Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

被引:108
作者
Coombs, J. H. [1 ]
Bloom, B. J. [2 ]
Breedveld, F. C. [3 ]
Fletcher, M. P. [1 ]
Gruben, D. [2 ]
Kremer, J. M. [4 ]
Burgos-Vargas, R. [5 ]
Wilkinson, B. [2 ]
Zerbini, C. A. F. [6 ]
Zwillich, S. H. [1 ]
机构
[1] Pfizer Inc, Ann Arbor, MI USA
[2] Pfizer Inc, New London, CT USA
[3] Leiden Univ, Med Ctr, Leiden, Netherlands
[4] Albany Med Coll, Albany, NY 12208 USA
[5] Hosp Gen Mexico City, Mexico City, DF, Mexico
[6] Hosp Heliopolis, Sao Paulo, Brazil
关键词
QUALITY-OF-LIFE; COMBINATION THERAPY; MONOCLONAL-ANTIBODY; REPORTED OUTCOMES; METHOTREXATE; ETANERCEPT; ADALIMUMAB; EFFICACY; SAFETY;
D O I
10.1136/ard.2009.108159
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives: To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor a inhibitor. Methods: Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks' follow-up. The patient's assessment of arthritis pain (pain), patient's assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded. Results: At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (>= 0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components. Conclusions: CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.
引用
收藏
页码:413 / 416
页数:4
相关论文
共 16 条
  • [1] The PREMIER study - A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment
    Breedveld, FC
    Weisman, MH
    Kavanaugh, AF
    Cohen, SB
    Pavelka, K
    van Vollenhoven, R
    Sharp, J
    Perez, JL
    Spencer-Green, GT
    [J]. ARTHRITIS AND RHEUMATISM, 2006, 54 (01): : 26 - 37
  • [2] Work disability in an inception cohort of patients with seropositive rheumatoid arthritis:: a 20 year study
    Jäntti, J
    Aho, K
    Kaarela, K
    Kautiainen, H
    [J]. RHEUMATOLOGY, 1999, 38 (11) : 1138 - 1141
  • [3] 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
    Keystone, EC
    Kavanaugh, AF
    Sharp, JT
    Tannenbaum, H
    Hua, Y
    Teoh, LS
    Fischkoff, SA
    Chartash, EK
    [J]. ARTHRITIS AND RHEUMATISM, 2004, 50 (05): : 1400 - 1411
  • [4] Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial
    Klareskog, L
    van der Heijde, D
    de Jager, JP
    Gough, A
    Kalden, J
    Malaise, M
    Mola, EM
    Pavelka, K
    Sany, J
    Settas, L
    Wajdula, J
    Pedersen, R
    Fatenejad, S
    Sanda, M
    [J]. LANCET, 2004, 363 (9410) : 675 - 681
  • [5] The Safety and Efficacy of a JAK Inhibitor in Patients With Active Rheumatoid Arthritis Results of a Double-Blind, Placebo-Controlled Phase IIa Trial of Three Dosage Levels of CP-690,550 Versus Placebo
    Kremer, Joel M.
    Bloom, Bradley J.
    Breedveld, Ferdinand C.
    Coombs, John H.
    Fletcher, Mark P.
    Gruben, David
    Krishnaswami, Sriram
    Burgos-Vargas, Ruben
    Wilkinson, Bethanie
    Zerbini, Cristiano A. F.
    Zwillich, Samuel H.
    [J]. ARTHRITIS AND RHEUMATISM, 2009, 60 (07): : 1895 - 1905
  • [6] Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate
    Maini, RN
    Breedveld, FC
    Kalden, JR
    Smolen, JS
    Furst, D
    Weisman, MH
    St Clair, EW
    Keenan, GF
    van der Heijde, D
    Marsters, PA
    Lipsky, PE
    [J]. ARTHRITIS AND RHEUMATISM, 2004, 50 (04): : 1051 - 1065
  • [7] Singh G., 1996, Arthritis and Rheumatism, V39, pS318
  • [8] Strand V, 2005, J RHEUMATOL, V32, P590
  • [9] Efficacy and safety of the fully human anti-tumour necrosis factor α monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis:: a 12 week, phase II study
    van de Putte, LBA
    Rau, R
    Breedveld, FC
    Kalden, JR
    Malaise, MG
    van Riel, PLCM
    Schattenkirchner, M
    Emery, P
    Burmester, GR
    Zeidler, H
    Moutsopoulos, HM
    Beck, K
    Kupper, H
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2003, 62 (12) : 1168 - 1177
  • [10] Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial
    van der Heijde, D
    Klareskog, L
    Singh, A
    Tornero, J
    Melo-Gomes, J
    Codreanu, C
    Pedersen, R
    Freundlich, B
    Fatenejad, S
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2006, 65 (03) : 328 - 334