5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial

Marzo‐Ortega, Helena; Sieper, Joachim; Kivitz, Alan; Blanco, Ricardo; Cohen, Maxime C.; Pavelka, Karel; Delicha, Eumorphia Maria; Stefańska, Anna; Richards, Hanno B.; Rohrer, Susanne

doi:10.1016/s2665-9913(20)30066-7

Cited by 20 publications

(32 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“… 35 The primary endpoint of MEASURE 2 was met, with significantly higher proportions of patients achieving ASAS20 versus placebo; improvements were sustained through to 5 years ( Figure 1 ). 23 , 36 …”

Section: Secukinumabmentioning

confidence: 99%

Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence

Braun

Kiltz

Bühring

et al. 2021

Therapeutic Advances in Musculoskeletal

View full text Add to dashboard Cite

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease characterized by inflammation and new bone formation in the axial skeleton. AxSpA is considered a spectrum of disease that includes two subtypes identified by the Assessment in SpondyloArthritis International Society classification criteria, namely, radiographic (r-axSpA usually referred to as ankylosing spondylitis) and non-radiographic axSpA (nr-axSpA). Although the burden of disease appears similar between the two classified subtypes, the degree of inflammation, as assessed by magnetic resonance imaging and C-reactive protein, and the degree of new bone formation are significantly higher in r-axSpA than in nr-axSpA. Nevertheless, axSpA is considered one disease with different courses. International guidelines for the management of axSpA have outlined treatment goals focused on control of signs and symptoms, inflammation, prevention of progressive structural damage, preservation of physical function, normalization of social participation and improvement of quality of life. The pathogenesis of axSpA has not been completely elucidated to date. A strong link between human leukocyte antigen B27 and axSpA, however, has been identified, and the success of anti-tumour necrosis factor and anti-interleukin (IL)-17A therapy has highlighted some of the key pro-inflammatory cytokines involved. The anti-IL-17A monoclonal antibody secukinumab is approved for the treatment of ankylosing spondylitis and nr-axSpA in the European Union and United States. In this narrative review, we discuss data for secukinumab in axSpA from randomized controlled trials, including MEASURE trials in AS and PREVENT in nr-axSpA, and real-world evidence.

show abstract

Section: Secukinumabmentioning

confidence: 99%

Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence

Braun

Kiltz

Bühring

et al. 2021

Therapeutic Advances in Musculoskeletal

View full text Add to dashboard Cite

show abstract

“…Secukinumab, a human monoclonal antibody that directly inhibits IL-17A, demonstrated sustained efficacy in patients with active AS in the pivotal Phase III MEASURE 1 and 2 studies over 5 years and had a consistent safety profile with long-term therapy. [ 13 – 17 ] In a pooled analysis from the MEASURE 1 and 2 studies, secukinumab 150 mg demonstrated sustained efficacy and consistent safety in Asian patients with AS through 52 weeks. [ 18 ] Specifically, in a cohort of patients with active AS in the MEASURE 1 extension trial, secukinumab 150 mg demonstrated sustained efficacy and consistent safety over 4 years.…”

Section: Introductionmentioning

confidence: 99%

Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5

Huang

Sun

Wan

et al. 2020

Chinese Medical Journal

View full text Add to dashboard Cite

Background Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study. Methods MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs . non-China). Results Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% ( P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52. Conclusions Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations. Trial registration ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1 .

show abstract

“…Sustained responses were observed in the 5-year, long-term extension of MEASURE 1, during which 74% of the patients in the 75 mg group and 79% of those in the 150 mg group achieved an ASAS20 response, and respectively 54% and 65% achieved an ASAS40 response. 109 , 110 Among the 150 patients who completed five years’ treatment with SEC 150 mg in the extension of MEASURE 2, 111 ASAS20 responses were recorded in 67% and ASAS40 responses in 50%, and there were sustained improvements in the other efficacy endpoints. The drug’s safety profile remained consistent with that described in previous reports.…”

Section: Il-17 Inhibition In Axspa Patients: Randomised Controlled Trials and Real-life Datamentioning

confidence: 99%

“…The drug's safety profile remained consistent with that described in previous reports. 111 A pooled analysis of MEASURE 1 and 2 showed that the majority of the SEC-treated patients who achieved remission by week 16 remained in remission for up to three years. 112 The use of SEC 150 mg in the MEASURE 2-J trial led to sustained improvement in the signs and symptoms of Japanese AS patients for 24 weeks without giving rise to any new or unexpected safety issues.…”

Section: Dovepressmentioning

confidence: 99%

“…Treatment emergent anterior uveitis and IBD were reported in long-term clinical trials (MEASURE and COAST programs) and post marketing safety data in psoriasis, PsA and AS with low overall incidences, within the expected ranges in these disorders. 110 , 111 , 134 , 138 However, the available data, although limited, would encourage caution in the use of IL-17 inhibition in patients with a history of uveitis or IBD.…”

Section: Il-17 Inhibition In Axspa Patients: Randomised Controlled Trials and Real-life Datamentioning

confidence: 99%

See 1 more Smart Citation

Anti-IL-17 Agents in the Treatment of Axial Spondyloarthritis

Atzeni

Carriero

Boccassini

et al. 2021

ITT

View full text Add to dashboard Cite

Axial spondyloarthritis (axSpA) describes a group of chronic inflammatory rheumatic diseases primarily involving the axial skeleton. IL-17 is involved in the pathogenesis of numerous inflammatory diseases, including inflammatory arthritis. Until a few years ago, the only biological agents licensed for the treatment of axSpA and nr-axSpA were TNF inhibitors. However, as some patients did not respond to TNF inhibition or experienced secondary failure, the introduction of the first two IL-17 inhibitors (secukinumab [SEC] and ixekizumab [IXE]) has extended the treatment options, and there are now three others (bimekizumab, brodalumab and netakimab) in various stages of clinical development. The last ten years have seen the development of a number of therapeutic recommendations that aimed at improving the management of axSpA patients. The aim of this narrative review of the published literature concerning the role of IL-17 in the pathogenesis of SpA, and the role of IL-17 inhibitors in the treatment of axSpA, is to provide a comprehensive picture of the clinical efficacy and safety of the drugs themselves, and the treatment strategies recommended in the international guidelines.

show abstract

5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial

Cited by 20 publications

References 22 publications

Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence

Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence

Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5

Anti-IL-17 Agents in the Treatment of Axial Spondyloarthritis

Contact Info

Product

Resources

About