Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled <scp>JUNCTURE</scp> trial

Lacour, Jean‐Philippe; Paul, C.; Jazayeri, S.; Papanastasiou, P.; Xu, Cong; Nyirady, Judit; Fox, Todd; Papavassilis, Charis

doi:10.1111/jdv.14073

Cited by 46 publications

(37 citation statements)

References 22 publications

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“…Moreover, the majority of the patients found usage of an autoinjector easy or very easy, with no external help required. These observations are in agreement with those recently reported for the secukinumab autoinjector in the psoriasis JUNCTURE trial [ 23 ].…”

Section: Discussionsupporting

confidence: 93%

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

et al. 2018

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BackgroundThe study aimed to assess 52-week efficacy and safety of secukinumab self-administration by autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study (ClinicalTrials.gov NCT01989468).MethodsPatients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naïve, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ).ResultsOverall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naïve and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported.ConclusionsSecukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of autoinjector was observed. The safety profile was consistent with that reported previously.Trial registrationClinicalTrials.gov NCT01989468. Registered 21 November 2013.EudraCT 2013–004002-25. Registered 17 December 2013.Electronic supplementary materialThe online version of this article (10.1186/s13075-018-1551-x) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 93%

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

et al. 2018

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“…The JUNCTURE and FEATURE Phase III trials demonstrated that secukinumab administered by autoinjector pen or prefilled syringe continues to be well-tolerated at 1 year under the currently-approved dosing regimen. 19 , 37 No increased risk of injection-site reactions has been reported with secukinumab treatment with either method of administration. Patients who are able to comply with a regular monthly dosing regimen may benefit from secukinumab treatment due to its convenience over older biologic therapies, as well as for other reasons outlined in this manuscript.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical efficacy of secukinumab for psoriasis was evaluated with secondary endpoints assessing the usability and tolerability of an auto-injector pen in JUNCTURE, another randomized, double-blind, placebo-controlled Phase III trial. 19 The coprimary endpoints for this study were the proportions of patients achieving PASI 75 and IGA 0/1 at week 12 as compared to placebo. These coprimary endpoints were achieved, with significantly more patients treated with secukinumab achieving PASI 75 (86.7% vs 3.3%) and IGA 0/1 (73.3% vs 0%).…”

Section: Efficacy In Plaque Psoriasismentioning

confidence: 99%

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Secukinumab in the treatment of psoriasis: patient selection and perspectives

Yang¹,

Beck²,

Liao³

2018

PTT

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Secukinumab is a human monoclonal antibody targeting IL-17A that has been approved for three indications: moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In Phase III clinical trials for each of these three indications, secukinumab has proven to be both highly efficacious and well-tolerated. However, several biologic medications are currently approved for the treatment of moderate-to-severe plaque psoriasis, and many demonstrate excellent efficacy and safety. Due to this wide selection, it is often unclear how to choose biologics for specific patients. Important considerations in biologic selection include clinical efficacy, safety, cost, convenience, onset of action, and management of comorbid disease. This article aims to outline the key considerations in patient selection for the treatment of plaque psoriasis with secukinumab.

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“…Various factors contribute to NIEs. The chemical and physical properties of biologics that may contribute to NIEs are summarized in Table 3 (Abbvie, 2018;Eshtiaghi & Gooderham, 2018;European Medicines Agency, 2005Ferris et al, 2019;Immunex Corporation, 2016;Kavanaugh et al, 2012;Lacour et al, 2017;Nakamura et al, 2017;Papp et al, 2016;Sator, 2018;Savage, Wittmann, Mcgonagle, & Helliwell, 2015;US Food and Drug Administration, 2008, 2011, 2017a, 2017c, 2017d, 2018a, 2018b, 2018c, 2019a, 2019bvan der Heijde et al, 2018).…”

Section: Types Of Negative Injection Experiencesmentioning

confidence: 99%

Classification and mitigation of negative injection experiences with biologic medications

Fernandez

Madsen

Krase

et al. 2020

Dermatologic Therapy

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Injection site reactions with biologic medications are encountered with variable frequency. Although there is no clear definition, they commonly manifest with pain and irritation at the injection site. Previously proposed reaction classification systems may be impractical or insufficient, and more intuitive nomenclature may benefit clinical dermatologists and patients. Negative injection experiences (NIE) are common reasons for biologic medication nonadherence. Here we provide clinical classifications and recommendations for mitigating these reactions. We categorized NIEs into the following: (a) physical, due to the needle and injection process, (b) irritant, related to properties of the injected solution, and (c) allergic, both immediate and delayed.

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Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial

Abstract: Self-administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.

Cited by 46 publications

References 22 publications

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

Secukinumab in the treatment of psoriasis: patient selection and perspectives

Classification and mitigation of negative injection experiences with biologic medications

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