Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial

Stanley Cohen1, Ahmed S. Samad2, Elaine Karis2, Bradley S. Stolshek2, Megha Trivedi2, Hao Zhang3, Girish Aras3, Greg Kricorian2, James B. Chung2
1Metroplex Clinical Research Center, Dallas, TX, USA
2US Medical, Amgen Inc., Thousand Oaks, CA, USA
3Biostatistics, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA

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Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: a synopsis. Am J Manag Care. 2014;20(7 Suppl):S128–35.

McArdle A, Pennington S, FitzGerald O. Clinical features of psoriatic arthritis: a comprehensive review of unmet clinical needs. Clin Rev Allergy Immunol. 2017. https://doi.org/10.1007/s12016-017-8630-7 .

Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68:1–26.

Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75:499–510.

Nam JL, Takase-Minegishi K, Ramiro S, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2017;76:1113–36.

Enbrel® (etanercept) prescribing information. Immunex Corporation, Thousand Oaks, CA. 2017. https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/enbrel/enbrel_pi.pdf .

Lethaby A, Lopez-Olivo MA, Maxwell L, Burls A, Tugwell P, Wells GA. Etanercept for the treatment of rheumatoid arthritis. Cochrane Datab Syst Rev. 2013;2013:CD004525.

Gladman DD, Bombardier C, Thorne C, et al. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011;38:1355–62.

Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712–21.

Jones GB, Collins DS, Harrison MW, Thyagarajapuram NR, Wright JM. Subcutaneous drug delivery: an evolving enterprise. Sci Transl Med. 2017. https://doi.org/10.1126/scitranslmed.aaf9166 .

Kim H, Park H, Lee SJ. Effective method for drug injection into subcutaneous tissue. Sci Rep. 2017;7:9613.

Zijlstra E, Jahnke J, Fischer A, Kapitza C, Forst T. Impact of injection speed, volume, and site on pain sensation. J Diabetes Sci Technol. 2018;12:163–8.

Hamuro L, Kijanka G, Kinderman F, et al. Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins. J Pharm Sci. 2017;106:2946–54.

Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995;41:169–75.

Henderson Berg MH, Carrasco D. Injection site reactions to biologic agents used in psoriasis and psoriatic arthritis. J Drugs Dermatol. 2017;16:695–8.

Bolge SC, Goren A, Tandon N. Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective. Patient Prefer Adherence. 2015;9:121–31.

Palmon SC, Lloyd AT, Kirsch JR. The effect of needle gauge and lidocaine pH on pain during intradermal injection. Anesth Analg. 1998;86:379–81.

Robb DM, Kanji Z. Comparison of two needle sizes for subcutaneous administration of enoxaparin: effects on size of hematomas and pain on injection. Pharmacotherapy. 2002;22:1105–9.

Laursen T, Hansen B, Fisker S. Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol. 2006;98:218–21.

Flanagan T, Wahl MJ, Schmitt MM, Wahl JA. Size doesn’t matter: needle gauge and injection pain. Gen Dent. 2007;55:216–7.

Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001;18:205–7.

Wolfe F, Michaud K. Assessment of pain in rheumatoid arthritis: minimal clinically significant difference, predictors, and the effect of anti-tumor necrosis factor therapy. J Rheumatol. 2007;34:1674–83.

Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002;20:287–90.