9 research outputs found

    Efficacy, pharmacokinetics, and tolerability of subcutaneous secukinumab injections with 2 mL prefilled syringes (300 mg) in adult subjects with moderate to severe plaque psoriasis

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    Sigurgeirsson B, Schaekel K, Hong C-H, et al. Efficacy, pharmacokinetics, and tolerability of subcutaneous secukinumab injections with 2 mL prefilled syringes (300 mg) in adult subjects with moderate to severe plaque psoriasis. Journal of the American Academy of Dermatology. 2021;85(3, Suppl.):AB150

    27519 Efficacy, pharmacokinetics, and tolerability of subcutaneous secukinumab injections with 2 mL prefilled syringes (300 mg) in adult subjects with moderate to severe plaque psoriasis

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    Sigurgeirsson B, Schäkel K, Hong C-H, et al. 27519 Efficacy, pharmacokinetics, and tolerability of subcutaneous secukinumab injections with 2 mL prefilled syringes (300 mg) in adult subjects with moderate to severe plaque psoriasis. Journal of the American Academy of Dermatology. 2021;85(3 (Suppl.): AB150

    27599 Secukinumab administration by a 2 mL autoinjector demonstrates high efficacy with comparable safety and tolerability in adult patients with plaque psoriasis: 16-week results from MATURE

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    Sigurgeirsson B, Browning J, Tyring S, et al. 27599 Secukinumab administration by a 2 mL autoinjector demonstrates high efficacy with comparable safety and tolerability in adult patients with plaque psoriasis: 16-week results from MATURE. Journal of the American Academy of Dermatology. 2021;85(3 (Suppl.): AB154

    Secukinumab administration by a 2 mL autoinjector demonstrates high efficacy with comparable safety and tolerability in adult patients with plaque psoriasis: 16-week results from MATURE

    No full text
    Sigurgeirsson B, Browning J, Tyring S, et al. Secukinumab administration by a 2 mL autoinjector demonstrates high efficacy with comparable safety and tolerability in adult patients with plaque psoriasis: 16-week results from MATURE. Journal of the American Academy of Dermatology. 2021;85(3, Suppl.):AB154

    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

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    Sigurgeirsson B, Schakel K, Hong C-H, et al. 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. Journal of Dermatological Treatment. 2022;33(3):1718-1726.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

    High Efficacy, Safety, and Tolerability of Secukinumab Injection with 2 mL Auto-injector (300 Mg) in Adult Patients with Moderate to Severe Plaque Psoriasis: 52-week Results from MATURE, a Randomised, Placebo-controlled Trial

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    Sigurgeirsson B, Browning J, Tyring S, et al. High Efficacy, Safety, and Tolerability of Secukinumab Injection with 2 mL Auto-injector (300 Mg) in Adult Patients with Moderate to Severe Plaque Psoriasis: 52-week Results from MATURE, a Randomised, Placebo-controlled Trial. Arthritis &amp; Rheumatology . 2021;73(Suppl. 9):448-449

    Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial

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    Sigurgeirsson B, Browning J, Tyring S, et al. Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial. Dermatologic Therapy . 2022;35(3): e15285.Convenient administration is an important factor for treatment adherence in patients with psoriasis. MATURE study reports the efficacy, safety, tolerability, and pharmacokinetics (PKs) of secukinumab 300 mg 2 ml autoinjector (AI) from MATURE trial (NCT03589885). Eligible patients were randomized to secukinumab 300 mg 2 ml AI or 2x 1 ml prefilled syringe (PFS) or placebo. The co-primary endpoints were psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates at Week 12 versus placebo. Other endpoints included PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs, 2 ml AI usability rated using self-injection assessment questionnaire (SIAQ), and safety. The study met both co-primary and secondary endpoints (p < 0.0001). Secukinumab 300 mg 2 ml AI and 2x 1 ml PFS treatments led to superior PASI75/90/100 (2 ml AI: 95.1%/75.6%/43.9%; 2x 1 mL PFS: 83.2%/62.6%/37.5% and placebo: 10%/5.0%/0.0%, respectively), IGA, and DLQI 0/1 responses compared with placebo, and efficacy was sustained through 52 weeks. SIAQ results showed high usability of self-injection with 2 mL AI device. No new safety signals were observed. Study design may bias the interpretation of safety profile after Week 12, due to different exposure of secukinumab versus placebo. Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration

    L’administration du sécukinumab par un auto-injecteur de 2 mL démontre une efficacité élevée avec une sécurité et une tolérance comparables chez les patients adultes atteints de psoriasis en plaques : résultats à 16 semaines de l’étude MATURE

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    Sigurgeirsson B, Browning J, Tyring S, et al. L’administration du sécukinumab par un auto-injecteur de 2 mL démontre une efficacité élevée avec une sécurité et une tolérance comparables chez les patients adultes atteints de psoriasis en plaques : résultats à 16 semaines de l’étude MATURE. Annales de Dermatologie et de Vénéréologie - FMC. 2021;1(8): A347

    Secukinumab in plaque psoriasis--results of two phase 3 trials.

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