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  • Taltz showed consistent, long-term improvement in ...

Taltz showed consistent, long-term improvement in key signs and symptoms of axial spondyloarthritis through two years in phase III study.- Eli Lilly.

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Published:3rd Jun 2021
Eli Lilly and Company will present new data from Phase III studies that further demonstrated the long-term efficacy and safety profile of Taltz (ixekizumab) among patients with axial spondyloarthritis (axSpA).

These results are being presented at the virtual Annual European Congress of Rheumatology (EULAR), June 2-5, 2021. AxSpA is recognized as a single disease entity, with two subtypes which are defined depending on the presence (radiographic axSpA, or r-axSpA) or absence (non-radiographic axSpA, or nr-axSpA) of defined structural damage of the sacroiliac joints on plain x-ray films as per the modified New York (mNY) criteria. Taltz Showed Sustained Long-Term Improvements in axSpA Through Two Years : In COAST-Y, Taltz showed consistent and sustained long-term improvements in signs and symptoms, functionality and quality of life in patients with r- and nr-axSpA. In this study, more than half of patients (56.7%) treated continuously with Taltz (80 mg every four weeks, n=157) through two years achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40).Among those treated continuously with Taltz every four weeks for two years: i. 43.9% of patients achieved low disease activity status, as measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1. mean change from baseline (3.9) in asdas score was -1.6. ii. 19.7% achieved asas partial remission status. iii. mean change from baseline (6.6) in bath ankylosing spondylitis functional index (basfi) was -2.8. iv. mean change from baseline (33.9) in medical outcomes survey short form 36 physical component summary (sf-36 pcs) was 8.4. v. the safety profile of taltz was consistent with previously published safety data, and no new safety signals were observed after up to two years of treatment. additional results from the phase iii coast-y study were also recently published in the annals of the rheumatic diseases. most patients treated with taltz did not show bone damage progression of r-axspa up to two years.; an analysis of two phase iii studies in r-axspa (coast-v and coast-w) and the long-term extension trial (coast-y), found that 9 out of 10 patients treated with taltz (89.6%, n="206)" did not show radiographic progression for up to two years, as measured by mean change from baseline of modified stoke ankylosing spondylitis spinal score (msasss)><2. overall mean rates of progression were low among patients treated with taltz. these results were similar among patients who were previously treated with anti-tnf therapy (88%, n="106)" and those who had not previously been treated with a biologic (91%, n="100)." notably, lilly will also present new analyses in axspa and psoriatic arthritis , including the following: i. baseline characteristics and treatment response to ixekizumab categorized by sex in radiographic and non-radiographic axial spondyloarthritis patients through 52 weeks: data from 3 phase iii randomized controlled trials. ii. ixekizumab shows a distinct pattern of pain improvement beyond inflammation in radiographic axial spondyloarthritis. iii. ixekizumab efficacy on spinal pain, disease activity and quality of life in patients with psoriatic arthritis presenting with symptoms suggestive of axial involvement. more than 175,000 patients have been treated with taltz worldwide since launch, giving healthcare providers confidence in making informed prescribing decisions for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, active nr-axspa and moderate to severe plaque psoriasis. methodology:about the analyses :long-term treatment with ixekizumab in patients with axial spondyloarthritis: 2-year results from coast-y : i. coast-y is the two-year extension of the coast-v, coast-w and coast-x trials. upon completion of the initial trials, 773 patients continued with the dose received at the end of the originating trial at week 52, either with 80 mg taltz every two weeks or four weeks. patients who had been assigned to adalimumab or placebo were re-randomized to taltz every two weeks or every four weeks at week 16 in coast-v and coast-w. patients who had received placebo for 52 weeks in coast-x were switched to taltz every four weeks in coast-y. for this analysis, only patients continuously treated with taltz since the originating studies were included. all other patients were analyzed separately. ii.standardized efficacy measures were used. missing data were handled by non-responder imputation for categorical data and modified baseline observation carried forward for continuous data. safety data were analyzed for all patients who received greater than 1 dose of taltz. evaluation of spinal radiographic progression in patients with radiographic axial spondyloarthritis receiving ixekizumab therapy over 2 years : i. these analyses included biologic-naïve patients with active r-axspa (coast-v) or patients with prior inadequate response or intolerance to one or two tnf inhibitors (coast-w) who received 80 mg taltz every two weeks or four weeks for two years (108 weeks, of which 56 weeks were the coast-y long-term extension study).ii. mean change from baseline of msasss (average score from two selected readers, blinded for time order) for patients treated with taltz for two years with data at both baseline and year 2 is presented (n="230;" 54% of total randomized patients). of the 657 patients who entered coast-v or -w, 527 patients re-consented to enter coast-y; however, 104 patients had either baseline or year 2 msasss data missing. of 423 patients with baseline and year 2 msasss data, 230 (54%) were treated with taltz for at least two years. of these, 110 were biologic-naïve and 120 were tnfi-experienced. see-"continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (coast-y)": -robert bm landewé, lianne s gensler,denis poddubnyy, proton rahman, et al., behalf of the coast-y study group.http: 0000-0002-3561-5932.></2.></2.1.>

Condition: Axial Spondyloarthritis
Type: drug

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