ObjectivesMAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).MethodsThis phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.ResultsPatients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).ConclusionsSecukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial registration numberNCT02721966.
Omega-3 fatty acids did not show an effect on extending the remission in Crohn's disease. For the diet patients the question remains whether the noncompliant patients dropped out early because they sensed a relapse approaching or whether their condition deteriorated because they failed to comply with the diet.
In dogs with idiopathic acute haemorrhagic diarrhoea syndrome (AHDS), a serious loss of intestinal mucosal barrier integrity occurs. However, the incidence of bacterial translocation in dogs with idiopathic AHDS is not known. Thus, the objectives of this prospective study were to identify the incidence of bacteraemia, to evaluate the frequency of septic events and the influence of bacteraemia on various clinical and laboratory parameters, duration of hospitalisation and survival of dogs with idiopathic AHDS. The study included 87 dogs with idiopathic AHDS. Twenty-one healthy dogs served as control group. To evaluate clinical significance of bacterial translocation, blood culture results were compared between patients and controls. Clinical and laboratory parameters were compared between patients with positive and negative blood cultures. There was no significant difference in either incidence of bacteraemia between patients with idiopathic AHDS (11 per cent) and controls (14 per cent) or in severity of clinical signs, laboratory parameters, duration of hospitalisation or mortality between blood culture-positive and culture-negative dogs with idiopathic AHDS. The results of this study suggest that the incidence of bacteraemia in dogs with idiopathic AHDS is low and not different from that of healthy control dogs. Bacteraemia does not influence the clinical course or survival and thus antibiotic treatment is not indicated to prevent sepsis.
The aim of this study was to investigate the prevalence of bacterial species isolated from bronchoalveolar lavage fluid (BALF) samples taken from dogs with respiratory signs and to determine their antibiotic susceptibility. Clinical cases were included in the study if they showed signs of respiratory disease and data relating to bacterial culture and susceptibility of BALF samples were available. The medical records of 493 privately owned dogs that were presented between January 1989 and December 2011 were evaluated retrospectively. In 35 per cent of samples, no bacteria were cultured. Bacteria isolated from culture-positive samples included Streptococcus species (31 per cent of positive cultures), Enterobacteriaceae (30 per cent, including Escherichia coli (15 per cent)), Staphylococcus species (19 per cent), Pasteurella species (16 per cent) and Pseudomonas species (14 per cent). Bordetella bronchiseptica as a primary respiratory pathogen was isolated in 8 per cent of cases. Enrofloxacin showed the best susceptibility pattern; 86 per cent of all isolates and 87 per cent of Gram-negative bacteria were susceptible to this antibiotic. Amoxicillin/clavulanic acid yielded the best susceptibility pattern in Gram-positive bacteria (92 per cent). Therefore, these antibiotics can be recommended for empirical or first-line treatment in dogs with bacterial lower respiratory tract infections.
BackgroundSecukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) and ankylosing spondylitis 1. Evidence on the efficacy of biologics in the treatment of PsA patients (pts) with axial manifestations affecting 30–70% of PsA pts is limited2, particularly as validated classification criteria for this subtype of PsA are not yet available; an effort to develop criteria is being undertaken by ASAS/GRAPPA. MAXIMISE is an ongoing study evaluating the efficacy and safety of secukinumab 300 or 150mg in managing axial manifestations in PsA ptsObjectivesTo report the primary analysis results at Week (Wk) 12 from MAXIMISE (NCT02721966) trialMethodsThis phase 3b, double blind, placebo (PBO)-controlled, multicentre 52-wk trial included 498 pts (aged ≥18 years) with PsA (CASPAR criteria), clinician-diagnosed axial involvements, spinal pain VAS >40/100 and BASDAI >4 despite trial of at least two NSAIDs. Pts were randomised to subcutaneous (SC) SEC (300/150 mg) or PBO weekly for 4 wks and every 4 wks thereafter. At Wk 12, PBO pts were re-randomised to SC SEC 300/150 mg. The primary endpoint was proportion of pts achieving ASAS20 response with SEC 300 mg at Wk 12. The key secondary endpoint was ASAS20 response with SEC 150 mg at Wk 12 after superiority of 300 mg was established. Analyses used multiple imputationResultsDemographic and baseline (BL) disease characteristics were comparable across groups (Table). Primary and key secondary endpoints were met; ASAS20 response rates at Wk 12 were 63.1% (SEC 300 mg; P<0.0001) and 66.3% (150 mg; P<0.0001) vs 31.3% (PBO; Figure). ASAS20 responses in pts using concomitant MTX were 65.1% [300 mg], 67.3% [150 mg] vs 33.9% [PBO] and corresponding values in No MTX group were 60.5%, 64.4% vs 27.1%. The safety profile was similar across groups through Wk 12ConclusionMAXIMISE is the first randomised controlled trial evaluating the efficacy of a biologic in the management of the axial manifestations of PsA. SEC 300 and 150 mg provided rapid and significant improvement in ASAS20 responses through Wk 12 in PsA pts with axial manifestations and inadequate responses to NSAIDsReferences[1] Lubrano E and Perrotta FM. Ther Clin Risk Manag. 2016;12:1587-92[2] Feld J, et al. Rheum Rev.2018;14:363 Demographics/BL Characteristics Mean (SD) unless specified SEC300 mg SC(N = 167) SEC150 mg SC(N = 165) PBO(N = 166) Age (yrs) 46.2 (12.3)46.9 (11.5) 46.6 (11.5) Male, n (%) 77 (46.1) 81 (49.1) 88 (53.0) Evidence of current psoriasis, n (%) 152 (91.0)147 (89.1)153 (92.2) Time since first axial symptoms (yrs) 6.8 (7.7)7.4 (7.6)7.7 (9.5) Total back pain score, VAS 72.5 (13.8)73.6 (15.3) 74.0 (13.7) Inflammatory back pain parameters, n (%) Onset of back pain is insidious 150 (89.8) 147 (89.1) 152 (91.6) Back pain improving with exercise 148 (88.6) 139 (84.2) 146 (88.0) Back pain worsening with rest 152 (91.0) 151 (91.5) 157 (94.6) Night pain with improvement upon getting up 147 (88.0) 147 (89.1) 143 (86.1) Awakening due to back pain in 2nd ...
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