Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of 7740 patients

Modern Rheumatology

Volumn 24, Issue 3, 2014, Pages 390-398

  Koike, Takao ^a   Harigai, Masayoshi ^b   Ishiguro, Naoki ^c   Inokuma, Shigeko ^d   Takei, Syuji ^e   Takeuchi, Tsutomu ^f   Yamanaka, Hisashi ^g   Haruna, Shigenori ^h   Ushida, Naoko ^h   Kawana, Katsuyoshi ^h   Tanaka, Yoshiya ⁱ  

^a NTT CORPORATION   (Japan)

^b TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^c NAGOYA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d JAPANESE RED CROSS MEDICAL CENTER   (Japan)

^e KAGOSHIMA UNIVERSITY   (Japan)

^f KEIO UNIVERSITY   (Japan)

^g TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^h ABBVIE INC   (United States)

ⁱ UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

Author keywords

Adalimumab; Effectiveness; Postmarketing surveillance; Rheumatoid arthritis; Safety

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; ISONIAZID; METHOTREXATE; PREDNISOLONE; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS; ANKYLOSING SPONDYLITIS; ARTICLE; ATYPICAL MYCOBACTERIOSIS; AUTOIMMUNE DISEASE; BACTERIAL PNEUMONIA; BEHCET DISEASE; BRONCHIOLITIS; BRONCHITIS; BRONCHOPNEUMONIA; CHEMOPROPHYLAXIS; CHLAMYDIASIS; CHRONIC SINUSITIS; COMORBIDITY; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DEMYELINATING DISEASE; DISEASE ACTIVITY; DISEASE DURATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; FOLLOW UP; HERPES ZOSTER; HUMAN; INFLUENZA; INJECTION SITE REACTION; INTERSTITIAL PNEUMONIA; JAPANESE (PEOPLE); JUVENILE RHEUMATOID ARTHRITIS; LUNG INFECTION; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MILIARY TUBERCULOSIS; MORNING STIFFNESS; MYCOPLASMA PNEUMONIA; MYCOSIS; PANCYTOPENIA; PERITONSILLAR ABSCESS; PHARYNGITIS; PLEURA EMPYEMA; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PSORIASIS; REACTIVE ARTHRITIS; RHEUMATIC POLYMYALGIA; RHEUMATOID ARTHRITIS; RHEUMATOID VASCULITIS; RHINITIS; RHINOPHARYNGITIS; SEPSIS; SINUSITIS; STREPTOCOCCUS PNEUMONIA; TONSILLITIS; TREATMENT OUTCOME; TREATMENT RESPONSE; TUBERCULOSIS; TUBERCULOUS PLEURISY; UPPER RESPIRATORY TRACT INFECTION; VISUAL ANALOG SCALE; WEGENER GRANULOMATOSIS; ADOLESCENT; ARTHRITIS, RHEUMATOID; ASIAN CONTINENTAL ANCESTRY GROUP; CLINICAL TRIAL; JAPAN; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; ASIAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; JAPAN; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84900435415     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2013.843760     Document Type: Article

References (43)

1. Smolen JS. Aletaha D. Koeller M. Weisman MH. Emery P. New therapies for treatment of rheumatoid arthritis. Lancet. 2007; 370(9602): 1861-74
2. Smolen J S Aletaha D. Redlich K. T he pathogenesis of rheumatoid arthritis: New insights from old clinical data?. Nat Rev Rheumatol. 2012; 8(4): 235-43
3. Singh JA. Christensen R. Wells GA. Suarez-Almazor ME Buchbinder R Lopez-Olivo MA. Biologics for rheumatoid arthritis: N overview of Cochrane reviews. Cochrane Database Syst Rev. 2009; (4): CD007848
4. Curtis J R Singh J A. U se of biologics in rheumatoid arthritis: Current and emerging paradigms of care. Clin Ther. 2011; 33(6): 679-707
5. Takeuchi T. Tatsuki Y. Nogami Y. Ishiguro N. Tanaka Y. Yamanaka H et al. Postmarketing surveillance of the safety profi le of infl iximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008; 67(2): 189-94
6. Koike T. Harigai M. Inokuma S. Inoue K. Ishiguro N. Ryu J. et al. Postmarketing surveillance of the safety and eff ectiveness of etanercept in Japan. J. Rheumatol. 2009; 36(5): 898-906
7. Koike T. Harigai M. Inokuma S. Ishiguro N. Ryu J. Takeuchi T. et al. Postmarketing surveillance of safety and eff ectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2011; 21(4): 343-51
8. Koike T. Harigai M. Inokuma S. Ishiguro N. Ryu J. Takeuchi T et al. Safety and eff ectiveness responses to etanercept for rheumatoid arthritis in Japan: Sub-Analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis. Rheumatol Int. 2012; 32(6): 1511-9
9. Koike R. Harigai M. Atsumi T. Amano K. Kawai S. Saito K. et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab a humanized anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis. Mod Rheumatol. 2009; 19(4): 351-7
10. Koike T. Harigai M. Inokuma S. Ishiguro N. Ryu J. Takeuchi T et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: Interim analysis of 3881 patients. Ann Rheum Dis. 2011; 70(12): 2148-51
11. Prevoo M L van Riel P L van t H of M A van Rijswijk M H van Leeuwen MA Kuper HH et al. Validity and reproducibility of self-Administered joint counts. Aprospective longitudinal followup study in patients with rheumatoid arthritis. Arthritis Rheum. 1995; 38(1): 44-8
12. Subcommittee on Development of Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis Japan College of Rheumatology. Japan College of Rheumatology 2011 Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis (in Japanese). Tokyo Japan: Yodosha; 2011
13. Seto Y. Tanaka E. Inoue E. Nakajima A. Taniguchi A. Momohara S et al. Studies of the effi cacy and safety of methotrexate at dosages over 8 mg/week using the IORRA cohort database. Mod Rheumatol. 2011; 21(6): 579-93
14. Sakai R. Komano Y. Tanaka M. Nanki T. Koike R. Nakajima A. et al. The REAL database reveals no signifi cant risk of serious infection During treatment with a methotrexate dose of more than 8 mg/week in patients with rheumatoid arthritis. Mod Rheumatol. 2011; 21(4): 444-8
15. Klareskog L. van Der Heijde D. d e Jager J P Gough A. Kalden J Malaise M et al. Therapeutic eff ect 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
16. Breedveld FC. Weisman MH. Kavanaugh AF. Cohen SB. Pavelka K van Vollenhoven R. et al. The PREMIER study: Multicenter randomized double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006; 54(1): 26-37
17. Koike R. Takeuchi T. Eguchi K. Miyasaka N. Update on the Japanese guidelines for the use of infl iximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007; 17(6): 451-8
18. Koike T. Harigai M. Ishiguro N. Inokuma S. Takei S. Takeuchi T et al. Safety and eff ectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of the fi rst 3000 patients. Mod Rheumatol. 2012; 22(4): 498-508
19. HUMIRA (adalimumab) [prescribing information]. Pharmaceuticals and medical devices agency Web site [In Japanese]. Available at: Http://www.info.pmda.go.jp/downfiles/ph/PDF/1001593999426G 1024115.pdf. Accessed 14 March 2013
20. Steinbrocker O. Traeger CH. Batterman RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949; 140(8): 659-62
21. International Conference on Harmonisation (ICH) Steering Committee. ICH Harmonised Tripartite Guideline. Clinical safety data management: Defi nitions and standards for expedited reporting. Pharmaceuticals and medical devices agency Web site. Available at: Http:// www.pmda.go.jp/ich/e/e2a95320e.pdf. Accessed 14 March 2013
22. v an Gestel A M Haagsma C J van Riel P L. Validation of rheumatoid arthritis improvement criteria that include simplifi ed joint counts. Arthritis Rheum. 1998; 41(10): 1845-50
23. Fransen J. Creemers M C Van Riel P L. Remission in rheumatoid arthritis: Greement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004; 43(10): 1252-5
24. Felson D T Smolen J S Wells G. Zhang B. van Tuyl L H Funovits J et al. American College of Rheumatology/European League Against Rheumatism provisional defi nition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011; 63(3): 573-86
25. Felson D T Smolen J S Wells G. Zhang B. van Tuyl L H Funovits J et al. American College of Rheumatology/European League Against Rheumatism provisional defi nition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis. 2011; 70(3): 404-13
26. 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
27. Schiff MH. Burmester GR. Kent JD. Pangan AL. Kupper H Fitzpatrick SB et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006; 65(7): 889-94
28. Burmester GR. Mease P. Dijkmans BA. Gordon K. Lovell D Panaccione R. et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated infl ammatory diseases. Ann Rheum Dis. 2009; 68(12): 1863-9
29. Bj ö rn å dal L. Baecklund E. Yin L. Granath F. Klareskog L. Ekbom A. Decreasing mortality in patients with rheumatoid arthritis: Results from a large population based cohort in Sweden 1964-95. J. Rheumatol. 2002; 29(5): 906-12
30. Gabriel S E Crowson C S Kremers H M Doran M F Turesson C OFallon WM et al. Survival in rheumatoid arthritis: Populationbased analysis of trends over 40 years. Arthritis Rheum. 2003; 48(1) : 54-8
31. Hakoda M. Oiwa H. Kasagi F. Masunari N. Yamada M. Suzuki G et al. Mortality of rheumatoid arthritis in Japan: Longitudinal cohort study. Ann Rheum Dis. 2005; 64(10): 1451-5
32. Sihvonen S. Korpela M. Laippala P. Mustonen J. Pasternack A. Death rates and causes of death in patients with rheumatoid arthritis: Population-based study. Scand J Rheumatol. 2004; 33(4): 221-7
33. Komano Y. Tanaka M. Nanki T. Koike R. Sakai R. Kameda H et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: Report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J. Rheumatol. 2011; 38(7): 1258-64
34. Tanaka M. Sakai R. Koike R. Komano Y. Nanki T. Sakai F et al. Pneumocystis jirovecii pneumonia associated with etanercept treatment in patients with rheumatoid arthritis: Retrospective review of 15 cases and analysis of risk factors. Mod Rheumatol. 2012; 22(6): 849-58
35. Greenberg J D Reed G. Kremer J M Tindall E. Kavanaugh A. Zheng C et al. Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis. 2010; 69(2): 380-6
36. v an Der Veen M J van Der Heide A. Kruize A A Bijlsma J W. Infection rate and use of antibiotics in patients with rheumatoid arthritis treated with methotrexate. Ann Rheum Dis. 1994; 53(4): 224-8
37. Bernatsky S. Hudson M. Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology. 2007; 46(7): 1157-60
38. Doran MF. Crowson CS. Pond GR. O Fallon WM. Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum. 2002; 46(9): 2294-300
39. Crowson C S Hoganson D D Fitz-Gibbon P D Matteson E L. Development and validation of a risk score for serious infection in patients with rheumatoid arthritis. Arthritis Rheum. 2012; 64(9): 2847-55
40. Smolen J S Aletaha D. Bijlsma J W Breedveld F C Boumpas D Burmester G et al. Treating rheumatoid arthritis to target: Recommendations of an international task force. Ann Rheum Dis. 2010; 69(4): 631-7
41. Virkki LM. Valleala H. Takakubo Y. Vuotila J. Relas H. Komulainen R et al. Outcomes of switching anti-TNF drugs in rheumatoid arthritis-A study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN). Clin Rheumatol. 2011; 30(11): 1447-54
42. Bombardieri S. Ruiz A A Fardellone P. Geusens P. McKenna F Unnebrink K. et al. Eff ectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-Antagonist therapy in clinical practice. Rheumatology (Oxford). 2007; 46(7): 1191-9
43. Wick M C Ernestam S. Lindblad S. Bratt J. Klareskog L van Vollenhoven RF. Adalimumab (Humira) restores clinical response in patients with secondary loss of effi cacy from infl iximab (Remicade) or etanercept (Enbrel): Results from the STURE registry at Karolinska University Hospital. Scand J Rheumatol. 2005; 34(5) : 353-8