: 30 Effectiveness Review: Adalimumab
Page 48 and 49: 32 TABLE 6 Effectiveness Descriptio
Page 50 and 51: 34 TABLE 6 Effectiveness Descriptio
Page 52 and 53: 36 TABLE 7 Effectiveness Quality of
Page 54 and 55: 38 Effectiveness etanercept trials.
Page 56 and 57: 40 Effectiveness TABLE 9 Summary of
Page 58 and 59: 42 Effectiveness Review: Etanercept
Page 70 and 71: 54 Effectiveness TABLE 11 Summary o
Page 72 and 73: 56 TABLE 12 Description of included
Page 74 and 75: 58 TABLE 13 Quality of included RCT
Page 76 and 77: 60 Effectiveness per week and escal
Page 78 and 79: 62 Effectiveness significant advant
Page 80 and 81: 64 Effectiveness Review: Infliximab
Page 82 and 83: 66 Effectiveness Review: Infliximab
Page 84 and 85:
68 Effectiveness FIGURE 44 Malignan
Page 86 and 87:
70 TABLE 17 Effectiveness Summary o
Page 89 and 90:
Summary of review of existing econo
Page 91 and 92:
TABLE 20 Summary of published ICERs
Page 93 and 94:
TABLE 21 Published etanercept econo
Page 95 and 96:
TABLE 23 Published economic analyse
Page 97 and 98:
TABLE 25 Treatment sequences: adali
Page 99 and 100:
management of RA, i.e. 1st and 2nd
Page 101 and 102:
To estimate the long-term consequen
Page 103 and 104:
TABLE 32 TNF inhibitors as last act
Page 105 and 106:
TABLE 34 Basic structure of the mod
Page 107 and 108:
een quit on grounds of toxicity, ad
Page 109 and 110:
TABLE 39 Strategy set: adalimumab a
Page 111 and 112:
TABLE 43 Beta distributions for HAQ
Page 113 and 114:
TABLE 44 Early cessation of DMARDs:
Page 115 and 116:
TABLE 46 Unit costs for tests and v
Page 117 and 118:
following properties, according to
Page 119 and 120:
TABLE 52 Base case: TNF inhibitors
Page 121 and 122:
TABLE 54 Base case: TNF inhibitors
Page 123 and 124:
TABLE 59 Third TNF inhibitor follow
Page 125 and 126:
TABLE 65 Sensitivity analyses: TNF
Page 127 and 128:
TABLE 67 Sensitivity analyses: TNF
Page 129:
The substantial economic impact of
Page 133 and 134:
Summary Effectiveness: principal fi
Page 135 and 136:
inhibitors, although the incrementa
Page 137 and 138:
introduce bias which generally exag
Page 139:
Adalimumab, etanercept and inflixim
Page 143 and 144:
1. Jobanputra P, Barton P, Bryan S,
Page 145 and 146:
46. Young A, Dixey J, Cox N, Davies
Page 147 and 148:
tumor necrosis factor therapy in th
Page 149 and 150:
arthritis: a 12-week, double-blind,
Page 151 and 152:
171. Geborek P, Crnkic M, Petersson
Page 153 and 154:
216. Schotte H, Willeke P, Mickholz
Page 155 and 156:
The Health Assessment Questionnaire
Page 157 and 158:
Cochrane Library (CENTRAL) 2005 Iss
Page 159 and 160:
Appendix 3 © Queen’s Printer and
Page 161:
TABLE 69 Studies excluded from clin
Page 164 and 165:
148 Appendix 4 TABLE 71 Meta-analys
Page 166 and 167:
150 Appendix 4 TABLE 73 Meta-analys
Page 168 and 169:
152 Appendix 4 Infliximab versus pl
Page 170 and 171:
154 Appendix 4 Infliximab plus MTX
Page 173:
Ovid MEDLINE(R) 1966 to February we
Page 177 and 178:
Appendix 8 © Queen’s Printer and
Page 179 and 180:
TABLE 79 Wong et al., 2002 161 © Q
Page 181 and 182:
TABLE 80 Kobelt et al., 2003 162 (c
Page 183 and 184:
TABLE 82 Brennan et al., 2004 160
Page 185 and 186:
Page 187 and 188:
TABLE 85 Bansback et al., 2005 166
Page 189:
Page 192 and 193:
176 Appendix 9 TABLE 89 Strategy se
Page 195 and 196:
Extensive sensitivity analysis was
Page 197 and 198:
TABLE 96 Variation 1: TNF inhibitor
Page 199 and 200:
TABLE 99 Variation 2: TNF inhibitor
Page 201 and 202:
TABLE 102 Variation 3: TNF inhibito
Page 203 and 204:
Page 205 and 206:
Page 207 and 208:
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
TABLE 132 Variation 10: TNF inhibit
Page 223 and 224:
Page 225 and 226:
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243:
Page 247 and 248:
Volume 1, 1997 No. 1 Home parentera
Page 249 and 250:
No. 3 Screening for sickle cell dis
Page 251 and 252:
No. 25 A rapid and systematic revie
Page 253 and 254:
No. 11 First and second trimester a
Page 255 and 256:
No. 23 Clinical effectiveness and c
Page 257 and 258:
No. 28 Outcomes of electrically sti
Page 259:
No. 28 Adefovir dipivoxil and pegyl
Page 262 and 263:
246 Health Technology Assessment Pr
Page 264:
248 Health Technology Assessment Pr
show all

A systematic review of the effectiveness of adalimumab

Create successful ePaper yourself

Delete template?

Save as template?