Reporting of long-term extension studies: Lack of consistency calls for consensus

Annals of the Rheumatic Diseases

Volumn 70, Issue 6, 2011, Pages 886-890

  Buch, Maya H ^a,b   Aletaha, Daniel ^c   Emery, Paul ^a,b   Smolen, Josef S ^c,d  

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d HIETZING HOSPITAL   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; ETANERCEPT; LEFLUNOMIDE; METHOTREXATE; PLACEBO; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; TOCILIZUMAB;

CLINICAL STUDY; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; INFECTION; INTENTION TO TREAT ANALYSIS; LONG TERM EXTENSION STUDY; MALIGNANT NEOPLASTIC DISEASE; MEDICAL ETHICS; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RELIABILITY; REVIEW; RHEUMATOID ARTHRITIS; UNSPECIFIED SIDE EFFECT;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CONSENSUS; ETHICS, RESEARCH; FOLLOW-UP STUDIES; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 79955839705     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/ard.2010.143420     Document Type: Review

References (30)

1. US Food and Drug Administration. www.fda.gov (accessed Oct 2010).
2. European Medicines Agency. www.emea.europa.eu (accessed Oct 2010).
3. Moreland L W, Baumgartner SW, Schiff MH, et al. T reatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med 1997 ; 337 : 141-7. (Pubitemid 27306284) (Pubitemid 27306284)
4. Maini R, St Clair EW, Breedveld F, et al. 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 : 1932-9.
5. Weinblatt M E, Keystone EC, Furst DE, et al. 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. (Pubitemid 36091645) (Pubitemid 36091645)
6. Cohen S B, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006 ; 54 : 2793-806. (Pubitemid 44497758) (Pubitemid 44497758)
7. Genovese M C, Becker JC, Schiff M, et al. A batacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005 ; 353 : 1114-23. (Pubitemid 41317434) (Pubitemid 41317434)
8. Emery P, Keystone E, Tony HP, et al. I L-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebocontrolled trial. Ann Rheum Dis 2008 ; 67 : 1516-23.
9. G enovese M C, Schiff M, Luggen M, et al. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis 2008 ; 67 : 547-54. (Pubitemid 351498439) (Pubitemid 351498439)
10. Strand V, Balbir-Gurman A, Pavelka K, et al. Sustained benefit in rheumatoid arthritis following one course of rituximab: improvements in physical function over 2 years. Rheumatology (Oxford) 2006 ; 45 : 1505-13. (Pubitemid 44817056) (Pubitemid 44817056)
11. Keystone E, Fleischmann R, Emery P, et al. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum 2007 ; 56 : 3896-908. (Pubitemid 350262316) (Pubitemid 350262316)
12. N uki G, Bresnihan B, Bear MB, et al. Long-term safety and maintenance of clinical improvement following treatment with anakinra (recombinant human interleukin-1 receptor antagonist) in patients with rheumatoid arthritis: extension phase of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002 ; 46 : 2838-46. (Pubitemid 35315874) (Pubitemid 35315874)
13. Kremer JM, Weinblatt ME, Bankhurst AD, et al. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations. Arthritis Rheum 2003 ; 48 : 1493-9. (Pubitemid 36682355) (Pubitemid 36682355)
14. Moreland LW, Weinblatt ME, Keystone EC, et al. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol 2006 ; 33 : 854-61.
15. Smolen JS, Gomez-Reino JJ, Vernon E, et al. Efficacy of tocilizumab in patients with RA and inadequate response to DMARDs or TNF inhibitors: up to 3.5-year data from ongoing extension studies (abstract). Ann Rheum Dis 2010 ; 69(Suppl 3) : 542.
16. Jones G, Sebba A, Calvo A, et al. Efficacy of tocilizumab in patients with rheumatoid arthritis who had never been exposed to or had never failed methotrexate: analysis of up to 3 years of treatment in a long-term extension study (abstract). Ann Rheum Dis 2010 ; 69(Suppl3) : 386.
17. Kalden JR, Schattenkirchner M, Sörensen H, et al. The efficacy and safety of leflunomide in patients with active rheumatoid arthritis: a five-year followup study. Arthritis Rheum 2003 ; 48 : 1513-20. (Pubitemid 36682358) (Pubitemid 36682358)
18. Kremer JM, Genant HK, Moreland LW, et al. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum 2008 ; 58 : 953-63. (Pubitemid 351563996) (Pubitemid 351563996)
19. Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010 ; 69 : 631-7.
20. A letaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis 2008 ; 67 : 1360-4.
21. Dixon WG, Carmona L, Finckh A, et al. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis 2010 ; 69 : 1596-602.
22. Hochberg MC, Tracy JK, Hawkins-Holt M, et al. Comparison of the efficacy of the tumour necrosis factor alpha blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis 2003 ; 62(Suppl 2) : ii13-16.
23. Bresnihan B, Alvaro-Gracia JM, Cobby M, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998 ; 41 : 2196-204. (Pubitemid 29009378) (Pubitemid 29009378)
24. Weinblatt ME, Kremer JM, Bankhurst AD, et al. 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 : 253-9. (Pubitemid 29063266) (Pubitemid 29063266)
25. Weinblatt ME, Keystone EC, Furst DE, et al. Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study. Ann Rheum Dis 2006 ; 65 : 753-9. (Pubitemid 43799174) (Pubitemid 43799174)
26. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis 2009 ; 68 : 1580-4.
27. Smolen JS, Beaulieu A, Rubbert-Roth A, et al. 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 : 987-97. (Pubitemid 351392039) (Pubitemid 351392039)
28. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 2010 ; 69 : 88-96.
29. Genovese MC, McKay JD, Nasonov EL, et al. 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 : 2968-80.
30. Van Vollenhoven RF, Scali JJ, Curtis JR, et al. Safety of tocilizumab in patients with rheumatoid arthritis: analysis of median of 3.1 years of treatment in long-term extension studies. Ann Rheum Dis 2010 ; 69(Suppl 3) : 544.