Matching-adjusted indirect comparison of adalimumab vs etanercept and infliximab for the treatment of psoriatic arthritis

Abstract Objectives: No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap. Methods: Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests. Results: After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p < 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p < 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p < 0.05). Conclusion: Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points. Key limitations: The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.

[1]  D. Spiegelhalter,et al.  Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis: a systematic review and economic evaluation. , 2011, Health technology assessment.

[2]  Michele Tarsilla Cochrane Handbook for Systematic Reviews of Interventions , 2010, Journal of MultiDisciplinary Evaluation.

[3]  B. Tom,et al.  A longitudinal study of the effect of disease activity and clinical damage on physical function over the course of psoriatic arthritis: Does the effect change over time? , 2007, Arthritis and rheumatism.

[4]  D G Altman,et al.  Indirect comparisons of competing interventions. , 2005, Health technology assessment.

[5]  Gordon Guyatt,et al.  Meta-analyses of therapies for postmenopausal osteoporosis. IX: Summary of meta-analyses of therapies for postmenopausal osteoporosis. , 2002, Endocrine reviews.

[6]  W. Eyler,et al.  PSORIATIC ARTHRITIS. , 1965, Henry Ford Hospital medical bulletin.

[7]  Eric Q. Wu,et al.  Comparative Effectiveness Without Head-to-Head Trials , 2012, PharmacoEconomics.

[8]  Robert L. Wolpert,et al.  Statistical Inference , 2019, Encyclopedia of Social Network Analysis and Mining.

[9]  R. Stern,et al.  Epidemiology of psoriatic arthritis in the population of the United States. , 2005, Journal of the American Academy of Dermatology.

[10]  A. Kavanaugh,et al.  Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial , 2005, Annals of the rheumatic diseases.

[11]  D. Veale,et al.  Psoriatic Arthritis Management Update – Biotherapeutic Options , 2009, The Journal of Rheumatology.

[12]  D. Gladman,et al.  Longitudinal study of clinical and radiological progression in psoriatic arthritis. , 1990, The Journal of rheumatology.

[13]  P. Helliwell,et al.  Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. , 2001, The Journal of rheumatology.

[14]  S. Gabriel,et al.  The epidemiology of psoriatic arthritis in Olmsted County, Minnesota, USA, 1982-1991. , 2000, The Journal of rheumatology.

[15]  J. Sharp,et al.  Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. , 2004, Arthritis and rheumatism.

[16]  O. Jd,et al.  Prospective analysis of psoriatic arthritis in patients hospitalized for psoriasis. , 1978 .

[17]  A. Kavanaugh,et al.  Treatment of psoriatic arthritis with biological agents. , 2010, Seminars in cutaneous medicine and surgery.

[18]  M. Genovese,et al.  Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy. , 2007, Journal of Rheumatology.

[19]  D. Gladman,et al.  Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. , 2005, Arthritis and rheumatism.

[20]  D. Symmons,et al.  Risks and benefits of tumor necrosis factor-alpha inhibitors in the management of psoriatic arthritis: systematic review and metaanalysis of randomized controlled trials. , 2008, The Journal of rheumatology.

[21]  D. Gladman,et al.  Health-related quality of life of patients with psoriatic arthritis: a comparison with patients with rheumatoid arthritis. , 2001, Arthritis and rheumatism.

[22]  D. Gladman,et al.  Validating the SF-36 health survey questionnaire in patients with psoriatic arthritis. , 1997, The Journal of rheumatology.

[23]  A. Migliore,et al.  Indirect comparison of etanercept, infliximab, and adalimumab for psoriatic arthritis: mixed treatment comparison using placebo as common comparator , 2011, Clinical Rheumatology.

[24]  A. Phillips Trial and error: cross-trial comparisons of antiretroviral regimens , 2003, AIDS.

[25]  S D Walter,et al.  The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. , 1997, Journal of clinical epidemiology.

[26]  R. Queiro-Silva,et al.  A polyarticular onset predicts erosive and deforming disease in psoriatic arthritis , 2003, Annals of the rheumatic diseases.

[27]  Mei Lu,et al.  Comparative effectiveness research using matching‐adjusted indirect comparison: an application to treatment with guanfacine extended release or atomoxetine in children with attention‐deficit/hyperactivity disorder and comorbid oppositional defiant disorder , 2012, Pharmacoepidemiology and drug safety.

[28]  B. Thiers Adalimumab for the Treatment of Patients With Moderately to Severely Active Psoriatic Arthritis: Results of a Double-blind, Randomized, Placebo-controlled TrialMease PJ, for the Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group (Seattle Rheumatology Associates; et al) Arthritis Rheum , 2006 .

[29]  Keith Abrams,et al.  Use of Indirect and Mixed Treatment Comparisons for Technology Assessment , 2012, PharmacoEconomics.

[30]  J. J. Bunim,et al.  Primer on the rheumatic diseases. , 1949, Journal of the American Medical Association.

[31]  D. Leonard,et al.  Prospective analysis of psoriatic arthritis in patients hospitalized for psoriasis. , 1978, Mayo Clinic proceedings.