Secukinumab

Refrigerated StorageNew Medicines ·
29215811000001103

Refrigerated Storage

CosentyxNovartis Pharmaceuticals UK Ltd

Novartis Pharmaceuticals UK Ltd
Cosentyx
Solution for injection in pre-filled pen and solution for injection in pre-filled syringe, 150mg

In the event of an inadvertent temperature excursion the following data may be used: Cosentyx may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C. Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk.

Contact Novartis in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Reduce to 4 days from the day of exposure (but not exceeding the original expiry date)
No
14 May 2020
London Medicines Information Service

New Medicines

CosentyxActive ankylosing spondylitis (AS) - new dosing regimen up to 300mg

Information

Cosentyx
New dosing regimen
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
October 2019
Nov 19Each 300 mg dose is given as two subcutaneous injections of 150 mg. 150mg soln for inj in pre-filled pen or syringe, 2=£1218.78 [4,5]
Oct 19Novartis announces approval of a Cosentyx label update in Europe to include dosing flexibility in AS, with up-titration to 300 mg for patients with active versions of the disease. Approval was based on data from MEASURE 3, a three-year study that explored the tolerability and efficacy of Cosentyx in patients with AS, and found that response rates were greater in the 300mg dose group, particularly among patients with previous anti-TNF exposure, compared with the recommended 150 mg dose [3].

Category

Fully human IgG1k anti-IL17A antibody
Prevalence is 0.1-2% of the general population, with the highest prevalence in northern European countries and the lowest in people of Afro-Caribbean descent [1].
Active ankylosing spondylitis (AS) - new dosing regimen up to 300mg
Subcutaneous injection

Trial or other data

Dec 17PIII MEASURE 3 study completes [4].
Jan 14PIII MEASURE 3 study to generate 16-week efficacy data for secukinumab 150mg and 300mg, as well as up to 3-year efficacy, safety and tolerability data in 226 adults with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy starts (NCT02008916). Patients will be recruited in countries such as the US, EU & UK. Collection of primary outcome data is due to complete Feb 15 [4].

CosentyxNon-radiographic axial spondyloarthritis - severe, active in adults who have responded inadequately to conventional therapy

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
April 2020
May 20The EC has approved secukinumab for the treatment of adult patients with active non-radiographic axial spondyloarthritis [9].
Mar 20Recommended for EU approval by CHMP - the additional indication is "the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs)."[8]
Sep 19Data from PREVENT trial submitted for approval by the EMA in Europe. 52-week follow-up data from PREVENT, expected later this year, will support the US submission [7].
Dec 18Filings still planned for 2019 [5].
Jun 17Filings now expected 2019 [4].
Dec 16Filings planned for 2018 [3].

Category

Fully human IgG1k anti-IL17A antibody
Estimates suggest 1-2% of the UK population have spondyloarthritis, roughly the same proportion as rheumatoid arthritis. It is clinically more common in men than women, with a ratio of approximately 5:13 [2].
Non-radiographic axial spondyloarthritis - severe, active in adults who have responded inadequately to conventional therapy
Subcutaneous injection

Further information

Yes
May 2021

Trial or other data

Nov 20PIII PREVENT RCT (n=555) found 52 weeks of treatment with secukinumab 150mg every 4 weeks was superior to placebo for 40% improvement in disease activity according to Assessment of Spondyloarthritis International Society criteria (39.8% vs 19.9% p<0.05). No new safety findings were reported [10].
Sep 19Positive new data from the ongoing PIII PREVENT trial. This 2 yr trial is evaluating the efficacy and safety of secukinumab in nr-axSpA. The trial has met its primary endpoint of ASAS40 (=improvement of at least 40% and of at least 10 units on a 0-100 scale in >3 of the following: patient global assessment, pain assessment, function, and inflammation.[6]
Apr 16PIII (NCT02696031) study to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with non-radiographic axial spondyloarthritis at Week 16 as well as week 52 and long term efficacy and safety up to Week 104 starts. 555 adults will be recruited from the US, Austria, France, Germany & the UK. Primary outcome is the proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria); collection of these data should complete Nov 19 [1].

Evidence based evaluations

CosentyxSevere chronic plaque psoriasis in children and adolescents aged 6-17 years old

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
August 2020
Oct 20Filed in US [8].
Aug 20Approved in EU [7]
Jun 20Recommended for EU approval by CHMP - the additional indication is "for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy [6].
Mar 20Currently pre-registration in EU. Has been filed using the centralised procedure [5].

Category

Interleukin-17A antagonist
It is estimated that approximately 30–50 % of adults with psoriasis developed psoriasis before 20 years of age [1]. A worldwide systematic review found that the prevalence of psoriasis in children ranged from 0% to 1.37% [2].
Severe chronic plaque psoriasis in children and adolescents aged 6-17 years old
Subcutaneous injection

Further information

Yes
October 2021

Trial or other data

Nov 19PIII study (NCT02471144) has completed; final data was collected Dec 2018 [4].
Jun 18PIII study (NCT02471144) is still recruiting [3].
Sep 15PIII study (NCT02471144) to assess efficacy and safety of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment, or failed to respond to or tolerate previous systemic treatment and/or UV therapy. 160 patients will be recruited from sites including the US and EU (incl. UK). Collection of primary outcome data is due to complete Nov 19 [3].

Evidence based evaluations

CosentyxPsoriatic arthritis - axial manifestations

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Launched
Phase III Clinical Trials
Mar 21EU approves use of Cosentyx to treat axial manifestations of PsA. The label update includes data from the PIIIb MAXIMISE trial [4].

Category

Fully human IgG1k anti-IL17A antibody
Prevalence of psoriatic arthritis varies from 20-420 per 100,000 population across the world. In about 80% of cases the presence of psoriasis precedes the onset of psoriatic arthritis [2].
Psoriatic arthritis - axial manifestations
Subcutaneous injection

Trial or other data

Jun 20Results from PIII MAXIMISE trial published on US trial registry [3].
Jun 19Novartis announce PIII MAXIMISE trial (NCT02721966) meets both primary and key secondary endpoints with 63.1% of secukinumab 300 mg and 66.3% of secukinumab 150 mg patients achieving ASAS20 at week 12 (vs 31.3% for placebo), respectively [1].

CosentyxJuvenile idiopathic arthritis and active enthesitis-related arthritis (ERA) in patients aged 2 to 18 years

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Interleukin-17A antagonist
Juvenile idiopathic arthritis has an annual incidence of 0.1 per 1,000 children in the UK (equivalent to 1,000 children diagnosed per year). Polyarthritis accounts for about 25% of new diagnosis [1].
Juvenile idiopathic arthritis and active enthesitis-related arthritis (ERA) in patients aged 2 to 18 years
Subcutaneous injection

Further information

Yes
To be confirmed

Trial or other data

Jan 20: PIII study (NCT03031782) is active but no longer recruiting. Primary completion date 22Oct19 [3].

Evidence based evaluations

CosentyxModerate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy

Information

Cosentyx
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Interleukin-17A antagonist
Hidradenitis suppurativa is a chronic persistent or recurrent suppurative disease of unknown cause occurring in the apocrine follicles, usually affecting the groin and axillae and also other apocrine-bearing sites such as the breasts, perineum and buttocks. Prevalence in Europe has been estimated to be in the region of 1% [1].
Moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy
Subcutaneous injection