Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults

151 Pages·2007·0.77 MB·English

This report is based on research conducted by the RTI-University of North Carolina
Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research
and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0016). The findings and
conclusions in this document are those of the author(s), who are responsible for its contents;
the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no
statement in this report should be construed as an official position of the Agency for
Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

This report is intended as a reference and not as a substitute for clinical judgment. Anyone
who makes decisions concerning the provision of clinical care should consider this report in
the same way as any medical reference and in conjunction with all other pertinent
information.

This report may be used, in whole or in part, as the basis for development of clinical practice
guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage
policies. AHRQ or U.S. Department of Health and Human Services endorsement of such
derivative products may not be stated or implied.
Comparative Effectiveness Review
Number 11

Comparative Effectiveness of Drug Therapy for
Rheumatoid Arthritis and Psoriatic Arthritis in Adults

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
540 Gaither Road
Rockville, MD 20850
www.ahrq.gov

Contract No. 290-02-0016

Prepared by:

RTI-University of North Carolina Evidence-based Practice Center

Investigators
Katrina E. Donahue M.D., M.P.H.
Gerald Gartlehner, M.D., M.P.H.
Daniel E. Jonas, M.D., M.P.H.
Linda J. Lux, M.P.A.
Patricia Thieda, M.A.
Beth Jonas, MD, M.P.H.
Richard A. Hansen, Ph.D.
Laura C. Morgan, M.A.
Stacey C. Williams, B.S.
Kathleen N. Lohr, Ph.D.

AHRQ Publication No. 08-EHC004-EF
November 2007
This document is in the public domain and may be used and reprinted without permission except
those copyrighted materials noted for which further reproduction is prohibited without the
specific permission of copyright holders.

None of the investigators has any affiliations or financial involvement that conflicts with
the material presented in this report.

Suggested citation:
Donahue KE, Gartlehner G, Jonas DE, Lux LJ, Thieda P, Jonas B, Hansen RA, Morgan LC, Williams
SC, Lohr KN. Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic
Arthritis in Adults. Comparative Effectiveness Review No. 11. (Prepared by RTI-University of North
Carolina Evidence-based Practice Center under Contract No. 290-02-0016.) Rockville, MD: Agency for
Healthcare Research and Quality. November 2007. Available at:
www.effectivehealthcare.ahrq.gov/reports/final.cfm.

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Preface

The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care
Program as part of its mission to organize knowledge and make it available to inform decisions
about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003, Congress directed AHRQ to conduct and support research on the comparative
outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health
care services to meet the needs of Medicare, Medicaid, and the State Children’s Health Insurance
Program (SCHIP).

AHRQ has an established network of Evidence-based Practice Centers (EPCs) that produce
Evidence Reports/Technology Assessments to assist public- and private-sector organizations in
their efforts to improve the quality of health care. The EPCs now lend their expertise to the
Effective Health Care Program by conducting Comparative Effectiveness Reviews of
medications, devices, and other relevant interventions, including strategies for how these items
and services can best be organized, managed, and delivered.

Systematic reviews are the building blocks underlying evidence-based practice; they focus
attention on the strengths and limits of evidence from research studies about the effectiveness
and safety of a clinical intervention. In the context of developing recommendations for practice,
systematic reviews are useful because they define the strengths and limits of the evidence,
clarifying whether assertions about the value of the intervention are based on strong evidence
from clinical studies. For more information about systematic reviews, see
http://effectivehealthcare.ahrq.gov/reference/purpose.cfm.

AHRQ expects that Comparative Effectiveness Reviews will be helpful to health plans,
providers, purchasers, government programs, and the health care system as a whole. In addition,
AHRQ is committed to presenting information in different formats so that consumers who make
decisions about their own and their family’s health can benefit from the evidence.

Transparency and stakeholder input are essential to the Effective Health Care Program. Please
visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports
or to join an e-mail list to learn about new program products and opportunities for input.
Comparative Effectiveness Reviews will be updated regularly.

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Acknowledgments
We acknowledge the continuing support of Beth Collins-Sharp, Ph.D., R.N., Director of the
AHRQ Evidence-based Practice Center (EPC) Program, and Carmen Kelly, Pharm.D., R.Ph., the
AHRQ Task Order Officer for this project.
The investigators deeply appreciate the considerable support, commitment, and contributions of
the EPC team staff at RTI International and the University of North Carolina (UNC). We would
particularly acknowledge Timothy Carey, M.D., M.P.H., for insightful comments on the first
draft and helpful suggestions throughout the project, and Lynn Whitener, Dr.P.H., M.S.L.S., our
EPC Librarian. We also express our gratitude to RTI staff Loraine Monroe, our EPC Document
Specialist, Tammeka Swinson, Research Analyst, and Jennifer Drolet, M.A., editor.

AHRQ Contacts

Beth A. Collins-Sharp, Ph.D., R.N. Carmen Kelly, Pharm.D., R.Ph.
Director Task Order Officer
Evidence-based Practice Center Program Evidence-based Practice Center Program
Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality
Rockville, MD Rockville, MD

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Contents

Executive Summary................................................................................................................ES-1

Introduction...................................................................................................................................1
Background..........................................................................................................................1
Causes and Diagnosis..........................................................................................................1
Rheumatoid Arthritis (RA)...........................................................................................1
Psoriatic Arthritis (PsA)................................................................................................2
Treatment of Rheumatoid Arthritis and Psoriatic Arthritis.................................................3
Overview.......................................................................................................................3
Disease-Specific Treatments.........................................................................................7
Scope and Key Questions....................................................................................................8
Organization of the Report...................................................................................................9

Methods........................................................................................................................................11
Topic Development............................................................................................................11
Literature Search.........................................................................................................11
Study Selection..................................................................................................................12
Data Extraction...........................................................................................................12
Quality Assessment.....................................................................................................13
Applicability Assessment...................................................................................................13
Rating Strength of a Body of Evidence.............................................................................14
Data Synthesis....................................................................................................................15

Results..........................................................................................................................................17
Key Question 1: Reductions in Symptoms, Limitations of Disease Progression, and
Maintenance of Remission.................................................................................................19
Rheumatoid Arthritis: Overview.................................................................................30
Rheumatoid Arthritis: Key Points...............................................................................30
Rheumatoid Arthritis: Detailed Analysis....................................................................32
Psoriatic Arthritis: Overview......................................................................................45
Psoriatic Arthritis: Key Points....................................................................................47
Psoriatic Arthritis: Detailed Analysis.........................................................................47
Key Question 2: Functional Capacity and Quality of Life................................................49
Rheumatoid Arthritis: Overview.................................................................................50
Rheumatoid Arthritis: Key Points...............................................................................58
Rheumatoid Arthritis: Detailed Analysis....................................................................60
Psoriatic Arthritis: Overview......................................................................................68
Psoriatic Arthritis: Key Points....................................................................................69
Psoriatic Arthritis: Detailed Analysis.........................................................................69
Key Question 3: Harms, Tolerability, Adverse Effects or Adherence..............................70
Rheumatoid Arthritis: Overview.................................................................................71
Rheumatoid Arthritis: Key Points...............................................................................74
Detailed Analysis........................................................................................................76
Psoriatic Arthritis: Overview......................................................................................97
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Psoriatic Arthritis: Key Points....................................................................................98
Psoriatic Arthritis: Detailed Analysis.........................................................................98
Key Question 4: Benefits and Harms for Selected Populations........................................99
Rheumatoid Arthritis: Overview.................................................................................99
Key Points.................................................................................................................100
Detailed Analysis......................................................................................................103

Discussion...................................................................................................................................107
Key Findings....................................................................................................................112
Rheumatoid Arthritis................................................................................................112
Psoriatic Arthritis......................................................................................................115
Future Research...............................................................................................................115
Rheumatoid Arthritis................................................................................................115
Psoriatic Arthritis......................................................................................................116

References..................................................................................................................................119

Tables

1. ACR criteria for the diagnosis of rheumatoid arthritis...............................................................2
2. CASPAR criteria for the diagnosis of psoriatic arthritis............................................................3
3. Pharmaceutical treatments for rheumatoid arthritis and psoriatic arthritis.................................5
4. Route, labeled use, and usual dose of treatments for rheumatoid arthritis and psoriatic
arthritis.......................................................................................................................................6
5. Outcome measures and study eligibility criteria.........................................................................9
6. Criteria for effectiveness studies...............................................................................................14
7. Definitions of the grades of overall strength of evidence.........................................................14
8. Number of head-to-head trials or studies by drug comparison for rheumatoid arthritis..........18
9. Diagnostic scales and quality-of-life instruments.....................................................................19
10. Study characteristics, symptom response, and quality ratings of studies in adults with
rheumatoid arthritis..................................................................................................................20
11. Study characteristics and radiographic joint damage in adults with rheumatoid arthritis.......26
12. Study characteristics, symptom response, and quality ratings of studies in adults with
psoriatic arthritis......................................................................................................................45
13. Study characteristics and radiographic joint damage in adults with psoriatic arthritis............46
14. Interventions, functional capacity, health-related quality of life, and quality ratings of studies
in adults with rheumatoid arthritis...........................................................................................50
15. Interventions, functional capacity, health-related quality of life and quality ratings of studies
in adults with psoriatic arthritis................................................................................................68
16. Drug toxicities and Food and Drug Administration warnings.................................................71
17. Comparative harms in patients with rheumatoid arthritis treated with corticosteroids...........76
18. Comparative harms in patients with rheumatoid arthritis treated with synthetic DMARDs...78
19. Comparative harms in patients with rheumatoid arthritis and treated with biologic
DMARDs.................................................................................................................................83
20. Studies assessing adherence in patients with rheumatoid arthritis..........................................96
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21. Studies assessing adverse events and discontinuation rates during blinded portion of studies
of psoriatic arthritis..................................................................................................................97
22. Adherence in patients with psoriatic arthritis..........................................................................99
23. Study characteristics, outcomes, and quality ratings of adult subpopulations with rheumatoid
arthritis: by age......................................................................................................................100
24. Study characteristics, outcomes, and quality ratings of adult subpopulations with rheumatoid
arthritis and other conditions.................................................................................................102
25. Study characteristics, outcomes, and quality ratings of studies of pregnant women.............103
26. Summary of findings with strength of evidence: rheumatoid arthritis..................................107
27. Summary of findings with strength of evidence: psoriatic arthritis.......................................111

Figures

Figure 1. Results of literature search............................................................................................17
Figure 2. Adjusted indirect comparisons of biologic DMARDs for ACR 20 response rates.......39
Figure 3. Adjusted indirect comparisons of biologic DMARDs for ACR 50 response rates.......40

Appendixes

Appendix A: Peer Reviewers and Acknowledgments
Appendix B: Search Strings
Appendix C: Studies in an Included Meta-Analysis
Appendix D: Excluded Studies
Appendix E: Evidence Tables
Appendix F: Abstract-Only Studies
Appendix G: Quality Criteria
Appendix H: Characteristics of Studies With Poor Internal Validity
Appendix I: Clinical and Self-Reported Scales and Instruments Commonly Used in Studies of
Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis

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