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Objectives We report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Methods Patients [both GLM- and placebo (PBO)-treated in the double-blind phase] received GLM 50 mg every 4 weeks during the OLE (36-week treatment; additional 8-week safety follow-up; GLM/GLM and PBO/GLM groups). All patients who entered and received ≥1 dose of study treatment in the OLE were included in the efficacy and safety analyses. The primary efficacy evaluations were the proportions of patients achieving 20% and 40% improvement in the ASAS criteria (ASAS20 and ASAS40, respectively). Responders’ analyses were calculated using a non-responder imputation approach. Results Of 198 patients randomised, 189/198 (95.5%) entered the OLE; 174/198 patients (87.9%) completed all visits. Although the proportion of responders increased from week 16 to week 52 in the OLE in both GLM/GLM and PBO/GLM groups, the GLM/GLM group had a higher proportion of responders than the PBO/GLM group throughout the OLE from week 16 to week 52 (ASAS20: 71.1% to 83.9% vs 40.0% to 75.0%, respectively; ASAS40: 56.7% to 76.3% vs 23.0% to 59.4%, respectively; ASAS partial remission: 33.0% to 53.8% and 18.0% to 45.8%). In the OLE, the overall incidence of AEs was lower in the GLM/GLM vs PBO/GLM groups (41.9% and 54.2%). Conclusions Sustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment. GLM was well tolerated and provided substantial long-term benefits to patients with nr-axSpA. Trial registration NCT01453725; United States National Library of Medicine clinical trials database; www.clinicaltrials.gov.

The drama of empire, by Walter Marsham Adams (1838-1899); published in 1891 by Kegan Paul, Trench, Trübner & Co., London. With a map of Africa, by George Philip & Son, London and Liverpool, inserted between pages 192 and 193.

We have discovered mesoionic pyrido[1,2-a]pyrimidinones as a novel class of insecticides and identified compounds such as dicloromezotiaz for development. During optimization of this area, we also discovered that mesoionic pyrido[1,2-a]pyrimidinones containing 3-biaryl groups at the 3-position of the core ring possess potent biological activity against Lepidoptera species. In this chapter, we will present the discovery, preparation, and optimization of this class of compounds. Biological activity of representative analogs will also be presented.

Background This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. Methods Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). Results Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with baseline partial Mayo score 7-9: 46.0% vs 30.5%, respectively). During 5 years of follow-up, 271 patients (12.1% of enrolled patients) had colectomy. Enrollment in the IFX group was associated with a higher risk of colectomy (hazard ratio = 3.12; 95% confidence interval, 2.25-4.34; P Conclusions Colectomy was reported at a higher rate in the IFX group than in the ConvRx group, although patients in the IFX group had more severe disease at baseline and most of the colectomies occurred after patients had been off of IFX for ≥90 days.

Background and Aims The Observational Postmarketing Ulcerative colitis Study [OPUS] was conducted to obtain the first long-term [5 years] safety data assessing treatment with originator infliximab versus conventional therapies in patients with ulcerative colitis [UC] in real-world clinical practice. Methods The OPUS registry was a prospective, non-randomised, observational study that measured adverse events in nine prespecified categories of interest in UC patients whose treatment with either originator infliximab or conventional therapy [defined as initiation or dose-increase of corticosteroids and/or immunosuppressants] was determined by their treating physician. Results Data for 2239 patients were available: N = 1180 enrolled to conventional therapy [including N = 296 who switched to originator infliximab during follow-up] and N = 1059 enrolled to originator infliximab. Patients in the originator infliximab group, compared with the conventional therapy group, had more severe disease at baseline, based on partial Mayo score [PMS]: 46.0% of patients in the originator infliximab group had severe disease (PMS of 7–9 [out of 9]), compared with 30.5% in the conventional therapy group. In adjusted time-to-event analyses, enrolment into the originator infliximab group was associated with a higher risk of serious infection (hazard ratio = 1.98 [95% confidence interval: 1.34, 2.91; p Conclusions UC patients treated with infliximab had higher risk for serious infection, compared with conventional therapies. No new safety concerns were observed with originator infliximab in the OPUS registry. [ClinicalTrials.gov: NCT00705484.]

Class III malocclusion associated with posterior crossbite, anterior open bite pattern with asymmetric occlusion in adults can be a challenging orthodontic problem, especially for the nonsurgical treatment. Skeletal Class III anteroposterior discrepancies in adult patients are generally managed either by surgical-orthodontic treatment or by orthodontic camouflage through dentoalveolar compensation. Although correction with surgery may be the most effective and stable way, many patients refuse surgical treatment plan because of the costs and traumas it may bring. This case report describes the successful use of TADs with expansion auxiliary wire to treat a 24-year-old man with skeletal class III malocclusion, posterior crossbite, anterior open-bite and asymmetric occlusion, mild upper and lower dental spacing and a chief manifestation of anterior crossbite. The patient refused surgery. A treatment plan was formulated consisting of using auxiliary expansion wire to expand the maxillary arch, 8 mm mini-screws between the roots of the mandibular canines and first premolars, preadjusted edgewise brackets to align the teeth, Class III and asymmetric elastics to correct the canines, premolars, and molars relationship and midline deviation, reverse curve of the nickel-titanium wire combined with anterior vertical elastics to intrude molars and correct the anterior open-bite. In this case, without going through surgery, the posterior cross-bite was corrected, and ideal overjet and overbite relationships, midline coincidence and functional occlusion were all achieved. Satisfactory occlusal, functional, esthetic and stable results were obtained.