Table 1Included interventions

Generic nameTrade name ManufacturerMechanism of actionIndicationDosage and administration approved by the FDA
AbataceptOrencia®
Bristol Myers
Squibb
CTLA 4-IgRheumatoid arthritisIntravenous infusion dosed according to body weight (<60 kg = 500 mg; 60–100 kg = 750 mg; >100 kg = 1000 mg); dose repeated at 2 weeks and 4 weeks after initial dose, and every 4 weeks thereafter.
Following single intravenous loading dose according to body weight specified above, the first 125 mg subcutaneous injection within 1 day, followed by 125 mg once weekly.
Patients unable to receive an infusion may initiate weekly subcutaneous injections without an intravenous loading dose.
Patients transitioning from intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of next scheduled intravenous dose.
Juvenile rheumatoid arthritisa (6 years and older)See Canadian product label
Juvenile idiopathic arthritis (6 years and older)10 mg/kg for patients <75 kg; adults schedule for patients >75kg (maximum dose 1000 mg) on weeks 0, 2, and 4 and then every 4 weeks thereafter.
AdalimumabHumira®
Abbott
TNF InhibitorRheumatoid arthritis40 mg every other week as subcutaneous injection; may increase to 40 mg weekly for adalimumab monotherapy.
Psoriatic arthritis, ankylosing spondylitis40 mg every other week as subcutaneous injection.
Juvenile idiopathic arthritisb (4 years of age and older)15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week.
≥ 30 kg (66 lbs): 40 mg every other week.
Crohn’s diseaseInitial subcutaneous dose (Day 1) 160 mg (four 40 mg injections in 1 day or two 40 mg injections daily for 2 consecutive days), followed by 80 mg 2 weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.
Plaque psoriasis80 mg initial subcutaneous dose followed by 40 mg every other week starting 1 week after initial dose. 15 mg given once weekly as an intramuscular injection.
AlefaceptAmevive®
Astellas
CD2 antagonistPlaque psoriasisTreatment should be continued for 12 weeks; re- treatment with an additional 12 week course may be initiated provided that CD4+ T lymphocytes counts are >250 cells/μL and a 12-week interval has passed since the end of the initial treatment cycle.
AnakinraKineret®
Biovitrum/Amgen
IL-1 receptor antagonistRheumatoid arthritis100 mg daily as subcutaneous injection; dose should be decreased to 100 mg every other day in renal insufficiency.
Certolizumab pegolCimzia®
UCB, Inc
TNF InhibitorRheumatoid arthritis400 mg subcutaneous injection initially and at weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered.
Crohn’s diseaseb400 mg subcutaneous injection initially and at weeks 2 and 4. If response occurs 400 mg subcutaneously every 4 weeks.
EtanerceptEnbrel®
Amgen
Pfizer
Immunex
TNF InhibitorRheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis50 mg once weekly as subcutaneous injection.
Juvenile idiopathic arthritis (2–17 years)c0.8 mg/kg weekly (maximum 50 mg weekly), given as 1 or 2 subcutaneous injections.
Plaque psoriasis50 mg given twice weekly as a subcutaneous injection for 3 months, followed by 50 mg weekly.
GolimumabSimponi®
Janssen
Biotech
TNF InhibitorRheumatoid arthritis50 mg subcutaneous injection once a month in combination with methotrexate.d
Psoriatic arthritis, ankylosing spondylitis50 mg subcutaneous injection once a month with or without methotrexate or other DMARDs.e
InfliximabRemicade®
Janssen
Biotech
TNF InhibitorRheumatoid arthritisAdult: 3 mg/kg intravenous induction at 0, 2, and 6 weeks with methotrexate followed by maintenance every 8 weeks thereafter; may increase to maximum of 10 mg/kg or treating as often as every 4 weeks.
Crohn’s disease5 mg/kg intravenous infusion at 0, 2, and 6 weeks followed by maintenance every 8 weeks thereafter; may increase to 10 mg/kg.
Pediatric f,g: 5 mg/kg intravenous induction at 0, 2, and 6 weeks followed by maintenance every 8 weeks thereafter.
Psoriatic arthritis5 mg/kg intravenous induction at 0, 2, and 6 weeks followed by maintenance every 8 weeks thereafter, with or without methotrexate.
Ankylosing spondylitis5 mg/kg intravenous induction at 0, 2, and 6 weeks followed by maintenance every 6 weeks thereafter.
Active ulcerative colitis5 mg/kg intravenous induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter.
Pediatricf: 5 mg/kg intravenous induction regimen at 0, 2, and 6 weeks followed by maintenace regimen of 5 mg/kg every 8 weeks.
Plaque psoriasis5 mg/kg intravenous induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter.
NatalizumabTysabri®
Biogen-Idec
Anti-alpha-4 integrin subunitCrohn’s diseaseb300 mg intravenous infusion every 4 weeks.
RituximabRituxan®
Genentech
Hoffman-La
Rocheh
Anti-CD 20aRheumatoid arthritisTwo 1000 mg intravenous infusion on days 1 and 15 in combination with methotrexate. Subsequent courses administered every 24 weeks or based on clinical evaluation but not sooner than every 16 weeks.
TocilizumabActemra®
Genentech
IL-6 receptor monoclonal antibodyRheumatoid arthritisStart dose 4 mg/kg, increase up to 8 mg/kg given every 4 weeks with or without DMARD. Increase to 8 mg/kg based on clinical response. Dose exceeding 800 mg/infusion not recommended.
Systemic juvenile idiopathic arthritisb (2 years and older)Body weight <30 kg: 12 mg/kg intravenous infusion every 2 weeks.
Body weight ≥30 kg: 8 mg/kg every 2 weeks.
UstekinumabStelara®
Janssen
Biotech
IL-12 and IL-23 monoclonal antibodyPlaque psoriasisBody weight ≤100 kg (220 lbs), recommended dose 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks by subcutaneous injection
Body weight >100 kg (220 pounds), recommended dose 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Abbreviations: AS, ankylosing spondylitis; DMARD, disease-modifying antirheumatic drug; FDA, US Food and Drug Administration; JIA, juvenile idiopathic arthritis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis.

a

Approved only in Canada

b

Not approved in Canada

c

In Canada, pediatric: 4–17 years

d

Not approved in combination with methotrexate in Canada

e

Not approved in combination with methotrexate/other DMARDs in Canada

f

In United States., pediatric: 6–17 years

g

In Canada, pediatric: ≥9 years

h

Manufacturer in Canada

Note: Table 1 provides manufacturer and approved indications in the United States and Canada and dosage and administration information in the United States relative to indications covered in this report. Readers should refer to the Health Canada product monograph of individual drug products for dosing information for Canada.

From: INTRODUCTION

Cover of Drug Class Review: Targeted Immune Modulators
Drug Class Review: Targeted Immune Modulators: Final Update 3 Report [Internet].
Thaler KJ, Gartlehner G, Kien C, et al.
Portland (OR): Oregon Health & Science University; 2012 Mar.
Copyright © 2012, Oregon Health & Science University, Portland, Oregon.

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