Jun 20 · Approved in EU [18].

Jun 20 · Approved in US for treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) [17].

Apr 20 · Recommended 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 20 · According to company pipeline, ixekizumab is under regulatory review for non-radiographic AS; assume US only at this time [15].

Aug 19 · Approved in the US for ankylosing spondylitis (radiographic axial spondyloarthritis) [12].

Apr 19 · Following 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 18 · Filed in the US for radiographic axial spondyloarthritis [8].

1-2% of the UK population have spondyloarthritis which includes ankylosing spondylitis and psoriatic arthritis [1].

Dec 19 · Results 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 19 · In 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 19 · Topline 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 19 · Results 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 18 · Results 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 18 · Results 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 18 · Positive 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 18 · Ixekizumab 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 17 · Two 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 16 · PIII 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 16 · PIII 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].

NICE draft scope

NICE scope

NIHR

Jul 20 · Approved in the EU and UK [5].

May 20 · Recommended 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]

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].

7 July 2020 · EPAR