Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial

Clinical and Experimental Rheumatology

Volumn 34, Issue 4, 2016, Pages 625-633

  Kremer, Joel M ^a   Blanco, Ricardo ^b   Halland, Anne Marie ^c   Brzosko, Marek ^d   Burgos Vargas, Ruben ^e   Mela, Christopher M ^f   Rowell, Lucy ^f   Fleischmann, Roy M ^g  

^a ALBANY MEDICAL COLLEGE   (United States)

^b HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^c Panorama Medi Clinic   (South Africa)

^d POMERANIAN MEDICAL UNIVERSITY   (Poland)

^e UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO   (Mexico)

^f ROCHE PRODUCTS LTD   (United Kingdom)

^g METROPLEX CLINICAL RESEARCH CENTER   (United States)

Author keywords

Biological therapy; Radiography; Rheumatoid arthritis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; METHOTREXATE; PLACEBO; TOCILIZUMAB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ANAPHYLAXIS; ANEMIA; ARTICLE; ATYPICAL MYCOBACTERIOSIS; BLEEDING; BRAIN ARTERY ANEURYSM; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; BREAST CANCER; BRONCHITIS; CELLULITIS; COCCIDIOIDOMYCOSIS; CONTROLLED STUDY; DAS28; DIGESTIVE SYSTEM PERFORATION; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EMPYEMA; ENDOCRINE DISEASE; ERYTHROCYTE SEDIMENTATION RATE; ESOPHAGUS CANDIDIASIS; EYE DISEASE; FAINTNESS; FEMALE; GASTROINTESTINAL CANDIDIASIS; GASTROINTESTINAL DISEASE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL INFECTION; GENANT MODIFIED TOTAL SHARP SCORE; GENITAL HERPES; GENITAL SYSTEM DISEASE; HEART DISEASE; HEART INFARCTION; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HUMAN; HYPERTRANSAMINASEMIA; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INFUSION RELATED REACTION; INJURY; INTOXICATION; INVASIVE CANDIDIASIS; JOINT RADIOGRAPHY; KIDNEY DISEASE; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MOUTH ULCER; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL DISEASE ASSESSMENT; MYCOBACTERIOSIS; MYCOSIS; NEOPLASM; NEUROLOGIC DISEASE; NEUTROPENIA; NON MELANOMA SKIN CANCER; NUTRITIONAL DISORDER; OPEN STUDY; OPPORTUNISTIC INFECTION; OSTEOMYELITIS; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROSTATE CANCER; PULMONARY CRYPTOCOCCOSIS; RANDOMIZED CONTROLLED TRIAL; REMISSION; RESPIRATORY TRACT DISEASE; RHEUMATOID ARTHRITIS; SALPINGITIS; SIDE EFFECT; SKIN DISEASE; SQUAMOUS CELL CARCINOMA; SUBARACHNOID HEMORRHAGE; THORAX DISEASE; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TRANSIENT ISCHEMIC ATTACK; TUBOOVARIAN ABSCESS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT DISEASE; URINARY TRACT INFECTION; VASCULAR DISEASE; ARTHRITIS, RHEUMATOID; ARTHROGRAPHY; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DISABILITY; DRUG EFFECTS; JOINT; MIDDLE AGED; PATHOLOGY; RADIOGRAPHY; TIME FACTOR; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; ARTHROGRAPHY; BLOOD SEDIMENTATION; DISABILITY EVALUATION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; JOINTS; MALE; METHOTREXATE; MIDDLE AGED; REMISSION INDUCTION; TIME FACTORS; TREATMENT OUTCOME;

EID: 84984856885     PISSN: 0392856X     EISSN: 1593098X     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. DAYER JM, CHOY E: Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology 2010; 49: 15-24.
2. ASSIER E, BOISSIER MC, DAYER JM: Interleukin-6: from identification of the cytokine to development of targeted treatments. Joint Bone Spine 2010; 77: 532-36.
3. HASHIZUME M, MIHARA M: The roles of interleukin-6 in the pathogenesis of rheumatoid arthritis. Arthritis 2011; 2011: 765624.
4. HOUSSIAU FA, DEVOGELAER JP, van DAMME J, de DEUXCHAISNES CN, van SNICK J: Interleukin-6 in synovial fluid and serum of patients with rheumatoid arthritis and other inflammatory arthritides. Arthritis Rheum 1988; 31: 784-8.
5. GOTTENBERG JE, DAYER JM, LUKAS C et al.: Serum IL-6 and IL-21 are associated with markers of B cell activation and structural progression in early rheumatoid arthritis: results from the ESPOIR cohort. Ann Rheum Dis 2012; 71: 1243-8.
6. MIHARA M, KASUTANI K, OKAZAKI M et al.: Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int Immunopharmacol 2005; 5: 1731-40.
7. EMERY P, KEYSTONE E, TONY HP et al.: 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. Ann Rheum Dis 2008; 67: 1516-23.
8. NISHIMOTO N, TERAO K, MIMA T, NAKAHARA H, TAKAGI N, KAKEHI T: Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman disease. Blood 2008; 112: 3959-64.
9. 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.
10. SMOLEN JS, BEAULIEU A, RUBBERT-ROTH A et al.; and OPTION Investi gato rs: Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebocontrolled, randomised trial. Lancet 2008; 371: 987-97.
11. 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.
12. NISHIMOTO N, MIYASAKA N, YAMAMOTO K et al.: Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol 2009; 19: 12-9.
13. KREMER JM, BLANCO R, BRZOSKO S et al.: Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum 2011; 63: 609-21.
14. FLEISCHMANN RM, HALLAND AM, BRZOSKO M et al.: Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol 2013; 40: 113-26.
15. NISHIMOTO N, HASHIMOTO J, MIYASAKA N et al.: Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis 2007; 66: 1162-7.
16. BURMESTER GR, FEIST E, KELLNER H, BRAUN J, IKING-KONERT C, RUBBERT-ROTH A: Effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 weeks in patients with active rheumatoid arthritis: the first phase IIIb real-life study (TAMARA). Ann Rheum Dis 2011; 70: 755-9.
17. BYKERK V, OSTOR AJK, ALVARO-GRACIA J et al.: Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Ann Rheum Dis 2012; 71: 1950-4.
18. FELSON DT, SMOLEN JS, WELLS G et al.: American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis 2011; 70: 404-13
19. KREMER J, FURST D, BURGOS-VARGAS R et al.: LITHE: tocilizumab (TCZ) inhibits radiographic progression, maintains clinical efficacy in rheumatoid arthritis (RA) patients (PTS) at 3 years [abstract]. Ann Rheum Dis 2011; 70: 467.
20. ALETAHA D, FUNOVITS J, SMOLEN JS: Physical disability in rheumatoid arthritis is associated with cartilage damage rather than bone destruction. Ann Rheum Dis 2011; 70: 733-9.
21. van der HEIJDE D, BREEDVELD FC, KAVANAUGH A et al.: Disease activity, physical function, and radiographic progression after longterm therapy with adalimumab plus methotrexate: 5-year results of PREMIER. J Rheumatol 2010; 37: 2237-46.
22. KREMER JM, PETERFY C, RUSSELL AS et al.: Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial. J Rheumatol 2014; 41: 1077-87.
23. van HERWAARDEN N, HERFKENS-HOL S, van der MAAS A et al.: Dose reduction of tocilizumab in rheumatoid arthritis patients with low disease activity. Clin Exp Rheumatol 2014; 32: 390-94.
24. ADDIMANDA O, POSSEMATO N, MACCHIONI P, SALVARANI C: Efficacy and safety of tocilizumab in refractory rheumatoid arthritis: a real life cohort from a single centre. Clin Exp Rheumatol 2014; 32: 460-64.
25. SMOLEN JS, LANDEWé R, BREEDVELD FC et al.: EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014; 73: 492-509.