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Dretzke J, Edlin R, Round J, et al. A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease. Southampton (UK): NIHR Evaluation, Trials and Studies Coordinating Centre (UK); 2011 Feb. (Health Technology Assessment, No. 15.6.)

Appendix 6Consistency of trials with licence indications

TABLE 77Consistency of trials with licence indications

Licence indicationStudyPopulation/study characteristics
Adalimumab
  • For treatment of severe, active CD (note: severe is not further defined)
  • In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies
  • Recommended induction dose regimen is 80 mg at week 0 followed by 40 mg at week 2; in case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0, 80 mg at week 2 can be used
  • After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection; patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg every week
Hanauer et al., 2006

CLASSIC I63

INDUCTION
  • Moderate-to-severe CD (CDAI 220–450) ‘despite conventional therapy’
  • Concomitant steroids and immunosuppressants permitted (unclear if all patients resistant or intolerant)
  • Three dose regimens used: 40 mg/20 mg, 80 mg/40 mg, 160 mg/80 mg at weeks 0 and 2 respectively
Sandborn et al., 2007

GAIN64

INDUCTION
  • Moderate-to-severe CD (CDAI 220–450)
  • Concomitant steroids and immunosuppressants permitted (unclear if all patients resistant or intolerant)
  • All patients resistant/intolerant to infliximab
  • Higher induction dose regimen used (160 mg at week 0, 80 mg at week 2)
Colombel et al., 2007

CHARM67

MAINTENANCE
  • Moderate-to-severe CD (CDAI 220–450)
  • Concomitant corticosteroids and immunosuppressants permitted; unclear if all patients resistant or intolerant
  • 40 mg weekly or every other week compared with placebo
Sandborn et al., 2007

CLASSIC II66

MAINTENANCE
  • See CLASSIC I63 for patient characteristics
  • 40 mg weekly or e.o.w. compared with placebo
Infliximab – adults
  • For treatment of severe, active CD (note: severe is not further defined)
  • In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies
  • 5 mg/kg given as an intravenous infusion over a 2-hour period; available data do not support further treatment in patients not responding within 2 weeks
  • Maintenance: additional infusions of 5 mg/kg at 2 and 6 weeks after the initial dose, followed by infusion every 8 weeks
  • Readministration: infusion of 5 mg/kg (within 16 weeks following the last infusion) if signs and symptoms of the disease recur
Targan et al., 199757

INDUCTION
Hanauer et al., 20023 and Rutgeerts et al., 20042

ACCENT I2,3

MAINTENANCE
  • Moderate-to-severe CD, CDAI score between 220–450
  • Patients receiving corticosteroids, immunosuppressive agents, aminosalicylates or antibiotics eligible (unclear if all patients resistant or intolerant)
  • Infusions at week 2 and 6 after the initial dose, then every 8 weeks of 5 mg/kg or 10 mg/kg infliximab
Rutgeerts et al., 199958

(follow-on from Targan et al.57 trial)

MAINTENANCE
  • Moderate-to-severe CD, CDAI score between 220 and 400
  • Concomitant corticosteroids or immunosuppressive agents allowed, patients who had not responded to aminosalicylates eligible
  • States that all patients treatment resistant (not specified which treatment(s) specifically)
  • 10 mg/kg infliximab every 8 weeks
Infliximab – fistulising CD
  • Treatment of fistulising, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy)
  • An initial 5 mg/kg infusion given over a 2-hour period is to be followed with additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion; if a patient does not respond after these three doses, no additional treatment with infliximab should be given
  • In responding patients, the strategies for continued treatment are: additional infusions of 5 mg/kg every 8 weeks or readministration if signs or symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks
Present et al., 199962

INDUCTION
  • Single or multiple draining fistulas
  • Concomitant aminosalicylates, corticosteroids, mercaptopurine, azathioprine or antibiotics permitted (unclear if all patients resistant or intolerant)
  • 5 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6
Sands et al., 2004

ACCENT II65

MAINTENANCE
  • Single or multiple draining fistulas
  • Concomitant aminosalicylates, corticosteroids, mercaptopurine, azathioprine, methotrexate or antibiotics permitted (unclear if all patients resistant or intolerant)
  • 5 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6 (all patients), then 5 mg/kg infliximab every 8 weeks
Infliximab – children
  • For treatment of severe, active Crohn's disease (note severe is not further defined)
  • In paediatric patients aged 6–17 years
  • Who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant or have contraindications to such therapies; Remicade has been studied only in combination with conventional immunosuppressive therapy
  • 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter; some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient
Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment
Baldassano et al., 200346

INDUCTION
Hyams et al., 2007

REACH45

MAINTENANCE
  • Moderate-to-severe, PCDAI ≥ 30
  • Required concomitant treatment with azathioprine, mercaptopurine or methotrexate; permitted: aminosalicylates, oral corticosteroids, antibiotics or enteral nutrition (unclear if all patients resistant or intolerant)
  • 5 mg/kg infliximab at weeks 0, 2 and 6; followed by 5 mg/kg infliximab every 8 or 12 weeks
© 2011, Crown Copyright.

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Cover of A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease
A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease.
Health Technology Assessment, No. 15.6.
Dretzke J, Edlin R, Round J, et al.

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