Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study

Modern Rheumatology

Volumn 24, Issue 1, 2014, Pages 26-32

  Nishimoto, Norihiro ^a,b,c   Amano, Koichi ^d   Hirabayashi, Yasuhiko ^e   Horiuchi, Takahiko ^f   Ishii, Tomonori ^g   Iwahashi, Mitsuhiro ^h   Iwamoto, Masahiro ⁱ   Kohsaka, Hitoshi ^j   Kondo, Masakazu ^k   Matsubara, Tsukasa ^l   Mimura, Toshihide ^d   Miyahara, Hisaaki ^m   Ohta, Shuji ⁿ   Saeki, Yukihiko ^o   Saito, Kazuyoshi ^p   Sano, Hajime ^q   Takasugi, Kiyoshi ^r   Takeuchi, Tsutomu ^s   Tohma, Shigeto ^t   Tsuru, Tomomi ^u   Ueki, Yukitaka ^v   Yamana, Jiro ^h   Hashimoto, Jun ^o   Matsutani, Takaji ^c   Murakami, Miho ^b,c   Takagi, Nobuhiro ^w   more..

^a Osaka Rheumatology Clinic   (Japan)

^b TOKYO MEDICAL UNIVERSITY   (Japan)

^c WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^d SAITAMA MEDICAL UNIVERSITY   (Japan)

^e Hikarigaoka Spellman Hospital   (Japan)

^f KYUSHU UNIVERSITY   (Japan)

^g TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^h Higashihiroshima Memorial Hospital   (Japan)

ⁱ JICHI MEDICAL UNIVERSITY   (Japan)

^j TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^k Kondo Clinic of Rheumatology and Orthopaedic Surgery   (Japan)

^l Matsubara Mayflower Hospital   (Japan)

^m NATIONAL HOSPITAL ORGANIZATION KYUSHU MEDICAL CENTER   (Japan)

ⁿ Taga General Hospital   (Japan)

^o MINAMI OSAKA GENERAL HOSPITAL   (Japan)

^p UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^q HYOGO COLLEGE OF MEDICINE   (Japan)

^r Dohgo Spa Hospital   (Japan)

^s KEIO UNIVERSITY   (Japan)

^t NATIONAL HOSPITAL ORGANIZATION   (Japan)

^u PS Clinic   (Japan)

^v SASEBO CHUO HOSPITAL   (Japan)

^w CHUGAI PHARMACEUTICAL CO LTD   (Japan)

more..

Author keywords

Drug free; Interleukin 6; Retreatment; Rheumatoid arthritis; Tocilizumab

Indexed keywords

CORTICOSTEROID; DISEASE MODIFYING ANTIRHEUMATIC DRUG; INFLIXIMAB; METHOTREXATE; SALAZOSULFAPYRIDINE; TACROLIMUS; TOCILIZUMAB;

ADULT; AGED; ARTICLE; BENIGN TUMOR; BREAST DISEASE; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAS28; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; EAR DISEASE; EYE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; HEART DISEASE; HEMATOLOGIC DISEASE; HUMAN; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INFUSION RELATED REACTION; INNER EAR DISEASE; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; REPRODUCTIVE TOXICITY; RESPIRATORY TRACT DISEASE; RETREATMENT; RHEUMATOID ARTHRITIS; THORAX DISEASE; TREATMENT OUTCOME; VASCULAR DISEASE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; RECURRENCE; RETREATMENT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84904987888     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2013.854080     Document Type: Article

References (20)

1. Choy EH, Isenberg DA, Garrood T, et al. Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin 6 receptor monoclonal antibody in rheumatoid arthritis: a randomized, double-blind, placebo-controlled, dose-escalation trial. Arthr Rheum. 2002;46:3143-50.
2. Nishimoto N, Yoshizaki K, Maeda K, et al. Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study. J Rheumatol. 2003;30: 1426-35.
3. Nishimoto N, Yoshizaki K, Miyasaka N, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthr Rheum. 2004;50:1761-9.
4. Maini RN, Taylor PC, Szechinski J, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthr Rheum. 2006;54:2817-29.
5. 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.
6. 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, placebocontrolled, randomised trial. Lancet. 2008;371:987-97.
7. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to diseasemodifying antirheumatic drugs: tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthr Rheum. 2008;58:2968-80.
8. 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.
9. Nishimoto N, Miyasaka N, Yamamoto K, et al. Relationship between serum IL-6 levels after tocilizumab treatment and clinical remission in active rheumatoid arthritis (RA) patients [abstract]. Ann Rheum Dis. 2008;67(Suppl 2):90.
10. 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.
11. 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.
12. Kremer JM, Blanco R, Brzosko M, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the doubleblind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthr Rheum. 2011;63:609-21.
13. Nishimoto N, Amano K, Hirabayashi Y, et al. Drug free REmission/low disease activity after cessation of tocilizumab (Actemra) Monotherapy (DREAM) study. Mod Rheumatol. 2013. doi:10.1007/s10165-013-0894-z
14. Fransen J, Creemers MC, Van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43:1252-5.
15. 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.
16. Sagawa A. The efficacy and safety of reinstitution of tocilizumab in patients with relapsed active rheumatoid arthritis after longterm withdrawal of tocilizumab: retreatment of patients with rheumatoid arthritis with novel anti-IL-6 receptor antibody after a long-term interval following SAMURAI: the RONIN study. Mod Rheumatol. 2011;21:352-8. doi:10.1007/s10165-011-0419-6.
17. Takeuchi T, Tatsuki Y, Nogami Y, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189-94.
18. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69:964-75.
19. Tanaka Y, Takeuchi T, Mimori T, et al. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010;69:1286-91.
20. Ribbens C, Andre B, Jaspar JM, et al. Matrix metalloproteinase-3 serum levels are correlated with disease activity and predict clinical response in rheumatoid arthritis. J Rheumatol. 2000;27: 888-93.