Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2

Marzo‐Ortega, Helena; Sieper, Joachim; Kivitz, Alan; Blanco, Ricardo; Cohen, Maxime C.; Delicha, Evie-Maria; Rohrer, Susanne; Richards, Hanno B.

doi:10.1136/rmdopen-2017-000592

Cited by 71 publications

(74 citation statements)

References 18 publications

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“…The safety profile of secukinumab remained favourable and was consistent with previous reports 1. 3 SAT0284 AN ADD-ON TRAINING PROGRAM INVOLVING BREATHING EXERCISES, COLD EXPOSURE, AND MEDITATION ATTENUATES INFLAMMATION AND DISEASE ACTIVITY IN AXIAL SPONDYLOARTHRITIS G.A.…”

supporting

confidence: 89%

SAT0283 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the phase iii trial, measure 2

Marzo‐Ortega¹,

Sieper²,

Kivitz

et al. 2018

Saturday, 16 JUNE 2018

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BackgroundSecukinumab, a fully human monoclonal antibody that neutralises IL-17A, has shown significant and sustained improvement in the signs and symptoms of active ankylosing spondylitis (AS) through 3 years in the MEASURE 2 study (NCT01649375).1 ObjectivesTo report the longer-term (4 year) efficacy and safety of subcutaneous (s.c.) secukinumab 150 mg in the MEASURE 2 study.MethodsAS patients (pts; n=219) were randomised to receive s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks (Wks) 1, 2 and 3 and every 4 weeks from Wk 4. At Wk 16, placebo-treated pts were re–randomised to receive secukinumab 150/75 mg. Efficacy results are reported for pts initially randomised to secukinumab 150 mg and those who switched from placebo to secukinumab 150 mg at Wk 16. Safety analyses included all pts who received ≥1 dose of secukinumab. Results are reported as observed.ResultsThe retention rate from Wk 16 to 208 was 85% (85/100) for secukinumab 150 mg. Sustained improvements were observed with secukinumab 150 mg across all endpoints through 4 years (Table). These improvements were maintained regardless of prior exposure to anti–TNF therapy; greater responses were demonstrated in anti–TNF-naïve pts. Over the entire study period, the mean exposure (±SD) to secukinumab was 1189.3±452.9 days. Exposure-adjusted incidence rates (per 100 pt-years) with any secukinumab dose for selected adverse events were: serious infections/infestations (1.5), Candida infections (1.2), Crohn’s disease (0.6), major adverse cardiovascular events (0.6), uveitis (0.6), and malignant/unspecified tumours (0.4).Abstract SAT0283 – Table 1Clinical improvements with secukinumab 150 mg at Weeks 52 and 208VariableWeekSecukinumab 150 mga TotalAnti–TNF-naïveAnti–TNF-IR ASAS20,% responders (n)5274.2 (93)80.0 (60)63.6 (33)20873.3 (86)74.6 (59)70.4 (27)ASAS40,% responders (n)5257.0 (93)63.3 (60)45.5 (33)20860.5 (86)62.7 (59)55.6 (27)BASDAI, mean change±SD (n)52−3.2±2.3 (93)−3.3±2.3 (60)−3.0±2.1 (33)208−3.2±2.3 (86)−3.5±2.4 (59)−2.7±2.0 (27)SF-36 PCS, mean change±SD (n)527.6±7.7 (94)8.0±7.5 (61)6.9±8.1 (33)2088.3±8.3 (85)9.4±8.5 (58)6.2±7.8 (27)ASAS partial remission,% responders (n)5224.7 (93)28.3 (60)18.2 (33)20827.9 (86)32.2 (59)18.5 (27)aIncludes placebo switchers. Data are reported as observed.ASAS; Assessment in SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; IR, inadequate response; SD, standard deviation; SF-36 PCS, Short Form36 Health Survey Physical Component Summary; TNF, tumour necrosis factorConclusionsSecukinumab 150 mg provided sustained improvement in the signs, symptoms and physical function in pts with AS through 4 years of treatment with 85% retention rate. The safety profile of secukinumab remained favourable and was consistent with previous reports.1–3 References[1] Marzo-Ortega, et al. RMD Open2017;3:e000592.[2] Marzo-Ortega, et al. Ann Rheum Dis2016;75:812–3.[3] Baraliakos, et al. Clin Exp Rheumatol2017.Disclosure of InterestH. Marzo-Ortega Grant/research support from: Janssen, Cel...

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supporting

confidence: 89%

SAT0283 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the phase iii trial, measure 2

Marzo‐Ortega¹,

Sieper²,

Kivitz

et al. 2018

Saturday, 16 JUNE 2018

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“…For example, ASAS20 response rates (both as observed and with multiple imputations, where reported) remained high (68–80%) over 3–5 years of treatment [18–20, 33–35]. …”

Section: Therapeutic Efficacy Of Secukinumabmentioning

confidence: 99%

Secukinumab: A Review in Ankylosing Spondylitis

Blair

2019

Drugs

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Secukinumab (Cosentyx®), a first-in-class fully human monoclonal antibody against interleukin-17A, is approved in several countries, including the USA and those of the EU, for the treatment of ankylosing spondylitis (AS). Subcutaneous secukinumab significantly improved the clinical signs and symptoms of AS versus placebo in three of four phase III trials. The benefits of secukinumab were generally seen regardless of whether patients had or had not received previous tumour necrosis factor (TNF) inhibitor therapy, and were sustained during longer-term (up to 5 years) treatment. Secukinumab was also associated with improvements in spinal mobility, physical function, health-related quality of life and work productivity in some of the trials. In MEASURE 1, secukinumab reduced inflammation in the sacroiliac joint, and slowed radiographic progression. Secukinumab was generally well tolerated during up to 5 years’ treatment; the most commonly reported adverse event was nasopharyngitis. In the minority of patients who developed anti-drug antibodies (ADAs), ADAs did not decrease efficacy or increase adverse events. In conclusion, secukinumab is an effective therapy for TNF inhibitor-naive patients with active AS, and provides a useful treatment option for patients who have an inadequate response to or are intolerant of TNF inhibitors.

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“…For the literature review, we initially chose 10 out of 313 papers in PubMed for full text review and selected 5 for final inclusion . Three of them were related to the MEASUER 2 clinical trial (secukinumab 150 mg, NCT01649375) and 2 were related to the ATLAS clinical trial (adalimumab 40 mg, NCT00085644) with long‐term follow‐up data. The flow diagram of this systematic review is described in Figure .…”

Section: Resultsmentioning

confidence: 99%

“…We used the ASAS 20 and ASAS 40 from the selected studies to identify the response rate of secukinumab and adalimumab (Table ). Since only a subcutaneous loading regimen of secukinumab is approved in Korea, we used MEASURE 2 trial data which included a subcutaneous loading regimen for secukinumab administration . ASAS 20 and ASAS 40 at short times (16 weeks for secukinumab and 12 weeks for adalimumab) were compared directly not adjusting for other patient characteristics and study design.…”

Section: Methodsmentioning

confidence: 99%

A cost per responder analysis of secukinumab vs adalimumab for the treatment of ankylosing spondylitis from the Korean perspective

Kim

Cho

et al. 2019

Int J of Rheum Dis

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Aim To compare the cost‐effectiveness of secukinumab vs adalimumab at 1 and 2 years of treatment in patients with ankylosing spondylitis (AS) by analyzing the cost per responder reported in randomized controlled trials (RCTs) from the Korean perspective. Method A systematic literature search was performed via PubMed for relevant RCTs for comparing the response rate in patients with AS. The response rates in anti‐tumor necrosis factor‐naive subjects were extracted from RCTs and cost per responder analyses were calculated in case of both with or without a loading dosage of secukinumab compared with adalimumab. Results The Assessment in AS International Working Group (ASAS) 20 and 40 response rates of secukinumab from the MEASURE 2 trial and those of adalimumab from the ATLAS trial were comparable. The cost per ASAS 20 responder was lower by 40% in secukinumab compared to adalimumab: USD9637 vs 16 129 at 52 weeks and USD20 051 vs 32 699 at 104 weeks for secukinumab (in maintenance dosing) vs adalimumab, respectively. The cost per ASAS 40 responder was also lower by 40% in secukinumab: USD12 179 vs 22 395 at 52 weeks and USD27 338 vs 41 655 at 104 weeks for secukinumab vs adalimumab, respectively. With a loading dosage of secukinumab at 52 and 104 weeks, secukinumab showed lower costs per responder by 25% compared to adalimumab. Conclusion The costs per responder associated with ASAS 20 and 40 response rates were consistently lower for secukinumab compared with adalimumab. The treatment with secukinumab for patients with AS could be a cost‐saving treatment option in South Korea.

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Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2

Cited by 71 publications

References 18 publications

SAT0283 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the phase iii trial, measure 2

SAT0283 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the phase iii trial, measure 2

Secukinumab: A Review in Ankylosing Spondylitis

A cost per responder analysis of secukinumab vs adalimumab for the treatment of ankylosing spondylitis from the Korean perspective

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