Table 1

Summary of studies

StudyPhaseDesignPatientsAdalimumab dosesConcomitant DMARDTreatment durationStudy sites
SJC, swollen joint count; TJC, tender joint count; CRP, C reactive protein; HAQ, Health Assessment Questionnaire; DMARD, disease modifying antirheumatic drug; MTX, methotrexate; DAS, Disease Activity Score; iv, intravenously; and sc, subcutaneously.
DE001/003IRandomised, double blind, placebo controlled for first and second injection, and open label thereafterPatient number = 120Adalimumab 0.5 to 10.0 mg/kg iv every 2 weeksNone12 monthsEurope
Mean disease duration = 11.5 y
Mean DAS = 5.3
Mean previous DMARDs = 3.9
DE004IRandomised, double blind, placebo controlled for first 3 months and open label for next 3 monthsPatient number = 24Adalimumab 0.5 mg/kg sc weeklyNone6 monthsEurope
Mean disease duration = 10.1 y
Mean DAS = 5.3
Mean SJC = 19.9
Mean TJC = 21.4
DE007IIRandomised, double blind, placebo controlledPatient number = 283Adalimumab 20 mg, 40 mg, or 80 mg sc weeklyNone12 weeksEurope
Median age = 53 y
Median disease duration = 8 y
Median SJC = 18
Median TJC = 30
Median ESR = 45 mm/h
Median CRP = 5.1 mg/dl
Median previous DMARDs = 4
DE009IIRandomised, double blind, placebo controlledPatient number = 271Adalimumab 20 mg, 40 mg, or 80 mg sc every other weekMTX24 weeksNorth America
Mean age = 55.1 y
Mean disease duration = 12.3 y
76.8% female
81% RF positive
Mean SJC = 17.2
Mean TJC = 28.9
Mean CRP = 2.7 mg/dl
Mean HAQ = 1.6
Mean previous DMARDs = 3
Mean MTX dose = 16.8 mg/wk
DE010IRandomised, double blind, placebo controlled for first and second injection and open label thereafterPatient number = 54Adalimumab 1.0 mg/kg sc or iv weekly to monthlyMTX24 monthsEurope
Median DAS = 4.72
Median Ritchie Index = 16.0
Median SJC = 19.0
Mean MTX dose = 16.0 mg/wk