Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious

Scandinavian Journal of Rheumatology

Volumn 45, Issue 4, 2016, Pages 262-266

  Lindegaard, H M ^a   Johansen, P ^b   Grondal G ^c   Jensen, E C ^d   Juul, L ^e   Schlemmer, A M ^f   Agular, B ^g   Hansen, I M J ^h  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b HOLBÆK HOSPITAL   (Denmark)

^c LANDSPITALI UNIVERSITY HOSPITAL   (Iceland)

^d FREDERIKSBERG HOSPITAL   (Denmark)

^e GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^f AALBORG UNIVERSITY HOSPITAL   (Denmark)

^g Roche A S   (Denmark)

^h SVENDBORG HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; GLUCOCORTICOID; METHOTREXATE; TOCILIZUMAB; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; ANTIRHEUMATIC AGENT; C REACTIVE PROTEIN; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ADULT; ADVERSE DRUG REACTION; ARTICLE; CHILL; CLINICAL ARTICLE; CONTROLLED STUDY; DAS28; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FACE EDEMA; FATIGUE; FEMALE; FLUSHING; HEADACHE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; HYPERCHOLESTEROLEMIA; IMMUNOGENICITY; INFUSION RATE; INFUSION REACTION; MALE; MULTICENTER STUDY; NEUTROPENIA; OPEN STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SKIN LYMPHOMA; TENOSYNOVITIS; TREATMENT RESPONSE; AGED; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG HYPERSENSITIVITY; EDEMA; IMMUNOLOGY; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; C-REACTIVE PROTEIN; DRUG HYPERSENSITIVITY; EDEMA; FATIGUE; FEMALE; FLUSHING; GLUCOCORTICOIDS; HEADACHE; HUMANS; HYPERCHOLESTEROLEMIA; INFUSIONS, INTRAVENOUS; MALE; METHOTREXATE; MIDDLE AGED; NASOPHARYNGITIS; NEUTROPENIA; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84952787247     PISSN: 03009742     EISSN: 15027732     Source Type: Journal    
DOI: 10.3109/03009742.2015.1112030     Document Type: Article

References (25)

1. J.M.Dayer, E.Choy Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology 2010;49:15–24.
2. J.E.Gottenberg, J.M.Dayer, C.Lukas, B.Ducot, G.Chiocchia, A.Cantagrel, et al. Serum IL-6 and IL-21 are associated with markers of B cell activation and structural progression in early rheumatoid arthritis: results from the ESPOIR cohort. Ann Rheum Dis 2012;71:1243–8.
3. P.P.Tak, T.J.Smeets, M.R.Daha, P.M.Kluin, K.A.E.Meijers, R.Brand, et al. Analysis of the synovial cell infiltrate in early rheumatoid synovial tissue in relation to local disease activity. Arthritis Rheum 1997;40:217–25.
4. M.Mihara, K.Kasutani, M.Okazaki, A.Nakamura, S.Kawai, M.Sugimoto, et al. Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int Immunopharmacol 2005;5:1731–40.
5. N.Nishimoto, T.Kishimoto. Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb Exp Pharmacol 2008;181:151–60.
6. P.Emery, E.Keystone, H.P.Tony, A.Cantagrel, R.van Vollenhoven, A.Sanchez, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomized placebo-controlled trial. Ann Rheum Dis 2008;67:1516–23.
7. J.S.Smolen, A.Beaulieu, A.Rubbert-Roth, C.Ramos-Remus, J.Rovensky, E.Alecock, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet 2008;371:987–97.
8. M.C.Genovese, J.D.McKay, E.L.Nasonov, E.F.Mysler, N.A.da Silva, E.Alecock, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008;58:2968–80.
9. J.M.Kremer, R.Blanco, S.Brzosko, R.Burgos-Vargas, A.M.Halland, E.Vernon, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomised placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum 2011;63:609–21.
10. G.Jones, A.Sebba, J.Gu, M.B.Lowenstein, A.Calvo, J.J.Gomez-Reino, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis 2010;69:88–96.
11. N.Nishimoto, J.Hashimoto, N.Miyasaka, K.Yamamoto, S.Kawai, T.Takeuchi, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis 2007;66:1162–7.
12. N.Nishimoto, N.Miyasaka, K.Yamamoto, S.Kawai, T.Takeuchi, J.Azuma, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol 2009;19:12–19.
13. M.Dougados, K.Kissel, T.Sheeran, P.P.Tak, P.G.Conaghan, E.M.Mola, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis 2013;72:43–50.
14. C.Gabay, P.Emery, R.van Vollenhoven, A.Dikranian, R.Alten, K.Pavelka, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet 2013;381:1541–50.
15. M.Alperi, M.Belmonte-Serrano, P.Lluch, P.Trenor, J.Calvo-Alen, E.García-Fernández, et al. Tocilizumab infusion performed in 31 minutes in patients with arthritis is safe and well tolerated (abstract). Ann Rheum Dis 2012;71(Suppl 3):FRI0195.
16. G.Bukh, S.Larsen, S.S.Rasmussen, M.S.Hansen. Accelerated infusion-rate of tocilizumab for rheumatoid arthritis is well tolerated and safe (abstract). Ann Rheum Dis 2011;70(Suppl 3):AB1013–HP.
17. J.R.Maneiro, E.Salgado, J.J.Gomez-Reino. Immunogenicity of monoclonal antibodies against tumor necrosis factor used in chronic immune-mediated inflammatory conditions systematic review and meta-analysis. JAMA Intern Med 2013;173:1416–28.
18. M.Jani, A.Barton, R.B.Warren, C.E.M.Griffiths, H.Chinoy. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology 2014;53:213–22.
19. M.H.Buch, D.Bryer, S.Lindsay, B.Rees-Evans, A.Fairclough, P.Emery. Shortening infusion times for infliximab administration. Rheumatology (Oxford) 2006;45:485–6.
20. S.Fukuyo, K.Saito, K.Yamaoka, N.Sawamukai, S.Hirata, M.Nawata, et al. Efficacy and safety of reducing duration of infliximab infusion. Mod Rheumatol 2014;24:275–80.
21. R.F.Van Vollenhoven, E.Gullstrom, L.Klareskog. Feasibility of 1 hour infliximab infusions. Ann Rheum Dis 2005;64:654.
22. M.Can, F.Alibaz-Öner, S.Yılmaz-Öner, P.Atagündüz, N.İnanç, H.Direskeneli. Accelerated infusion rates of rituximab are well tolerated and safe in rheumatology practice: a single-centre experience. Clin Rheumatol 2013;32:87–90.
23. C.H.Pritchard, M.W.Greenwald, J.M.Kremer, N.B.Gaylis, W.Rigby, S.Zlotnick, et al. Safety of infusing rituximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study. BMC Musculoskelet Disord 2014;15:177–85.
24. G.Bukh, S.Larsen, S.S.Rasmussen, M.K.Mølgård, M.S.Hansen. Accelerated infusion-rate of rituximab for rheumatoid arthritis is well tolerated and safe (abstract). Arthritis Rheum 2008;58:ABS1885.
25. European Medicines Agency. Tocilizumab (RoActemra): summary of product characteristics 2014 (www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000955/human_med_001042.jsp&mid=WC0b01ac058001d124). Accessed 9 October 2014.