Table 20Summary of studies assessing subgroups

Author, yearStudy designNDurationDrugPopulationResultsQuality Rating
Age
  Fleischmann et al. 2005360Pooled safety data from RCTs4322NRAnti-TNFPatients with RA, AS, PsANo differences in adverse events between patients older and younger than 65 yearsFair
  Genevay et al. 2007361Retrospective cohort1571Median 3 yearsAnti-TNFPatients with RANo differences in discontinuation rates or change in DAS28 between patients older and younger than 65Fair
  Gottlieb et al. 2005362Pooled analysis of efficacy trialsNR12 weeksAlefaceptPatients with plaque psoriasisNo differences in efficacy and adverse events between patients older and younger than 65 yearsFair
  Takeuchi et al. 2008350Postmarketing surveillance50006 monthsInfliximabPatients with RASignificantly higher risk factor for bacterial pneumonia in patients older than 70 vs. patients in their 50sNA
  Weaver et al. 200642Prospective cohort study369452 weeksEtanercept
Infliximab
Patients with RAPatients younger than 65 years had better responseFair
Race
  Asahina 2010238RCT16924 weeksAdalimumabPatients with plaque psoriasisSignificantly higher response rates in Japanese patients treated with drug compared with placeboFair
  Chen, 200974RCT4712AdalimumabPatients with RANo significant difference in ACR 20 response rates in Taiwanese patients treated with drug compared with placeboFair
  Tsai 2011366RCT12136 weeksUstekinumabPatients with plaque psoriasisSignificantly higher response rates with drug compared with placebo in Taiwanese and Korean patientsFair
  Dixon 2010271Prospective cohort study BSRBR Registry137397345 person-years DMARD, 34025 person-years anti-TNFAdalimumab
Etanercept
Infliximab
Patients with RAIncidence rate of tuberculosis statistically significantly higher in non white patientsFair
Comorbidities
  Chung et al. 2003369RCT15028 weeksInfliximabPatients with CHFInfliximab-treated (10 mg) patients were more likely to die or have heart failure than placebo-treated patientsFair
  Gottlieb et al. 2005362Pooled analysis of efficacy trialsNR12 weeksAlefaceptPatients with plaque psoriasisNo differences in efficacy and adverse events in diabetic and obese patients compared with the general study populationFair
  Dixon et al. 2007334Retrospective cohort study1084016126 person yearsAdalimumab
etanercept, infliximab
Patients with RASignificantly reduced risk of myocardial infarction in responders to anti-TNF treatment compared with non respondersGood
  Schiff et al. 2004363 and Fleischmann et al. 2003368Subgroup analyses of RCT14146 monthsAnakinraPatients with RAIncidence rates of adverse events similar in patients with comorbiditiesFair
  Takeuchi et al. 2008350Postmarketing surveillance50006 monthsInfliximabPatients with RASignificantly higher risk factor for bacterial pneumonia in patients with comorbid respiratory diseaseNA
  Weinblatt et al. 2006353Subgroup analyses of RCTNR52 weeksAbatacept vs. placeboPatients with RAMore SAEs in abatacept-treated patients with COPD or DMFair
  Weisman et al. 2007364RCT53516 weeksEtanercept vs. placeboPatients with RA and ≥1 comorbidityEtanercept associated with small increases in incidence of SAEs in patients with diabetes and COPDFair
  Wolfe et al. 2004328Retrospective cohort study13 1712 yearsAnti-TNFPatients with RAPatients on anti-TNF treatment had a lower rate of CHF than patients on traditional RA therapyFair
Concomitant medications
  Genovese et al. 200450RCT24224 weeksAnakinra + etanerceptPatients with RAPatients treated with both anakinra and etanercept had a 7% rate of serious infection, compared with no infections observed with Etanercept alone.Fair
  Tesser et al. 2004371RCT13996 monthsAnakinraPatients with RAThe adverse event profiles were similar for anakinra and placebo for patients who were or were not taking concomitant antihypertensives, antidiabetic, or statin drugs.Fair
Gender
  Kristensen 2008367Prospective observational study15653 monthsAnti-TNFPatients with RAGender did not influence treatment responseFair
  Takeuchi et al. 2008350Postmarketing surveillance50006 monthsInfliximabPatients with RASignificantly higher risk factor for bacterial pneumonia in men vs. womenNA

Abbreviations: AS, ankylosing spondylitis; BSRBR, British Society for Rheumatology Biologics Register; CD, Crohn’s disease; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; NA, not applicable; NR, not reported; PsA, psoriatic arthritis; RA, rheumatoid arthritis; RCT, randomized controlled trial; TNF, tumor necrosis factor.

From: RESULTS

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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