Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: The HIKARI randomized, placebo-controlled trial

Modern Rheumatology

Volumn 24, Issue 4, 2014, Pages 552-560

  Yamamoto, Kazuhiko ^a   Takeuchi, Tsutomu ^b   Yamanaka, Hisashi ^c   Ishiguro, Naoki ^d   Tanaka, Yoshiya ^e   Eguchi, Katsumi ^f   Watanabe, Akira ^g   Origasa, Hideki ^h   Iwai, Koichi ⁱ   Sakamaki, Yoshiharu ^j   Van Der Heijde, Désirée ^k   Miyasaka, Nobuyuki ^l   Koike, Takao ^m  

^a UNIVERSITY OF TOKYO   (Japan)

^b KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^d NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^f Sasebo Shiritsu Sogo Hospital   (Japan)

^g TOHOKU UNIVERSITY   (Japan)

^h UNIVERSITY OF TOYAMA   (Japan)

ⁱ OTSUKA PHARMACEUTICAL CO LTD   (Japan)

^j UCB PHARMA   (Belgium)

^k LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^l TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^m HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

more..

Author keywords

Certolizumab pegol; Monotherapy; Randomized controlled trial; Rheumatoid arthritis; Tumor necrosis factor alpha inhibitor

Indexed keywords

ACTARIT; AURANOFIN; AUROTHIOMALATE; BUCILLAMINE; CERTOLIZUMAB PEGOL; CORTICOSTEROID; DISEASE MODIFYING ANTIRHEUMATIC DRUG; METHOTREXATE; MIZORIBINE; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PNEUMOCOCCUS VACCINE; SALAZOSULFAPYRIDINE; SODIUM CHLORIDE; TACROLIMUS; ANTIRHEUMATIC AGENT; IMMUNOGLOBULIN F(AB) FRAGMENT; MACROGOL DERIVATIVE; MONOCLONAL ANTIBODY;

ADULT; AGED; AORTA DISSECTING ANEURYSM; ARTICLE; BACTERIAL ARTHRITIS; CONSTIPATION; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ECZEMA; FEMALE; FOOT RADIOGRAPHY; HAND RADIOGRAPHY; HEMATOMA; HERPES ZOSTER; HUMAN; HYPERTENSION; INCIDENCE; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; PHARYNGITIS; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; STREPTOCOCCUS PNEUMONIA; UPPER RESPIRATORY TRACT INFECTION; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; JAPAN; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; JAPAN; MALE; METHOTREXATE; MIDDLE AGED; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84897972127     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2013.843764     Document Type: Article

References (28)

1. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999;354(9194):1932-9.
2. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340(4):253-9.
3. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48(1):35-45.
4. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004;50(4):1051-65.
5. Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009;68(6):797-804.
6. Keystone E, Heijde D, Mason D Jr., Landewé R, Vollenhoven RV, Combe B, et al. Certolizumab pegol plus methotrexate is significantly more Effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58(11):3319-29.
7. Emery P, Fleischmann R, van der Heijde D, Keystone EC, Genovese MC, Conaghan PG, et al. The Effects of golimumab on radiographic progression in rheumatoid arthritis: results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy. Arthritis Rheum.2011;63(5):1200-10.
8. Takeuchi T. Revolutionary change in rheumatoid arthritis management with biological therapy. Keio J Med. 2011;60(3):75-81.
9. Salliot C, van der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis. 2009;68(7):1100-4.
10. Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009;68(6):805-11.
11. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al.; American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727-35.
12. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31(3):315-24.
13. van Gestel AM, Prevoo ML, van't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39(1):34-40.
14. van der Heijde D, Simon L, Smolen J, Strand V, Sharp J, Boers M, et al. How to report radiographic data in randomized clinical trials in rheumatoid arthritis: guidelines from a roundtable discussion. Arthritis Rheum. 2002;47(2):215-8.
15. van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol. 2000;27(1):261-3.
16. Ware JE, Kosinski M. SF-36 Physical and Mental Health Summary Scales: manual for users version 1. 2nd ed. Rhode Island, USA: Quality Metric; 2001.
17. Methotrexate Prescribing Information. Available from: http://www. accessdata.fda.gov/drugsatfda-docs/label/2011/011719s117lbl.pdf. 2011. [Accessed 7 March 2013].
18. Methotrexate Package Insert. Available from:http://www.info.pmda. go.jp/downfiles/ph/PDF/671450-3999016M1021-2-10.pdf. 2011. [Accessed 7 March 2013].
19. Kameda H, Ueki Y, Saito K, Nagaoka S, Hidaka T, Atsumi T, et al. Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial. Mod Rheumatol. 2010; 20(6): 531-8.
20. Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic Effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet. 2004;363(9410):675-81.
21. Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272-83.
22. Miyasaka N, CHANGE Study Investigators. Clinical investigation in highly disease-aff ected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol. 2008;18(3):252-62.
23. RamiroS, van Tubergen AM, Landewé RB. RAPID and FAST4WARD trials: certolizumab pegol for rheumatoid arthritis. Expert Rev Clin Immunol. 2010;6(5):713-20.
24. van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis. 2004;63(5):508-16.
25. Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013;72(9): 1488-95.
26. Koike R, Takeuchi T, Eguchi K, Miyasaka N, Japan College of Rheumatology. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007;17(6):451-8.
27. Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67(2):189-94.
28. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and Effectiveness of etanercept in Japan. J Rheumatol. 2009; 36(5): 898-906.