Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis

Naranjo A, Sokka T, Descalzo MA, Calvo-Alen J, Horslev-Petersen K, Luukkainen RK, Combe B, Burmester GR, Devlin J, Ferraccioli G, Morelli A, Hoekstra M, Majdan M, Sadkiewicz S, Belmonte M, Holmqvist AC, Choy E, Tunc R, Dimic A, Bergman M, Toloza S, Pincus T (2008) Cardiovascular disease in patients with rheumatoid arthritis: results from the QUEST-RA study. Arthritis Res Ther 10:R30 Armstrong DJ, McCausland EM, Quinn AD, Wright GD (2006) Obesity and cardiovascular risk factors in rheumatoid arthritis. Rheumatology (Oxford) 45:782–783 Gremese E, Tolusso B, Gigante MR, Ferraccioli G (2014) Obesity as a risk and severity factor in rheumatic diseases (autoimmune chronic inflammatory diseases). Front Immunol 5:576 Lu B, Hiraki LT, Sparks JA, Malspeis S, Chen CY, Awosogba JA, Arkema EV, Costenbader KH, Karlson EW (2014) Being overweight or obese and risk of developing rheumatoid arthritis among women: a prospective cohort study. Ann Rheum Dis 73:1914–1922 Baker JF, Ostergaard M, George M, Shults J, Emery P, Baker DG, Conaghan PG (2014) Greater body mass independently predicts less radiographic progression on X-ray and MRI over 1-2 years. Ann Rheum Dis 73:1923–1928 Vidal C, Barnetche T, Morel J, Combe B, Daien C (2015) Association of body mass index categories with disease activity and radiographic joint damage in rheumatoid arthritis: a systematic review and metaanalysis. J Rheumatol 42:2261–2269 Sandberg ME, Bengtsson C, Kallberg H, Wesley A, Klareskog L, Alfredsson L, Saevarsdottir S (2014) Overweight decreases the chance of achieving good response and low disease activity in early rheumatoid arthritis. Ann Rheum Dis 73:2029–2033 Liu Y, Hazlewood GS, Kaplan GG, Eksteen B, Barnabe C (2016) The impact of obesity on remission and disease activity in rheumatoid arthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken) 69:157–165 Gremese E, Carletto A, Padovan M, Atzeni F, Raffeiner B, Giardina AR, Favalli EG, Erre GL, Gorla R, Galeazzi M, Foti R, Cantini F, Salvarani C, Olivieri I, Lapadula G, Ferraccioli G (2013) Obesity and reduction of the response rate to anti-tumor necrosis factor alpha in rheumatoid arthritis: an approach to a personalized medicine. Arthritis Care Res (Hoboken) 65:94–100 Ottaviani S, Gardette A, Roy C, Tubach F, Gill G, Palazzo E, Meyer O, Dieude P (2015) Body mass index and response to rituximab in rheumatoid arthritis. Joint Bone Spine 82:432–436 Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, Merrill JT, Rowell L, Nasmyth-Miller C, Bao M, Wright S, Pope JE (2014) Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken) 66:1653–1661 Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF (2016) Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis 75:68–74 Gardette A, Ottaviani S, Sellam J, Berenbaum F, Liote F, Meyer A, Sibilia J, Fautrel B, Palazzo E, Dieude P (2016) Body mass index and response to tocilizumab in rheumatoid arthritis: a real life study. Clin Rheumatol 35:857–861 Pers YM, Godfrin-Valnet M, Lambert J, Fortunet C, Constant E, Mura T, Pallot-Prades B, Jorgensen C, Maillefert JF, Marotte H, Wendling D, Gaudin P (2015) Response to tocilizumab in rheumatoid arthritis is not influenced by the body mass index of the patient. J Rheumatol 42:580–584 Murthy B, Gao L, Yin J, White J, Zhou Z, Thanneer N, Kaul S, Delaet I, Corbo M (2011) Pharmacokinetics of subcutaneous abatacept support a fixed dosing regimen in adult patients with rheumatoid arthritis. Ann Rheum Dis 70(Suppl. 3):460 Iannone F, Finckh A, Neto D, Gomez-Reino J, Lie E, Canhao H, Pavelka K, Turesson C, Mariette X, Gottenberg JE, Hetland M, On behalf of Pan-EU-Registry on Abatacept (2014) Body mass does not affect clinical outcomes of therapy with abatacept in rheumatoid arthritis (RA) patients. A pan-European analysis of RA registries. Ann Rheum Dis 73(Suppl. 2):498–499 D’Agostino MA, Le Bars M, Taylor M, Chou B, Zhu J, Ranganath VK (2015) In patients with rheumatoid arthritis and an inadequate response to methotrexate, does body mass index influence the efficacy of abatacept on inflammation when measured by power doppler ultrasonography? Results from the APPRAISE study. Ann Rheum Dis 74(Suppl. 2):231 Nüßlein H, Alten R, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter H-H, Peichl P, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M (2014) Does body mass index impact long-term retention with abatacept in patients with RA who have received at least one prior biologic agent? 2-year results from a real-world, international, prospective study. Ann Rheum Dis 66(Suppl. 11):1088–1089 Nüßlein HG, Alten R, Galeazzi M, Lorenz HM, Nurmohamed MT, Bensen WG, Burmester GR, Peter H-H, Peichl P, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M (2016) Efficacy and prognostic factors of treatment retention with intravenous abatacept for rheumatoid arthritis: 24-month results from an international, prospective, real-world study. Clin Exp Rheumatol 34:489–499 Product monograph: Orencia (abatacept). Available at: http://www.bmscanada.ca/static/products/en/pm_pdf/ORENCIA_EN_PM.pdf. Accessed 14 December 2016 Orencia 250mg powder for concentrate for solution for infusion. Available at: http://www.medicines.org.uk/emc/medicine/19714/SPC/. Accessed 25 August 2016 Ma Y, Lin BR, Lin B, Hou S, Qian WZ, Li J, Tan M, Ma J, Li BH, Wang H, Wen AD, Guo YJ (2009) Pharmacokinetics of CTLA4Ig fusion protein in healthy volunteers and patients with rheumatoid arthritis. Acta Pharmacol Sin 30:364–371 Lon HK, Liu D, DuBois DC, Almon RR, Jusko WJ (2013) Modeling pharmacokinetics/pharmacodynamics of abatacept and disease progression in collagen-induced arthritic rats: a population approach. J Pharmacokinet Pharmacodyn 40:701–712 Corbo M, Valencia X, Raymond R, Summerill R, Agrawal S, Townsend R, Zhou Z, Wu D, Robinson D, Shergy W (2009) Subcutaneous administration of abatacept in patients with rheumatoid arthritis: pharmacokinetics, safety and immunogenicity. Ann Rheum Dis 68:S574 Corbo M, Valencia X, Raymond R, Summerill R, Agrawal S, Shergy W, Tay L (2008) A subcutaneous administration regimen for abatacept in patients with rheumatoid arthritis: pharmacokinetics, safety and immunogenicity. Arthritis Rheum 58:S307 Roy A, Mould DR, Wang XF, Tay L, Raymond R, Pfister M (2007) Modeling and simulation of abatacept exposure and interleukin-6 response in support of recommended doses for rheumatoid arthritis. J Clin Pharmacol 47:1408–1420 Iwahashi M, Inoue H, Matsubara T, Tanaka T, Amano K, Kanamono T, Nakano T, Uchimura S, Izumihara T, Yamazaki A, Karyekar C, Takeuchi T (2014) Efficacy, safety, pharmacokinetics, and immunogenicity of abatacept administered subcutaneously or intravenously in Japanese patients with rheumatoid arthritis and inadequate response to methotrexate: a phase II/III, randomized study. Mod Rheumatol 24:885–891 Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C III, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R (2011) Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheumatol 63:2854–2864 D’Agostino M, Alten R, Mysler E, Le Bars M, Murthy B, Heitzmann J, Vadanici R, Ferraccioli G (2016) Body mass index does not affect response to subcutaneous or intravenous abatacept in patients with rheumatoid arthritis. Arthritis Rheum 68(Suppl 10):abstract 1583 Nüßlein H, Alten R, Galeazzi M, Lorenz HM, Boumpas D, Nurmohamed MT, Bensen WG, Burmester GR, Peter HH, Rainer F, Pavelka K, Chartier M, Poncet C, Rauch C, Le Bars M (2014) Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord 15:14 Kaeley GS, Ranganath VK, MacCarter DK, Pangan AL, Wang X, Kalabic J (2016) Clinical responses and synovial vascularity in obese rheumatoid arthritis patients treated with adalimumab and methotrexate. Arthritis Rheum 68(Suppl 10):abstract 640 Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Lu P, Rowell L, Bao M, Mysler EF (2014) A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 73:69–74 Davis P, Nadler S, Rouleau K, Suchard S (2005) Abatacept (CTLA4-Ig) modulates human T-cell proliferation and cytokine production but does not affect lipopolysaccharide-induced tumor necrosis factor alpha production by monocytes. Arthritis Res Ther 7(Suppl 1):P21 Hasegawa M, Imai Y, Hiraoka M, Ito K, Roy A (2011) Model-based determination of abatacept exposure in support of the recommended dose for Japanese rheumatoid arthritis patients. J Pharmacokinet Pharmacodyn 38:803–832 Bond A, Asher R, Jackson R, Sager K, Martin K, Kneebone A, Philips S, Taylor W, Subramanian S (2016) Comparative analysis of the influence of clinical factors including BMI on adalimumab and infliximab trough levels. Eur J Gastroenterol Hepatol 28:271–276 Takeuchi T, Miyasaka N, Inui T, Yano T, Yoshinari T, Abe T, Koike T (2016) Both high titer of RF/ACPA at baseline is closely linked with high level of baseline plasma TNF level which resulted in low drug level and low clinical response in infliximab treatment in RA patients: post-hoc analysis of a double-blind clinical study (RISING study). Ann Rheum Dis 75:144–145 Jin JF, Zhu LL, Chen M, Xu HM, Wang HF, Feng XQ, Zhu XP, Zhou Q (2015) The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection. Patient Prefer Adherence 9:923–942 Zhang J, Xie F, Yun H, Chen L, Muntner P, Levitan EB, Safford MM, Kent ST, Osterman MT, Lewis JD, Saag K, Singh JA, Curtis JR (2016) Comparative effects of biologics on cardiovascular risk among older patients with rheumatoid arthritis. Ann Rheum Dis 75:1813–1818 Nurmohamed MT, Heslinga M, Kitas GD (2015) Cardiovascular comorbidity in rheumatic diseases. Nat Rev Rheumatol 11:693–704 Castañeda S, Nurmohamed MT, González-Gay MA (2016) Cardiovascular disease in inflammatory rheumatic diseases. Best Pract Res Clin Rheumatol 30:851–869 Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, Kvien TK, Dougados M, Radner H, Atzeni F, Primdahl J, Södergren A, Wallberg Jonsson S, van Rompay J, Zabalan C, Pedersen TR, Jacobsson L, de Vlam K, Gonzalez-Gay MA, Semb AG, Kitas GD, Smulders YM, Szekanecz Z, Sattar N, Symmons DP, Nurmohamed MT (2017) EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis 76:17–28 Genovese MC, Pacheco-Tena C, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW III, Nasonov E, Durez P, Delaet I, Teng J, Alten R (2014) Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol 41:629–639