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Short-Term Efficacy and Safety of Secukinumab for Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of RCTs.

ABSTRACT: Secukinumab is a novel IL-17A inhibitor that has been confirmed to be effective for treating PsA and RA. Several studies have demonstrated that secukinumab also provides benefits for AS patients. Thus, we performed a meta-analysis of RCTs to evaluate the short-term efficacy and safety of secukinumab for the management of AS. The PubMed, Medline, Embase, Web of Science, and Cochrane Library databases were searched for RCTs published prior to March 2020 on the treatment of AS with secukinumab. The primary outcome was the ASAS20 response, and the secondary outcomes included the ASAS40 response, ASAS5/6 response, SF-36 PCS score, ASQoL score, and AEs. Dichotomous data were expressed as pooled RRs with 95% CIs, while continuous data were expressed as pooled MDs with 95% CIs. Subgroup analysis was conducted based on whether the AS patients previously underwent treatment with TNFi. A total of 4 RCTs with 1166 patients were included in our meta-analysis. At week 16, secukinumab 150?mg yielded significant improvements in the clinical response and patient-reported outcomes for AS patients. There was no increased risk of AEs. Consistent results were detected in the meta-analysis of secukinumab 75?mg versus a placebo. Furthermore, no significant difference was detected between the secukinumab 75?mg group and secukinumab 150?mg group. We concluded that secukinumab is effective for treating AS and generally well tolerated by AS patients in the short term, regardless of whether they previously underwent TNFi treatment. The superiority of secukinumab 150?mg over secukinumab 75?mg seems to be limited, since no significant difference in any endpoint was detected between the two groups.

SUBMITTER: Zhou Y

PROVIDER: S-EPMC7641709 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Short-Term Efficacy and Safety of Secukinumab for Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of RCTs.

Zhou Yu Y Ma Jinhui J Ge Juncheng J Wang Bailiang B Yue Debo D Wang Weiguo W

Mediators of inflammation 20201026

Secukinumab is a novel IL-17A inhibitor that has been confirmed to be effective for treating PsA and RA. Several studies have demonstrated that secukinumab also provides benefits for AS patients. Thus, we performed a meta-analysis of RCTs to evaluate the short-term efficacy and safety of secukinumab for the management of AS. The PubMed, Medline, Embase, Web of Science, and Cochrane Library databases were searched for RCTs published prior to March 2020 on the treatment of AS with secukinumab. The ...[more]

PMID: 33192173

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Project description:BACKGROUND:Secukinumab, an anti-interleukin-17A monoclonal antibody, improved the signs and symptoms of ankylosing spondylitis (AS) in two phase 3 studies (MEASURE 1 and MEASURE 2). Here, we present 52-week results from the MEASURE 3 study assessing the efficacy and safety of secukinumab 300 and 150 mg subcutaneous maintenance dosing, following an intravenous loading regimen. METHODS:A total of 226 patients were randomized to intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 300 mg (IV-300 mg) or 150 mg (IV-150 mg) every 4 weeks, or matched placebo. Patients in the placebo group were re-randomized to subcutaneous secukinumab at a dose of 300 or 150 mg at week 16. The primary endpoint was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16 in the IV-300 mg or IV-150 mg versus placebo. Other endpoints assessed through week 52 included improvements in ASAS40, ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity Index, and ASAS partial remission responses, as well as the change from baseline in high-sensitivity C-reactive protein levels. Statistical analyses followed a predefined hierarchical hypothesis testing strategy to adjust for multiplicity of testing, with non-responder imputation used for binary variables and mixed-model repeated measures for continuous variables. RESULTS:The primary efficacy endpoint was met; the ASAS20 response rate was significantly greater at week 16 in the IV-300 mg (60.5%; P?<?0.01) and IV-150 mg (58.1%; P?<?0.05) groups versus placebo (36.8%). All secondary endpoints were met at week 16, except ASAS partial remission in the IV-150 mg group. Improvements achieved with secukinumab in all clinical endpoints at week 16 were also sustained at week 52. Infections, including candidiasis, were more common with secukinumab than with placebo during the placebo-controlled period. During the entire treatment period, pooled incidence rates of Candida infections and grade 3-4 neutropenia were 1.8% for both of these adverse events in secukinumab-treated patients. CONCLUSIONS:Secukinumab (300 mg and 150 mg dose groups) provided rapid, significant and sustained improvement through 52 weeks in the signs and symptoms of patients with AS. The safety profile was consistent with previous reports, with no new or unexpected findings. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02008916 . Registered on 8 December 2013. EUDRACT 2013-001090-24. Registered on 24 October 2013). The study was not retrospectively registered.

Project description:ObjectivesTo systematically evaluate the efficacy and safety of sinomenine preparation (SP) for treating ankylosing spondylitis (AS).MethodsClinical randomized controlled trials (RCTs) of SP for treating AS were systematically identified in six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wanfang Databases from the inception up to 31 October 2019. Cochrane's risk of bias tool was used to assess the methodological quality and Review Manager 5.3 software was used to analyze data.ResultsA total of 12 RCTs involving 835 patients were finally included. According to interventions, RCTs were divided into two types. The intervention in 10 RCTs was SP combined with conventional pharmacotherapy (CPT) versus CPT and that in 2 RCTs was SP alone versus CPT. The results of the meta-analysis showed that, compared with CPT alone, SP combined with oral CPT has better improvement in BASDAI (WMD?=?-1.84, 95% CI [-3.31, -0.37], P=0.01), morning stiffness time (WMD?=?-13.46, 95% CI [-16.12, -10.79], P < 0.00001), the Schober test (WMD?=?1.26, 95% CI [0.72, 1.80], P < 0.00001), the occipital wall test (WMD?=?-0.55, 95% CI [-0.96, -0.14], P=0.009), the finger-to-ground distance (WMD?=?-3.28, 95% CI [-5.64, -0.93], P=0.006), 15?m walking time (WMD?=?-8.81, 95% CI [-13.42, -4.20], P=0.0002), the C-reactive protein (CRP) (WMD?=?-1.84, 95% CI [-3.24, -0.45], P=0.01), and the total effective rate (RR?=?1.10, 95% CI [1.01, 1.20], P=0.03). Besides, it also showed that oral SP alone may be more effective in improving morning stiffness time (WMD?=?-31.89, 95% CI [-34.91, -28.87], P < 0.00001) compared with CPT alone. However, this study cannot provide evidence that loading the injectable SP based on CPT can significantly increase the efficacy due to the insufficient number of studies included. In terms of adverse events, there was no statistically significant difference between the experimental group and the control group.ConclusionsThis study shows that oral SP may be effective and safe in the treatment of AS. Due to the low methodological quality of the included RCTs and the limitations of the meta-analysis, it is still necessary to carry out more multicenter, large-sample, and high-quality RCTs to further verify the conclusions. The review protocol was registered on PROSPERO (CRD42018099170), and the review was constructed following the PRISMA guidelines (Annex 1).

Dataset Information

Short-Term Efficacy and Safety of Secukinumab for Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of RCTs.

Publications

Short-Term Efficacy and Safety of Secukinumab for Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of RCTs.

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