Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis: HAWK study postmarketing surveillance in Japan

References

• Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum Dis Clin North Am. 2001;27(2):269–81.
   PubMed Web of Science ®Google Scholar
• Yamanaka H, Sugiyama N, Inoue E, Taniguchi A, Momohara S. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014;24(1):33–40.
   PubMed Web of Science ®Google Scholar
• Furuya H, Kasama T, Isozaki T, Umemura M, Otsuka K, Isojima S, et al. Effect of TNF antagonists on the productivity of daily work of patients with rheumatoid arthritis. J Multidiscip Healthc. 2013;6:25–30.
   PubMedGoogle Scholar
• Emery P, Sebba A, Huizinga TW. Biologic and oral disease-modifying antirheumatic drug monotherapy in rheumatoid arthritis. Ann Rheum Dis. 2013;72(12):1897–904.
   PubMed Web of Science ®Google Scholar
• Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625–39.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, 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(3):492–509.
   PubMed Web of Science ®Google Scholar
• Bianchi G, Caporali R, Todoerti M, Mattana P. Methotrexate and rheumatoid arthritis: current evidence regarding subcutaneous versus oral routes of administration. Adv Ther. 2016;33(3):369–78.
   PubMed Web of Science ®Google Scholar
• Mouterde G, Baillet A, Gaujoux-Viala C, Cantagrel A, Wendling D, Le Loët X, et al. Optimizing methotrexate therapy in rheumatoid arthritis: a systematic literature review. Joint Bone Spine. 2011;78(6):587–92.
   PubMed Web of Science ®Google Scholar
• Verstappen SM, Jacobs JW, van der Veen MJ, Heurkens AH, Schenk Y, ter Borg EJ, et al. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis. 2007;66(11):1443–9.
   PubMed Web of Science ®Google Scholar
• Visser K, Katchamart W, Loza E, Martinez-Lopez JA, Salliot C, Trudeau J, et al. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Ann Rheum Dis. 2009;68(7):1086–93.
   PubMed Web of Science ®Google Scholar
• Seto Y, Tanaka E, Inoue E, Nakajima A, Taniguchi A, Momohara S, et al. Studies of the efficacy and safety of methotrexate at dosages over 8 mg/week using the IORRA cohort database. Mod Rheumatol. 2011;21(6):579–93.
   PubMed Web of Science ®Google Scholar
• Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T, et al. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014;53(5):904–13.
   PubMed Web of Science ®Google Scholar
• Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T, et al. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012;31(12):1713–21.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014;24(3):390–8.
   PubMed Web of Science ®Google Scholar
• Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol. 2012;22(4):498–508.
   PubMed Web of Science ®Google Scholar
• Takeuchi T, Yamanaka H, Ishiguro N, Miyasaka N, Mukai M, Matsubara T, et al. Adalimumab, a human anti-TNF monoclonal antibody, outcome study for the prevention of joint damage in Japanese patients with early rheumatoid arthritis: the HOPEFUL 1 study. Ann Rheum Dis. 2014;73(3):536–43.
   PubMed Web of Science ®Google Scholar
• Takeuchi T, Tanaka Y, Kaneko Y, Tanaka E, Hirata S, Kurasawa T, et al. Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study). Mod Rheumatol. 2012;22(3):327–38.
   PubMed Web of Science ®Google Scholar
• Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949;140(8):659–62.
   PubMed Web of Science ®Google Scholar
• Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of disease activity score (DAS)28- erythrocyte sedimentation rate and DAS28- C-reactive protein threshold values. Ann Rheum Dis. 2007;66(3):407–9.
   PubMed Web of Science ®Google Scholar
• Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017;3(1):e000382.
   PubMed Web of Science ®Google Scholar
• Alonso-Ruiz A, Pijoan JI, Ansuategui E, Urkaregi A, Calabozo M, Quintana A. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord. 2008;9:52.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Van Der Heijde DM, St Clair EW, Emery P, Bathon JM, Keystone E, et al. Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial. Arthritis Rheum. 2006;54(3):702–10.
   PubMed Web of Science ®Google Scholar
• Aletaha D, Smolen J, Ward MM. Measuring function in rheumatoid arthritis: identifying reversible and irreversible components. Arthritis Rheum. 2006;54(9):2784–92.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Kivitz AJ, Kupper H, Arulmani U, Florentinus S, Goss SL, et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis. 2015;74(6):1037–44.
   PubMed Web of Science ®Google Scholar
• Oh K, Ito S, Unno M, Kobayashi D, Azuma C, Abe A, et al. The rate of decrease in the disease activity of rheumatoid arthritis during treatment with adalimumab depends on the dose of methotrexate. Intern Med. 2015;54(9):1035–41.
   PubMed Web of Science ®Google Scholar
• Nakashima Y, Miyahara H, Kondo M, Fukuda T, Harada H, Haraguchi A, et al. Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: results from registered data analyses. Mod Rheumatol. 2017;27(1):15–21.
   PubMed Web of Science ®Google Scholar