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

Abstract

Background

Evidence shows good tolerability in patients for subcutaneous injection volumes up to 3 mL.

Objectives

We investigated efficacy, pharmacokinetics, and tolerability of secukinumab 300 mg/2 mL pre-filled syringe (PFS) in patients with moderate to severe plaque psoriasis.

Methods

ALLURE was a 52-week, multicenter, randomized (1:1:1), double-blind, placebo-controlled, parallel-group study. Co-primary endpoints were secukinumab Psoriasis Area Severity Index (PASI) 75 and Investigator’s Global Assessment modified 2011 0/1 (IGA mod 2011 0 or 1) responses at week 12 versus placebo. Other endpoints included the Self-Injection Assessment Questionnaire (SIAQ), and the ability to follow the instructions for use (IFU).

Results

Overall, 214 patients were randomized. The secukinumab 300 mg/2 mL PFS showed superiority over placebo for both PASI 75 (88.9% versus 1.7%; p<.0001) and IGA mod 2011 0 or 1 (76.4% versus 1.4%; p<.0001) responses at week 12. All secondary efficacy endpoints were met. The SIAQ scores were similar across groups and improved similarly over 12 weeks. All patients completed critical steps in the IFU at week 1.

Conclusions

The secukinumab 300 mg/2 mL PFS groups showed superiority versus placebo, and it was a safe, effective, and convenient option for patients with psoriasis. NCT02748863.

Keywords:

• Secukinumab
• pre-filled syringe
• psoriasis
• patient satisfaction
• self-administration

Acknowledgements

The authors thank Avinash Thakur and Mohammad Fahad Haroon (Novartis Healthcare Pvt. Ltd, Hyderabad) for editorial and medical writing support, which was funded by Novartis Pharma AG, Basel, Switzerland in accordance with the Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Disclosure statement

Bardur Sigurgeirsson has consulted for Novartis and several other pharmaceutical companies. He has served on an advisory board for Novartis and several other pharmaceutical companies. Knut Schäkel has been advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Boehringer-Ingelheim, Chugai Pharma, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Medac, Merck Serono, MSD, Novartis, Pfizer, Polichem SA, Regeneron Pharmaceutical, Sanofi-Aventis, Schering-Plough, UCB Pharma, VBL therapeutics. Chih-Ho Hong is a researcher/consultant/advisor for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Dermira, Dermavant, DS Biopharma, Galderma, GlaxoSmithKline, Janssen, LEO Pharma, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB. Isaak Effendy reports no conflict of interest. Waldemar Placek performed clinical trials for Amgen Inc, Maruho Europe Limited, Merck Sharp and Dohme Corp, Mylan, Novartis Poland Sp. z o.o., Johnson and Johnson, Moberg Pharma AB publ, Eli Lilly, Menlo, KYMAB, Bristol Meyers, CTC Team, Boehringer Ingelheim RCV GmbH and Co KG. Phoebe Rich has participated in advisory boards and/or as an investigator and/or speaker and received grants and/or honoraria from Arcutis Inc., Bristol-Myers Squibb, Centocor, Dermavant, Eli Lilly, Kadmon, Merck, Novartis, Pfizer, Sun Pharma, and UCB. Deborah Keefe is an employee of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Gerard Bruin is an employee of Novartis Institutes for Biomedical Research, Basel, Switzerland. Rong Fu is an employee of Novartis Institute for Biomedical Research, Shanghai, China. Pascal Charef, Isabelle Hampele, and Manmath Patekar are employees of Novartis Pharma AG, Basel, Switzerland.

Data availability statement

The datasets generated and/or analyzed during the current study are not publicly available. Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The data may be requested from the corresponding author of the manuscript.

Additional information

Funding

The study was sponsored by Novartis Pharma AG, Basel, Switzerland.