RENACER study: Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoid arthritis-treated patients from a Spanish multicenter national database

References

• Carmona L, Villaverde V, Hernandez-Garcia C, Ballina J, Gabriel R, Laffon A. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology (Oxford). 2002;41:88–95.
   PubMed Web of Science ®Google Scholar
• 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;38:727–35.
   PubMed Web of Science ®Google Scholar
• 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;39:34–40.
   PubMed Web of Science ®Google Scholar
• Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2005;7:R796–806.
   PubMed Web of Science ®Google Scholar
• Prevoo ML, van’t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44–8.
   PubMed Web of Science ®Google Scholar
• Hetland ML, Lindegaard HM, Hansen A, Podenphant J, Unker-skov J, Ringsdal VS, et al. Do changes in prescription practice in patients with rheumatoid arthritis treated with biological agents affect treatment response and adherence to therapy? Results from the nationwide Danish DANBIO Registry. Ann Rheum Dis. 2008;67:1023–6.
   PubMed Web of Science ®Google Scholar
• Zink A, Strangfeld A, Schneider M, Herzer P, Hierse F, Stoy-anova-Scholz M, et al. Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study: comparison of patients according to their eligibility for major randomized clinical trials. Arthritis Rheum. 2006;54:3399–407.
   PubMed Web of Science ®Google Scholar
• Kristensen LE, Saxne T, Nilsson JA, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;8:R174.
   PubMed Web of Science ®Google Scholar
• Chatzidionysiou K, Kristensen LE, Eriksson J, Askling J, van Vollenhoven R. For the Artis Group. Effectiveness and survival-on-drug of certolizumab pegol in rheumatoid arthritis in clinical practice: results from the national Swedish register. Scand J Rheumatol. 2015;18:1–7.
   Web of Science ®Google Scholar
• Iannone F, Gremese E, Atzeni F, Biasi D, Botsios C, Cipriani P. GruppoItaliano di Studio sulle Early Arthritides (GISEA). Longterm retention of tumor necrosis factor-α inhibitor therapy in a large Italian cohort of patients with rheumatoid arthritis from the GISEA registry: an appraisal of predictors. J Rheumatol. 2012;39:1179–84.
   PubMed Web of Science ®Google Scholar
• Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, On Behalf of All Departments of Rheumatology in Denmark. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab. Arthritis Rheumat. 2010;62:22–32.
   PubMed Web of Science ®Google Scholar
• 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;31:315–24.
   PubMed Web of Science ®Google Scholar
• Sociedad Española de Reumatología [sede Web]. Madrid: Sociedad Española de Reumatología [accedido Oct 2011]. Guía de práctica clínica para el manejo de la artritis reumatoide 2007. Available at: http://www.ser.es/practicaClinica/GUIPCAR_2007/Menu0_Principal.php.
   Google Scholar
• Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford). 2003;42(2):244–57.
   PubMed Web of Science ®Google Scholar
• Kievit W, Adang EM, Fransen J, Kuper HH, van de Laar MA, Jansen TL, et al. The effectiveness and medication costs of three anti-tumour necrosis factor alpha agents in the treatment of rheumatoid arthritis from prospective clinical practice data. Ann Rheum Dis. 2008;67:1229–34.
   PubMed Web of Science ®Google Scholar
• 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;58:3319–29.
   PubMed Web of Science ®Google Scholar
• Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014;24:715–24.
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Eguchi K, et al. Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate: 52-week results from an open-label extension of the HIKARI study. Mod Rheumatol. 2014;24:725–33.
   PubMed Web of Science ®Google Scholar
• Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial. Mod Rheumatol. 2014;24:552–60.
   PubMed Web of Science ®Google Scholar
• Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. Ann Rheum Dis. 2015. [Epub ahead of print]. doi: 10.1136/annrheumdis-2015-207511.
   PubMed Web of Science ®Google Scholar
• Blom M, Kievit W, Kuper HH, Jansen TL, Visser H, den Broeder AA, et al. Frequency and effectiveness of dose increase of adalimumab, etanercept, and infliximab in daily clinical practice. Arthritis Care Res (Hoboken). 2010;62:1335–41.
   PubMed Web of Science ®Google Scholar
• Marchesoni A, Zaccara E, Gorla R, Bazzani C, Sarzi-Puttini P, Atzeni F, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann NY Acad Sci. 2009;1173:837–46.
   PubMed Web of Science ®Google Scholar
• Kaneko A, Hirano Y, Fujibayashi T, Hattori Y, Terabe K, Kojima T, et al. Twenty-four-week clinical results of adalimumab therapy in Japanese patients with rheumatoid arthritis: retrospective analysis for the best use of adalimumab in daily practice. Mod Rheumatol. 2013;23:466–77.
   PubMed Web of Science ®Google Scholar
• Bennett AN, Peterson P, Zain A, Grumley J, Panayi G, Kirkham B. Adalimumab in clinical practice. Outcome in 70 rheumatoid arthritis patients, including comparison of patients with and without previous anti-TNF exposure. Rheumatology. 2005;44:1026–31.
   PubMed Web of Science ®Google Scholar
• Markatseli TE, Alamanos Y, Saougou I, Voulgari PV, Drosos AA. Survival of TNF-alpha antagonists in rheumatoid arthritis: a long-term study. Clin Exp Rheumatol. 2012;30:31–8.
   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;22:327–38.
   PubMed Web of Science ®Google Scholar
• Flouri I, Markatseli TE, Voulgari PV, Boki KA, Papadopoulos I, Settas L, et al. Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival. Semin Arthritis Rheum. 2014;43:447–57.
   PubMed Web of Science ®Google Scholar
• Atzeni F, Sarzi-Puttini P, Botsios C, Carletto A, Cipriani P, Favalli EG, et al. Long-term anti-TNF therapy and the risk of serious infections in a cohort of patients with rheumatoid arthritis: Comparison of adalimumab, etanercept and infliximab in the GISEA registry. Autoimmun Rev. 2012;12:225–9.
   PubMed Web of Science ®Google Scholar
• Kristensen LE, Kapetanovic MC, Gulfe A, Soderlin M, Saxne T, Geborek P. Predictors of response to anti-TNF therapy according to ACR and EULAR criteria in patients with established RA: Results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford). 2008;47:495–9.
   PubMed Web of Science ®Google Scholar
• Hyrich KL, Watson KD, Silman AJ, Symmons DP. Predictors of response to anti-TNF-alpha therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Rheumatology (Oxford). 2006;45:1558–65.
   PubMed Web of Science ®Google Scholar
• Abhishek A, Butt S, Gadsby K, Zhang W, Deighton CM. Anti-TNF-alpha agents are less effective for the treatment of rheumatoid arthritis in current smokers. J Clin Rheumatol. 2010;16:15–18.
   PubMed Web of Science ®Google Scholar
• Rojas-Serrano J, Pérez LL, García CG, Moctezuma F, Álvarez-Hernández E, Vázquez-Mellado J, et al. Current smoking status is associated to a non-ACR 50 response in early rheumatoid arthritis. A cohort study. Clin Rheumatol. 2011;30:1589–93.
   PubMed Web of Science ®Google Scholar
• Söderlin MK, Petersson IF, Geborek P. The effect of smoking on response and drug survival in rheumatoid arthritis patients treated with their first anti-TNF drug. Scand J Rheumatol. 2012;41:1–9.
   PubMed Web of Science ®Google Scholar