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Secukinumab Efficacy in Anti-TNF-Naive and Anti-TNF Downloaded from http://ard.bmj.com/ on October 7, 2016 - Published by group.bmj.com ARD Online First, published on August 31, 2016 as 10.1136/annrheumdis-2016-210023 Clinical and epidemiological research CONCISE REPORT Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: results from the MEASURE 2 Study Joachim Sieper,1 Atul Deodhar,2 Helena Marzo-Ortega,3 Jacob A Aelion,4 Ricardo Blanco,5 Tseng Jui-Cheng,6 Mats Andersson,7 Brian Porter,8 Hanno B Richards,7 on behalf of the MEASURE 2 Study Group Handling editor Tore K Kvien ABSTRACT intolerant to these agents or fail to achieve 56 ▸ Additional material is Background There is significant unmet need in adequate disease control. published online only. To view patients with ankylosing spondylitis (AS) who have Treatment with secukinumab (human anti- please visit the journal online inadequate response or intolerance to anti-tumour interleukin (IL)-17A IgG1k monoclonal antibody) (http://dx.doi.org/10.1136/ fi annrheumdis-2016-210023). necrosis factor (TNF) treatment. Secukinumab, an anti- signi cantly improved the signs and symptoms of AS interleukin-17A monoclonal antibody, significantly when compared with placebo treatment in two phase fi For numbered af liations see improved signs and symptoms of AS in the MEASURE 2 3 trials (MEASURE 1 (intravenous followed by sub- end of article. study (NCT01649375). cutaneous (s.c.) administration; NCT01358175) and 7 Correspondence to Methods Subjects with active AS (N=219) received MEASURE 2 (s.c. administration; NCT01649375)). Professor Joachim Sieper, secukinumab (150 or 75 mg) or placebo at baseline, In MEASURE 2, 61% and 41% of subjects treated Medical Department weeks 1, 2, 3 and 4, and every 4 weeks thereafter. with secukinumab 150 mg and 75 mg, respectively, I, Rheumatology, Campus fi Benjamin Franklin, Charité Randomisation was strati ed by prior anti-TNF use: anti- achieved an Assessment of SpondyloArthritis Universitätsmedizin Berlin, TNF-naive or inadequate response/intolerance to one International Society 20 (ASAS20) response at week Hindenburgdamm 30, anti-TNF (anti-TNF-IR). The primary endpoint was 16, compared with 28% given placebo.7 All pre- Berlin 12203, Germany; Assessment of SpondyloArthritis International Society defined secondary endpoints except ASAS partial [email protected] criteria (ASAS) 20 at week 16. remission were met with secukinumab 150 mg s.c. Received 6 June 2016 Results At week 16, 68.2% of anti-TNF-naive subjects The clinical responses observed at week 16 were sus- 7 Revised 3 August 2016 treated with secukinumab 150 mg achieved ASAS20 tained through 52 weeks of therapy. Responses with Accepted 9 August 2016 compared with 31.1% treated with placebo (p<0.001). secukinumab 75 mg were not significantly different In the anti-TNF-IR group, 50.0% of subjects treated with from placebo for the primary endpoint or for sec- secukinumab 150 mg achieved an ASAS20 response ondary endpoints based on hierarchical testing.7 The compared with 24.1% treated with placebo (p<0.05). safety profile was consistent with other studies of Numerically greater improvements were observed with secukinumab in AS, psoriatic arthritis and moderate- – secukinumab than with placebo for most secondary to-severe plaque psoriasis.7 11 endpoints. Clinical responses were sustained through Here, we present the results of a pre-specified week 52. subgroup analysis of MEASURE 2 to investigate the Conclusions Secukinumab 150 mg provided sustained efficacy of secukinumab in subjects who were naive improvements in signs and symptoms of AS in anti-TNF- to anti-TNF therapy (anti-TNF-naive) and in those naive and anti-TNF-IR subjects through 52 weeks of with a history of inadequate response or reported therapy. intolerance to anti-TNF therapy (anti-TNF-IR). Trial registration number NCT01649375. PATIENTS AND METHODS MEASURE 2 is an ongoing randomised, double- blind, placebo-controlled, 5-year, phase 3 trial. A INTRODUCTION complete description of enrolment criteria, study Ankylosing spondylitis (AS) is a chronic inflamma- procedures and study design has been reported tory disease which primarily affects the axial skel- previously.7 eton.1 It is characterised by the erosion and fusion Eligible subjects were aged ≥18 years with AS of the spinal vertebrae and sacroiliac joints,2 which fulfilling the modified New York criteria, a score often results in progressive, irreversible structural of ≥4(0–10) on the Bath AS Disease Activity damage, deterioration of function, disability and Index (BASDAI), and a spinal pain score of reduced quality of life (QoL).34 ≥40 mm on a 100 mm visual analogue scale, Current therapeutic options are limited for despite treatment with their maximum tolerated To cite: Sieper J, patients with AS. Non-steroidal anti-inflammatory dose of non-steroidal anti-inflammatory drugs Deodhar A, Marzo-Ortega H, drugs are often insufficient to control disease symp- (NSAIDs). Written informed consent was obtained et al. Ann Rheum Dis Published Online First: toms and, although anti-tumour necrosis factor from all subjects. [please include Day Month (TNF) therapy is recommended for patients with Subjects previously treated with only one Year] doi:10.1136/ persistent disease activity despite conventional anti-TNF agent were eligible to participate in the annrheumdis-2016-210023 treatment, up to 40% of patients with AS become study if they had had an inadequate response after Sieper J, et al. Ann Rheum Dis 2016;0:1–5. doi:10.1136/annrheumdis-2016-210023 1 Copyright Article author (or their employer) 2016. Produced by BMJ Publishing Group Ltd (& EULAR) under licence. Downloaded from http://ard.bmj.com/ on October 7, 2016 - Published by group.bmj.com Clinical and epidemiological research receiving the approved dose for ≥3 months or were unable to Missing response values, including those due to discontinuation, tolerate at least one dose (anti-TNF-IR). The online were imputed as non-response (non-responder imputation Supplementary Methods file provides further information (NRI)). A mixed-effects model (MMRM) was used to analyse regarding allowed medication and exclusion criteria. continuous variables. Data are presented by NRI/MMRM and Subjects with active AS were randomised 1:1:1 to secukinu- observed analyses at week 52. Further information is provided mab 150 mg, secukinumab 75 mg or placebo, administered at in the online Supplementary Methods file. baseline, weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Randomisation was stratified by anti-TNF history: RESULTS anti-TNF-naive, or inadequate response or intolerance to one Subjects (N=219) were randomly assigned to treatment with previous anti-TNF agent (anti-TNF-IR). s.c. secukinumab 150 mg (n=72), secukinumab 75 mg (n=73) The primary efficacy endpoint was the proportion of subjects or placebo (n=74) from 28 October 2012 through 29 July achieving an ASAS20 response (improvement of ≥20% and ≥1 2013. Of 219 randomised subjects, 61.2% were anti-TNF-naive unit on a 10-unit scale in at least three of the four core ASAS and 38.8% were anti-TNF-IR. Demographic and baseline domains, with no worsening of ≥20% and ≥1 unit in the fourth) characteristics were similar across the subgroups (table 1) with at week 16. Secondary endpoints at week 16 are described in the fewer female patients in the anti-TNF-naive placebo group than online Supplementary Methods file. Exploratory endpoints in the respective secukinumab groups. Characteristics were com- included efficacy assessments through week 52. parable to the overall study population.7 At week 16, 200 Primary and secondary efficacy endpoint analyses included all (91.3%) subjects remained in the study and 181 (82.6%) subjects according to treatment assigned at randomisation. subjects completed 52 weeks of treatment. Efficacy analyses in anti-TNF-naive and anti-TNF-IR subgroups At week 16, a higher proportion of subjects treated with secu- were pre-specified. kinumab 150 mg achieved ASAS20 responses in both Logistic regression with treatment regimen and anti-TNF anti-TNF-naive and anti-TNF-IR subgroups than in the placebo status as factors, and weight as a covariate, was used to evaluate group (table 2 and figure 1). In the anti-TNF-naive group, 68.2% the effect of secukinumab versus placebo for binary variables. of subjects treated with secukinumab 150 mg achieved ASAS20 Table 1 Demographic and baseline characteristics Anti-TNF-naive Anti-TNF-IR Secukinumab s.c. Secukinumab s.c. 150 mg 75 mg Placebo 150 mg 75 mg Placebo (N=44) (N=45) (N=45) (N=28) (N=28) (N=29) Age (years), mean (SD) 43.7 (12.9) 43.9 (14.1) 43.5 (13.3) 39.3 (11.6) 45.2 (11.3) 43.8 (13.2) Female, n (%) 18 (40.9) 14 (31.1) 10 (22.2) 8 (28.6) 8 (28.6) 8 (27.6) Race, n (%) White 44 (100) 42 (93.3) 41 (91.1) 25 (89.3) 28 (100) 29 (100) Asian 0 3 (6.7) 4 (8.9) 2 (7.1) 0 0 American Indian or Alaskan Native 0 0 0 1 (3.6) 0 0 Ethnicity, n (%) Hispanic/Latino 0 3 (6.7) 3 (6.7) 5 (17.9) 3 (10.7) 5 (17.2) Not Hispanic/Latino 40 (90.9) 38 (84.4) 36 (80.0) 19 (67.9) 21 (75.0) 21 (72.4) Unknown or not reported 4 (9.1) 4 (8.9) 6 (13.3) 4 (14.3) 4 (14.3) 3 (10.3) Weight (kg), mean (SD) 80.4 (16.8) 80.0 (18.3) 81.8 (14.1) 85.4 (19.6) 83.8 (15.9) 77.9 (16.7) BMI (kg/m2), mean (SD) 27.0 (6.0) 27.7 (6.2) 27.4 (6.2) 28.1 (5.5) 28.6 (5.4) 26.5 (4.9) Time since AS diagnosis (years), mean (SD) 6.1 (8.6) 3.7 (5.7) 3.9 (6.2) 8.5 (7.6) 7.7 (9.0) 10.2 (11.0) Disease activity BASDAI, mean total score (SD) 6.7 (1.4) 6.4 (1.3) 6.8 (1.3) 6.5 (1.7) 6.8 (1.2) 6.7 (1.3) Total back pain
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