Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis

被引:15
作者
Elmedany, Samah Hamdy [1 ]
Mohamed, Aly Elsayed [2 ]
Galil, Sahar Mahfouz Abdel [3 ,4 ]
机构
[1] Tanta Univ, Phys Med Rheumatol & Rehabil Dept, El Giesh St, Tanta 31111, Egypt
[2] Suez Canal Univ, Phys Med Rheumatol & Rehabil Dept, Ismailia, Egypt
[3] Zagazig Univ, Fac Med, Rheumatol & Rehabil Dept, Univ St, Zagazig 44519, Egypt
[4] Umm Al Qura Univ, Coll Med, Med Dept, El Abdia 21955, Makkah Province, Saudi Arabia
关键词
Abatacept; Adverse effects; Disease activity; Rheumatoid arthritis; Tocilizumab; NECROSIS FACTOR AGENTS; INADEQUATE RESPONSE; DOUBLE-BLIND; RECEPTOR INHIBITION; IL-6; RECEPTOR; METHOTREXATE; MONOTHERAPY; ETANERCEPT; TRIAL;
D O I
10.1007/s10067-019-04508-2
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesTo compare the efficacy and safety of tocilizumab with those of abatacept in patients with active rheumatoid arthritis not responding to anti-tumor necrosis factor therapy.MethodsA prospective, open-label study was carried out on adult females with moderate-to-severe rheumatoid arthritis. Patients were randomly assigned to receive either intravenous tocilizumab or abatacept treatment. History taking, clinical examination, and laboratory evaluation were done at baseline and during a 24-week period of follow-up. Disease activity was calculated using the DAS28-ESR score. The incidence of accompanying adverse events was evaluated and all statistical analyses were performed by InStat.ResultsOne hundred thirty-two patients were enrolled and classified randomly into the tocilizumab (n=68) and abatacept (n=64) groups. By week 24, the mean DAS28-ESR was significantly reduced in both groups (P<0.0001) in association with significant reductions in CRP, ESR, and HAQ scores. No significant difference in the incidence rate of adverse effects appeared between both study groups. However, there were marked declines in the hemoglobin levels (P=0.003) and neutrophil count (P=0.002) together with significant elevations in systolic blood pressure (P=0.002), liver enzymes (P=0.001), total cholesterol (P=0.001), and high-density lipoproteins (P=0.002) in the tocilizumab group compared with the abatacept group.ConclusionBoth intravenous abatacept and tocilizumab significantly decreased the disease activity and improved the physical function in rheumatoid arthritis patients who failed to respond to anti-tumor necrosis factor therapy. Although the efficacy of both drugs was similar, abatacept showed a more promising short-term safety profile since it was associated with less adverse effects and better laboratory outcomes.
引用
收藏
页码:2109 / 2117
页数:9
相关论文
共 33 条
[1]   2010 Rheumatoid Arthritis Classification Criteria An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative [J].
Aletaha, Daniel ;
Neogi, Tuhina ;
Silman, Alan J. ;
Funovits, Julia ;
Felson, David T. ;
Bingham, Clifton O., III ;
Birnbaum, Neal S. ;
Burmester, Gerd R. ;
Bykerk, Vivian P. ;
Cohen, Marc D. ;
Combe, Bernard ;
Costenbader, Karen H. ;
Dougados, Maxime ;
Emery, Paul ;
Ferraccioli, Gianfranco ;
Hazes, Johanna M. W. ;
Hobbs, Kathryn ;
Huizinga, Tom W. J. ;
Kavanaugh, Arthur ;
Kay, Jonathan ;
Kvien, Tore K. ;
Laing, Timothy ;
Mease, Philip ;
Menard, Henri A. ;
Moreland, Larry W. ;
Naden, Raymond L. ;
Pincus, Theodore ;
Smolen, Josef S. ;
Stanislawska-Biernat, Ewa ;
Symmons, Deborah ;
Tak, Paul P. ;
Upchurch, Katherine S. ;
Vencovsky, Jiri ;
Wolfe, Frederick ;
Hawker, Gillian .
ARTHRITIS AND RHEUMATISM, 2010, 62 (09) :2569-2581
[2]   CTLA41g: Bridging the basic immunology with clinical application [J].
Bluestone, JA ;
St Clair, EW ;
Turka, LA .
IMMUNITY, 2006, 24 (03) :233-238
[3]   Sequential use of biologic therapy in rheumatoid arthritis [J].
Buch, Maya H. .
CURRENT OPINION IN RHEUMATOLOGY, 2010, 22 (03) :321-329
[4]   Interpreting lipid levels in the context of high-grade inflammatory states with a focus on rheumatoid arthritis: a challenge to conventional cardiovascular risk actions [J].
Choy, E. ;
Sattar, N. .
ANNALS OF THE RHEUMATIC DISEASES, 2009, 68 (04) :460-469
[5]   A signal achievement in the treatment of arthritis [J].
Cron, RQ .
ARTHRITIS AND RHEUMATISM, 2005, 52 (08) :2229-2232
[6]   Comparison of Drug Retention Rates and Causes of Drug Discontinuation Between Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis [J].
Du Pan, Sophie Martin ;
Dehler, Silvia ;
Ciurea, Adrian ;
Ziswiler, Hans-Rudolf ;
Gabay, Cem ;
Finckh, Axel .
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH, 2009, 61 (05) :560-568
[7]   IL-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 placebo-controlled trial [J].
Emery, P. ;
Keystone, E. ;
Tony, H. P. ;
Cantagrel, A. ;
van Vollenhoven, R. ;
Sanchez, A. ;
Alecock, E. ;
Lee, J. ;
Kremer, J. .
ANNALS OF THE RHEUMATIC DISEASES, 2008, 67 (11) :1516-1523
[8]   Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial [J].
Emery, Paul ;
Breedveld, Ferdinand C. ;
Hall, Stephen ;
Durez, Patrick ;
Chang, David J. ;
Robertson, Deborah ;
Singh, Amitabh ;
Pedersen, Ronald D. ;
Koenig, Andrew S. ;
Freundlich, Bruce .
LANCET, 2008, 372 (9636) :375-382
[9]   Evidence for differential acquired drug resistance to anti-tumour necrosis factor agents in rheumatoid arthritis [J].
Finckh, A. ;
Simard, J. F. ;
Gabay, C. ;
Guerne, P. -A. .
ANNALS OF THE RHEUMATIC DISEASES, 2006, 65 (06) :746-752
[10]   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 [J].
Genovese, M. C. ;
Schiff, M. ;
Luggen, M. ;
Becker, J-C ;
Aranda, R. ;
Teng, J. ;
Li, T. ;
Schmidely, N. ;
Le Bars, M. ;
Dougados, M. .
ANNALS OF THE RHEUMATIC DISEASES, 2008, 67 (04) :547-554