Comparative efficacy of biologics as monotherapy and in combination with methotrexate on patient reported outcomes (PROs) in rheumatoid arthritis patients with an inadequate response to conventional DMARDs - a systematic review and network meta-analysis

Health and Quality of Life Outcomes

Volumn 12, Issue 1, 2014, Pages

  Jansen, Jeroen P ^a,b   Buckley, Felicity ^a   Dejonckheere, Fred ^c   Ogale, Sarika ^d  

^a MAPI GROUP   (Netherlands)

^b TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d GENENTECH INC   (United States)

Author keywords

Biologics; Indirect comparison; Network meta analysis; Patient reported outcomes; Rheumatoid arthritis

Indexed keywords

ABATACEPT; ADALIMUMAB; BIOLOGICAL PRODUCT; CERTOLIZUMAB PEGOL; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; METHOTREXATE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; TOCILIZUMAB; ANTIBODY CONJUGATE; ANTIRHEUMATIC AGENT; IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN G; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; MACROGOL DERIVATIVE; MONOCLONAL ANTIBODY; TNFR-FC FUSION PROTEIN; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR RECEPTOR;

ARTICLE; COMPARATIVE EFFECTIVENESS; DISEASE ACTIVITY; DRUG EFFICACY; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; META ANALYSIS; MONOTHERAPY; PAIN ASSESSMENT; QUALITY OF LIFE; RHEUMATOID ARTHRITIS; SHORT FORM 36; SYSTEMATIC REVIEW; THERAPY EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; ANTAGONISTS AND INHIBITORS; ARTHRALGIA; ARTHRITIS, RHEUMATOID; BAYES THEOREM; COMPLICATION; DRUG COMBINATION; FEMALE; MALE; MIDDLE AGED; OUTCOME ASSESSMENT;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRALGIA; ARTHRITIS, RHEUMATOID; BAYES THEOREM; BIOLOGICAL PRODUCTS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOCONJUGATES; IMMUNOGLOBULIN FAB FRAGMENTS; IMMUNOGLOBULIN G; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; MALE; METHOTREXATE; MIDDLE AGED; PATIENT OUTCOME ASSESSMENT; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; RECEPTORS, TUMOR NECROSIS FACTOR; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84922564119     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-12-102     Document Type: Article

References (62)

1. Whalley D, McKenna SP, de Jong Z, van der Heijde D. Quality of life in rheumatoid arthritis. Br J Rheumatol 1997, 36:884-888.
2. Cole JC, Motivala SJ, Khanna D, Lee JY, Paulus HE, Irwin MR. Validation of single-factor structure and scoring protocol for the Health Assessment Questionnaire-Disability Index. Arthritis Rheum 2005, 53:536-542.
3. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, Paulus HE, Mudano A, Pisu M, Elkins-Melton M, Outman R, Allison JJ, Suarez Almazor M, Bridges SL, Chatham WW, Hochberg M, MacLean C, Mikuls T, Moreland LW, O'Dell J, Turkiewicz AM, Furst DE. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008, 59:762-784.
4. Luqmani R, Hennell S, Estrach C, Basher D, Birrell F, Bosworth A, Burke F, Callaghan C, Candal-Couto J, Fokke C, Goodson N, Homer D, Jackman J, Jeffreson P, Oliver S, Reed M, Sanz L, Stableford Z, Taylor P, Todd N, Warburton L, Washbrook C, Wilkinson M, . British Society for Rheumatology British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of rheumatoid arthritis (after the first 2 years). Rheumatology (Oxford) 2009, 48:436-439. British Society for Rheumatology.
5. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, Furst D, Goldsmith C, Kieszak S, Lightfoot R. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993, 36:729-740.
6. Ramey DR, Raynauld JP, Fries JF. The health assessment questionnaire 1992: status and review. Arthritis Care Res 1992, 5(3):119-129.
7. Ware JE, Kosinski M, Keller SK. SF-36 Physical and Mental Health Summary Scales: a User's Manual 1994, Boston: New England Medical Center, The Health Institute.
8. Strand V, Singh JA. Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2008, 14:234-254.
9. Mathias SD, Colwell HH, Miller DP, Moreland LW, Buatti M, Wanke L. Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo. Clin Ther 2000, 22:128-139.
10. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, Weaver AL, Keystone EC, Furst DE, Mease PJ, Ruderman EM, Horwitz DA, Arkfeld DG, Garrison L, Burge DJ, Blosch CM, Lange ML, McDonnell ND, Weinblatt ME. Etanercept therapy in rheumatoid arthritis A randomized, controlled trial. Ann Intern Med 1999, 130:478-486.
11. van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, Settas L, Bijlsma JW, Todesco S, Dougados M, Nash P, Emery P, Walter N, Kaul M, Fischkoff S, Kupper H. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004, 63:508-516.
12. Listing J, Strangfeld A, Rau R, Kekow J, Gromnica-Ihle E, Klopsch T, Demary W, Burmester GR, Zink A. Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low-results from RABBIT, the German biologics register. Arthritis Res Ther 2006, 8:R66.
13. Heiberg MS, Koldingsnes W, Mikkelsen K, Rødevand E, Kaufmann C, Mowinckel P, Kvien TK. The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthritis Rheum 2008, 59:234-240.
14. Soliman MM, Ashcroft DM, Watson KD, Lunt M, Symmons DP, Hyrich KL. Impact of concomitant use of DMARDs on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2011, 70:583-589.
15. Turkstra E, Ng SK, Scuffham PA. A mixed treatment comparison of the short-term efficacy of biologic disease modifying anti-rheumatic drugs in established rheumatoid arthritis. Curr Med Res Opin 2011, 27:1885-1897.
16. Schmitz S, Adams R, Walsh CD, Barry M, Fitzgerald O. A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach. Ann Rheum Dis 2012, 71(2):225-230.
17. Launois R, Avouac B, Berenbaum F, Blin O, Bru I, Fautrel B, Joubert JM, Sibilia J, Combe B. Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis. J Rheumatol 2011, 38:835-845.
18. Devine EB, Alfonso-Cristancho R, Sullivan SD. Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparisons approach. Pharmacotherapy 2011, 31:39-51.
19. Salliot C, Finckh A, Katchamart W, Lu Y, Sun Y, Bombardier C, Keystone E. Indirect comparisons of the efficacy of biological antirheumatic agents in rheumatoid arthritis in patients with an inadequate response to conventional disease-modifying antirheumatic drugs or to an anti-tumour necrosis factor agent: a meta-analysis. Ann Rheum Dis 2011, 70:266-271.
20. Bergman GJ, Hochberg MC, Boers M, Wintfeld N, Kielhorn A, Jansen JP. Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs. Semin Arthritis Rheum 2010, 39:425-441.
21. Singh JA, Christensen R, Wells GA, Suarez-Almazor ME, Buchbinder R, Lopez-Olivo MA, Ghogomu ET, Tugwell P. A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview. CMAJ 2009, 181:787-796.
22. Nixon RM, Bansback N, Brennan A. Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis. Stat Med 2007, 26:1237-1254.
23. Jadad A, Moore A, Carroll D, Jenikson C, Reynols J, Gavaghan D, McQuay H. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996, 17:1-12.
24. Wells G, Li T, Maxwell L, MacLean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol 2007, 34:280-289.
25. Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 1993, 20:557-560.
26. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158.
27. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008, 9:105-121.
28. Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982, 9:789-793.
29. Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, Lee K, Boersma C, Annemans L, Cappelleri JC. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health 2011, 14:417-428.
30. Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med 2004, 23:3105-3124.
31. Caldwell DM, Ades AE, Higgins JP. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005, 331:897-900.
32. Hoaglin DC, Hawkins N, Jansen JP, Scott DA, Itzler R, Cappelleri JC, Boersma C, Thompson D, Larholt KM, Diaz M, Barrett A. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2. Value Health 2011, 14:429-437.
33. Sutton AJ, Abrams KR. Bayesian methods in meta-analysis and evidence synthesis. Stat Methods Med Res 2001, 10:277-303.
34. Spiegelhalter DJ, Best NG, van der Carlin BP, Linde A. Bayesian measures of model complexity and fit. J R Stat Soc 2002, 64:583-639.
35. Spiegelhalter D, Thomas A, Best N, Lunn D. WinBUGS User Manual: Version 1.4 2003, Cambridge: MRC Biostatistics Unit.
36. Cohen SB, Moreland LW, Cush JJ, Greenwald MW, Block S, Shergy WJ, Hanrahan PS, Kraishi MM, Patel A, Sun G, Bear MB, . 990145 Study Group A multicentre, double blind, randomised, placebo controlled trial of anakinra Kineret, a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis 2004, 63:1062-1068. 990145 Study Group.
37. Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, Pavelka K, Sambrook PN, Smolen JS, Khandker R, Singh A, Wajdula J, Fatenejad S, . Etanercept European Investigators Network Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study. Ann Rheum Dis 2009, 68:1146-1152. Etanercept European Investigators Network.
38. Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, Pavelka K, Sambrook PN, Smolen JS, Wajdula J, Fatenejad S, . Etanercept European Investigators Network (Etanercept Study 309 Investigators) Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double- blind comparison. Ann Rheum Dis 2006, 65:1357-1362. Etanercept European Investigators Network (Etanercept Study 309 Investigators).
39. Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: The FAST4WARD study. Ann Rheum Dis 2009, 68:805-811.
40. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease- modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008, 58:2968-2980.
41. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, Fischkoff SA, Chartash EK. Radiographic, clinical, and functional outcomes of treatment with adalimumab a human anti-tumor necrosis factor monoclonal antibody in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004, 50:1400-1411.
42. Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, Pazdur J, Bae SC, Palmer W, Zrubek J, Wiekowski M, Visvanathan S, Wu Z, Rahman MU, . GO-FORWARD Study Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009, 68:789-796. GO-FORWARD Study.
43. Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006, 144:865-876.
44. Kremer J, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S, Russell A, Dougados M, Emery P, Nuamah IF, Williams GR, Becker JC, Hagerty DT, Moreland LW. Treatment of Rheumatoid Arthritis by Selective Inhibition of T-Cell Activation with Fusion Protein CTLA4Ig. New Engl J Med 2003, 349:1907-1915.
45. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN, . Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000, 343(22):1594-1602. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.
46. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, Smolen J, Emery P, Harriman G, Feldmann M, Lipsky P. Infliximab chimeric anti-tumour necrosis factor alpha monoclonal antibody versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial ATTRACT Study Group. Lancet 1999, 354:1932-1939.
47. Russell AS, Wallenstein GV, Li T, Martin MC, Maclean R, Blaisdell B, Gajria K, Cole JC, Becker JC, Emery P. Abatacept improves both the physical and mental health of patients with rheumatoid arthritis who have inadequate response to methotrexate treatment. Ann Rheum Dis 2007, 66(2):189-194.
48. Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 2008, 67:1096-1103.
49. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R, . OPTION Investigators Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet 2008, 371:987-997. OPTION Investigators.
50. Smolen J, Landewé RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study A randomised controlled trial. Ann Rheum Dis 2009, 68:797-804.
51. Strand V, Mease P, Burmester GR, Nikaï E, Coteur G, van Vollenhoven R, Combe B, Keystone EC, Kavanaugh A. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial. Arthritis Res Ther 2009, 11(6):R170.
52. Strand V, Smolen JS, van Vollenhoven RF, Mease P, Burmester GR, Hiepe F, Khanna D, Nikaï E, Coteur G, Schiff M. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis 2011, 70(6):996-1002.
53. Van der Heijde D, Klareskog L, Singh A, Tornero J, Melo-Gomes J, Codreanu C, Pedersen R, Freundlich B, Fatenejad S. Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial. Ann Rheum Dis 2006, 65(3):328-334.
54. Weinblatt M, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, Teoh LA, Fischkoff SA, Chartash EK. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003, 48:35-45.
55. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, Jackson CG, Lange M, Burge DJ. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999, 340:253-259.
56. Yount S, Sorensen MV, Cella D, Sengupta N, Grober J, Chartash EK. Adalimumab plus methotrexate or standard therapy is more effective than methotrexate or standard therapies alone in the treatment of fatigue in patients with active, inadequately treated rheumatoid arthritis. Clin Exp Rheumatol 2007, 25(6):838-846.
57. Tugwell P, Wells G, Strand V, Maetzel A, Bombardier C, Crawford B, Dorrier C, Thompson A. Clinical improvement as reflected in measures of function and health-related quality of life following treatment with leflunomide compared with methotrexate in patients with rheumatoid arthritis: sensitivity and relative efficiency to detect a treatment effect in a twelve-month, placebo-controlled trial. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum 2000, 43:506-514.
58. Pincus T, Strand V, Koch G, Amara I, Crawford B, Wolfe F, Cohen S, Felson D. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003, 48:625-630.
59. Strand V, Cohen S, Crawford B, Smolen JS, Scott DL. Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. Rheumatology (Oxford) 2004, 43:640-647.
60. Wolfe F, Hawley DJ, Wilson K. The prevalence and meaning of fatigue in rheumatic disease. J Rheumatol 1996, 23:1407-1417.
61. Belza BL, Henke CJ, Yelin EH, Epstein WV, Gilliss CL. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res 1993, 42:93-99.
62. Pollard LC, Choy EH, Gonzalez J, Khoshaba B, Scott DL. Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology (Oxford) 2006, 45:885-889.