1,513
Views
3
CrossRef citations to date
0
Altmetric
Articles

Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study

ORCID Icon, , ORCID Icon, ORCID Icon, , , , , , , & show all
Pages 1718-1726 | Received 18 Jan 2021, Accepted 08 Mar 2021, Published online: 26 Apr 2021

References

  • Augustin M, Holland B, Dartsch D, et al. Adherence in the treatment of psoriasis: a systematic review. Dermatology. 2011;222(4):363–374.
  • Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029–1072.
  • Irvine DJ, Su X, Kwong B. Routes of delivery for biological drug products. In: Manmohan Singh, editor. Biological drug products: development and strategies. Chapel Hill, NC: John Wiley & Sons; 2013. p. 677–724.
  • Guerci B, Chanan N, Kaur S, et al. Lack of treatment persistence and treatment nonadherence as barriers to glycaemic control in patients with type 2 diabetes. Diabetes Ther. 2019;10(2):437–449.
  • Armstrong AW, Vender R, Kircik L. Secukinumab in the treatment of palmoplantar, nail, scalp, and pustular psoriasis. J Clin Aesthet Dermatol. 2016;9(6 Suppl. 1):S12–S16.
  • Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373(26):2534–2548.
  • Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015;172(2):484–493.
  • Deodhar A, Mease PJ, McInnes IB, et al. Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data. Arthritis Res Ther. 2019;21(1):111.
  • Gottlieb AB, Blauvelt A, Prinz JC, et al. Secukinumab self-administration by prefilled syringe maintains reduction of plaque psoriasis severity over 52 weeks: results of the FEATURE trial. J Drugs Dermatol. 2016;15(10):1226–1234.
  • Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014;371(4):326–338.
  • Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082–1090.
  • Reich K, Warren RB, Coates LC, et al. Long-term efficacy and safety of secukinumab in the treatment of the multiple manifestations of psoriatic disease. J Eur Acad Dermatol Venereol. 2020;34(6):1161–1173.
  • US Prescribing Information; 2020; [cited 2020 17 Sep]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf
  • EUSmPC; 2020; [cited 17 Sep 2020]. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf
  • Ingle RG, Agarwal AS. Pre-filled syringe – a ready-to-use drug delivery system: a review. Expert Opin Drug Deliv. 2014;11(9):1391–1399.
  • Makwana S, Basu B, Makasana Y, et al. Prefilled syringes: an innovation in parenteral packaging. Int J Pharm Investig. 2011;1(4):200–206.
  • Dias C, Abosaleem B, Crispino C, et al. Tolerability of high-volume subcutaneous injections of a viscous placebo buffer: a randomized, crossover study in healthy subjects. AAPS PharmSciTech. 2015;16(5):1101–1107.
  • Jezek J, Rides M, Derham B, et al. Viscosity of concentrated therapeutic protein compositions. Adv Drug Deliv Rev. 2011;63(13):1107–1117.
  • Narasimhan C, Mach H, Shameem M. High-dose monoclonal antibodies via the subcutaneous route: challenges and technical solutions, an industry perspective. Ther Deliv. 2012;3(7):889–900.
  • Berteau C, Filipe-Santos O, Wang T, et al. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Devices (Auckl). 2015;8:473–484.
  • Heise T, Nosek L, Dellweg S, et al. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014;16(10):971–976.
  • Saluja A, Kalonia DS. Nature and consequences of protein-protein interactions in high protein concentration solutions. Int J Pharm. 2008;358(1–2):1–15.
  • NIH. Clinical center patient education materials: giving a subcutaneous injection; 2012. http://www.med.umich.edu/1libr/NursingUnits/Giving_Subcutaneous_Injection.pdf
  • Bruin G, Hockey HP, La Stella P, et al. Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients. Br J Clin Pharmacol. 2020;86(2):338–351.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.