ABSTRACT
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, Nâ=â305; placebo, Nâ=â153) 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%; Pâ<â0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (Pâ<â0.01). 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.
Subject(s)
Spondylitis, Ankylosing , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , China , Double-Blind Method , Humans , Spondylitis, Ankylosing/drug therapy , Treatment OutcomeABSTRACT
OBJECTIVE: To discuss the diagnostic value of cardiac enzyme and troponin in acute organophosphorus pesticide poisoning (AOPP). METHODS: A retrospective study was performed in the document published in domestic journals and PubMed from 1979 to 2010. The data of the cardiac enzyme and troponin were collected. Statistical analysis was conducted with one-way ANOVA and rank sum test. 2129 cases with AOPP were enrolled. RESULTS: The levels of creatine kinase (CK), creatine kinase-MB (CK-MB) and cardiac troponin I (cTnI) in milder, moderate and severe poisoning groups were significantly elevated compared by the healthy control group (P < 0.05). The differences were also dramatic among three patients groups (P < 0.05). The ratios of CK-MB to CK in both moderate and severe groups were significantly lower than in healthy controls (P < 0.05). The levels of CK, CK-MB and cTnI were higher especially in patients with intermediate myasthenic syndrome (IMS) than patients without IMS. Meanwhile, the levels of CK and CK-MB were elevated in patients with respiratory failure compared by non-failure ones, but decreased in the ratios of CK-MB to CK (P < 0.05). CONCLUSIONS: The elevation of CK and CK-MB in serum could not be judged as the criteria of myocardial damage in AOPP, the ratio of CK-MB to CK were more valuable; the value of cTnI in myocardial damage was still in suspect. CK, CK-MB and cTnI could be used as auxiliary criteria of AOPP classification.
Subject(s)
Cardiomyopathies/diagnosis , Myocardium/metabolism , Organophosphate Poisoning/metabolism , Adolescent , Adult , Aged , Aged, 80 and over , Cardiomyopathies/etiology , Child , Child, Preschool , Creatine Kinase/blood , Creatine Kinase, MB Form/blood , Female , Humans , Infant , Male , Middle Aged , Myocardium/enzymology , Myocardium/pathology , Troponin I/blood , Troponin T/blood , Young AdultABSTRACT
OBJECTIVE: To discuss the effectiveness of severe and acute organophosphate poisoning (AOPP) treated with plasma exchange in China. METHODS: Researches about effectiveness of severe AOPP treated with plasma exchange were analyzed by Review Manager 4.2 and fixed effect model of meta-analysis method were used. RESULTS: Six trials including 433 patients were identified. Treatment group including 211 patients adopted traditional physician therapy plus plasma exchange, and control group including 222 patients received physician therapy only. The case-fatality rate of the treatment group was lower than the control one [RR=0.30, 95%CI (0.19-0.49), P<0.01]. CONCLUSION: Plasma exchange can improve the cure rate of severe AOPP.