Ixekizumab

Refrigerated StorageNew Medicines ·
32819111000001107

Refrigerated Storage

TaltzEli Lilly

Eli Lilly
Taltz
80mg/ml solution for injection in pre-filled syringe or pen

In the event of an inadvertent temperature excursion the following data may be used:
Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 °C by the end user.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Information not provided by the manufacturer
Information not provided by the manufacturer
21 May 2019
London MI service

New Medicines

TaltzRadiographic and non-radiographic axial spondyloarthritis, in biological DMARD-naive or TNF-inhibitor-experienced adults

Information

Taltz
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Launched
Launched
Launched
June 2020
Jun 20Approved in EU [18].
Jun 20Approved in US for treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) [17].
Apr 20Recommended for EU approval by CHMP - the additional indication is "Axial spondyloarthritis. Ankylosing spondylitis (radiographic axial spondyloarthritis): for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis: for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs)" [16].
Jan 20According to company pipeline, ixekizumab is under regulatory review for non-radiographic AS; assume US only at this time [15].
Aug 19Approved in the US for ankylosing spondylitis (radiographic axial spondyloarthritis) [12].
Apr 19Following positive data from the PIII COAST-X trial, Lilly announce plans to submit to regulatory authorities for non-radiographic axial spondyloarthritis later in 2019 [11].
Dec 18Filed in the US for radiographic axial spondyloarthritis [8].

Category

Humanized anti–interleukin-17 monoclonal antibody
1-2% of the UK population have spondyloarthritis which includes ankylosing spondylitis and psoriatic arthritis [1].
Radiographic and non-radiographic axial spondyloarthritis, in biological DMARD-naive or TNF-inhibitor-experienced adults
Subcutaneous

Further information

Yes
May 2021

Trial or other data

Dec 19Results of COAST-X trial (NCT02757352) published in The Lancet; the RCT (n=303) found ixekizumab was superior to placebo for improving symptoms of disease at 52 weeks; 30% of patients in the ixekizumab every 4 weeks group (p=0.0045); 31% of the ixekizumab every 2 weeks group (p=0.0037) vs. 13% of patients in placebo group [14].
Nov 19In PIII COAST-X trial, 35% and 40% of patients given ixekizumab every 4 weeks and 2 weeks respectively achieved ASAS40 response vs 19% with placebo. The safety profile of ixekizumab was consistent with previously reported results [13].
Apr 19Topline results from PIII COAST-X trial of ixekizumab in nr-axSpA in pts who had no previous disease-modifying anti-rheumatic drug (bDMARD) treatment. Ixekizumab met the primary endpoint at weeks 16 and 52 with a statistically significant improvement in the signs and symptoms of nr-axSpA based on proportion of pts who hit Assessment of Spondyloarthritis International Society 40 (ASAS40) response vs. placebo. It also met the secondary endpoints, including improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of pts achieving low disease activity, significant improvement in sacroiliac joint inflammation assessed by MRI and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [10].
Mar 19Results of COAST-W (n=316) are published. The study found that more ixekizumab- treated patients achieved an ASAS40 response (40% improvement in Assessment of SpondyloArthritis international Society criteria) vs placebo (2 weekly dosing 30.6%; 4 weekly dosing; 25.4%; placebo 12.5%; p<0.01) but with more adverse events [9].
Oct 18Results form COAST-W announced at conference. RCT (n=316 with inadequate response/intolerance to 1 or 2 TNF inhibitors) reported that following 80 mg or 160 mg starting dose at Week 0, 25% patients treated with 80mg four weekly, 31% on 80mg 2-weekly and 13% on placebo achieved ASAS40 at 16 weeks (primary endpoint) [8].
Oct 18Results of PIII COAST-V study published in The Lancet. RCT (n=341) found at week 16, more patients achieved ASAS40 with ixekizumab (IX) 2-weekly (43 [52%]; p<0·0001), 4-weekly (39 [48%]; p<0·0001), and adalimumab (32 [36%]; p=0·0053) compared with placebo (16 [18%]). Safety profile was consistent with previous indications of IX [7].
Jun 18Positive topline results of the PIII COAST-W study announced. Ixekizumab showed a statistically significant improvement in the symptoms of AS, measured by the proportion of pts who achieved ASAS40 response at 16 weeks vs. placebo [6].
Feb 18Ixekizumab met the primary and all key secondary endpoints in the PIII COAST-V study(NCT02696785). The incidence of adverse events was comparable to placebo and consistent with the PIII studies of ixekizumab for plaque psoriasis and psoriatic arthritis [5].
Nov 17Two further trials are underway - COAST-X (non-radiographic; NCT02757352) and COAST-Y (radiographic and non-radiographic; NCT03129100). COAST-X is due to finish Q3 18, and COAST-Y Q1 21 [4].
Apr 16PIII COAST-W study (NCT02696798) has started and aims to evaluate efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA). Primary outcome is proportion of participants achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response. The randomised, double-blind trial will enrol approximately 300 participants. Enrolment is underway in the US, UK, Netherlands, Argentina, Brazil, Finland, France, South Korea, Mexico, Poland, Puerto Rico, Spain and is expected to expand to Canada, Germany, Israel and Italy and collection of data should complete Jun 17 [2,3].
Apr 16PIII COAST-V study (NCT02696785) is due to start to evaluate safety and efficacy of ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with rad-axSpA. Primary outcome is proportion of participants achieving an ASAS40 response, & collection of these data should complete Jun 17. The randomised, double-blind trial is recruiting 320 participants in the US, the Czech Republic, Hungary, Japan, South Korea, Mexico, the Netherlands, Taiwan and Poland, and will extend to Canada, Germany, Italy and Russia [2,3].

Evidence based evaluations

TaltzModerate to severe chronic plaque psoriasis in children aged 6-17 years

Information

Taltz
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
July 2020
Jul 20Approved in the EU and UK [5].
May 20Recommended for EU approval by CHMP - the additional indication is "for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy." [4]

Category

Humanized anti–interleukin-17 monoclonal antibody
Prevalence of psoriasis in childhood in the UK is about 0.55 % in children aged 0–9 years and 1.37 % in children aged 10–19 years [1].
Moderate to severe chronic plaque psoriasis in children aged 6-17 years
Subcutaneous injection

Evidence based evaluations

7 July 2020EPAR