Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis

Arthritis Care and Research

Volumn 67, Issue 10, 2015, Pages 1354-1362

  Ogata, Atsushi ^a,v   Atsumi, Tatsuya ^b   Fukuda, Takaaki ^c   Hirabayashi, Yasuhiko ^d   Inaba, Masaaki ^e   Ishiguro, Naoki ^f   Kai, Motokazu ^g   Kawabata, Daisuke ^h   Kida, Daihei ⁱ   Kohsaka, Hitoshi ^j   Matsumura, Ryutaro ^k   Minota, Seiji ^l   Mukai, Masaya ^m   Sumida, Takayuki ⁿ   Takasugi, Kiyoshi ^o   Tamaki, Shigenori ^p   Takeuchi, Tsutomu ^q   Ueda, Atsuhisa ^r   Yamamoto, Kazuhiko ^s   Yamanaka, Hisashi ^t   Yoshifuji, Hajime ^h   Nomura, Akira ^u   more..

^a OSAKA UNIVERSITY   (Japan)

^b HOKKAIDO UNIVERSITY   (Japan)

^c KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d Hikarigaoka Spellman Hospital   (Japan)

^e Osaka Prefecture University   (Japan)

^f NAGOYA UNIVERSITY   (Japan)

^g National Hospital Organization Mie Chuo Medical Center   (Japan)

^h KYOTO UNIVERSITY   (Japan)

ⁱ Nagoya Medical Centre   (Japan)

^j TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^k SAKURA NATIONAL HOSPITAL   (Japan)

^l JICHI MEDICAL UNIVERSITY   (Japan)

^m SAPPORO CITY GENERAL HOSPITAL   (Japan)

ⁿ UNIVERSITY OF TSUKUBA   (Japan)

^o Dogo Spa Hospital   (Japan)

^p Nagoya Mental Clinic   (Japan)

^q KEIO UNIVERSITY   (Japan)

^r YOKOHAMA CITY UNIVERSITY   (Japan)

^s UNIVERSITY OF TOKYO   (Japan)

^t TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^u Chugai Pharmaceutical Co L   (Japan)

^v OSAKA POLICE HOSPITAL   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; CORTICOSTEROID; CYCLIC CITRULLINATED PEPTIDE ANTIBODY; INTERLEUKIN 6; METHOTREXATE; RHEUMATOID FACTOR; TOCILIZUMAB; TUMOR NECROSIS FACTOR INHIBITOR; MONOCLONAL ANTIBODY;

ADULT; ARTHROPATHY; ARTICLE; BODY WEIGHT; CLINICAL DISEASE ACTIVITY INDEX; CONTROLLED STUDY; DAS28; DEEP VEIN THROMBOSIS; DISEASE DURATION; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; EMBOLISM; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; FOOT MALFORMATION; GASTROENTERITIS; HUMAN; INJECTION SITE REACTION; JOINT DESTRUCTION; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MYCOPLASMA PNEUMONIA; OPEN STUDY; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHEUMATOID ARTHRITIS; TREATMENT OUTCOME; UROLITHIASIS; VARICOSIS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; FOLLOW UP; INTRAVENOUS DRUG ADMINISTRATION; JAPAN; JOINT CHARACTERISTICS AND FUNCTIONS; MIDDLE AGED; PAIN MEASUREMENT; PATIENT SATISFACTION; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA; SUBCUTANEOUS DRUG ADMINISTRATION; TIME;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; JAPAN; MALE; MIDDLE AGED; PAIN MEASUREMENT; PATIENT SATISFACTION; RANGE OF MOTION, ARTICULAR; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84942094202     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22598     Document Type: Article

References (21)

1. Komatsu N, Okamoto K, Sawa S, Nakashima T, Oh-Hora M, Kodama T, et al., Pathogenic conversion of Foxp3 T cells into T17 cells in autoimmune arthritis. Nat Med 2014; 20: 62-8.
2. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, 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.
3. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, 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.
4. Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, 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.
5. Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, 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.
6. Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, 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.
7. Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, 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.
8. Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, 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.
9. Ogata A, Tanimura K, Sugimoto T, Inoue H, Urata Y, Matsubara T, et al., Phase 3 study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2014; 66: 344-54.
10. Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, et al., A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 2014; 73: 69-74.
11. Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, et al., Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2014; 66: 1653-61.
12. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al., The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum 1993; 36: 729-40.
13. Stubenrauch K, Wessels U, Birnboeck H, Ramirez F, Jahreis A, Schleypen J., Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunogenicity testing. Clin Ther 2010; 32: 1597-609.
14. 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.
15. Ogata A, Amano K, Dobashi H, Inoo M, Ishii T, Kasama T, et al., Longterm safety and efficacy of subcutaneous tocilizumab monotherapy: results from the 2-year open-label extension of the MUSASHI Study. J Rheumatol 2015; 42: 799-809.
16. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al., Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007; 66: 921-6.
17. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al., Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010; 69: 817-21.
18. Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, et al., The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007; 25: 40-6.
19. Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, et al., Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase IIIb ALLOW study). Ann Rheum Dis 2012; 71: 38-44.
20. Pers YM, Fortunet C, Constant E, Lambert J, Godfrin-Valnet M, De Jong A, et al., Predictors of response and remission in a large cohort of rheumatoid arthritis patients treated with tocilizumab in clinical practice. Rheumatology (Oxford) 2014; 53: 76-84.
21. Kaneko A, Kida D, Saito K, Tsukamoto M, Sato T., Clinical results for tocilizumab over one year in the clinical setting as assessed by CDAI (Clinical Disease Activity Index): CRP at week 12 and MMP-3 at week 24 are predictive factors for CDAI. Rheumatol Int 2012; 32: 3631-7.