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Alten R.E.,University Medicine | Zerbini C.,Hospital Heliopolis | Jeka S.,NZOZ Nasz Lekarz | Irazoque F.,Servicio de Reumatologia | And 5 more authors.
Annals of the Rheumatic Diseases | Year: 2010

Objective: To determine the efficacy and safety of pamapimod in adult patients with active rheumatoid arthritis (RA) who had an inadequate clinical response to methotrexate (MTX). Methods: Patients receiving stable doses of MTX were randomised to one of six dose groups and received 12 weeks of double-blind pamapimod (up to 300 mg once daily) or matching placebo. The primary efficacy measure was the proportion of patients with ≥20% improvement in RA based on the American College of Rheumatology criteria (ACR20) at 12 weeks. Secondary measures were ACR50, Disease Activity Score (DAS)/ European League Against Rheumatism (EULAR) responses and the individual ACR core set of parameters. Safety measures included adverse events (AEs), laboratory testing and immunology assessments. Results: On a background of MTX, the percentage of patients with an ACR20 response at week 12 in the pamapimod groups (31% to 43%) was not significantly different from placebo (34%). Secondary efficacy end points showed a similar pattern. AEs were typically mild and included infections, gastrointestinal disturbances, dizziness and rashes; AEs resulting in discontinuation of study drug were primarily attributed to infections. Conclusion: In patients with active RA receiving stable doses of MTX, pamapimod showed non-significant improvement in efficacy outcomes compared to placebo.

Coombs J.H.,Pfizer | Bloom B.J.,Pfizer | Breedveld F.C.,Leiden University | Fletcher M.P.,Pfizer | And 6 more authors.
Annals of the Rheumatic Diseases | Year: 2010

Objectives: To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor a inhibitor. Methods: Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks' follow-up. The patient's assessment of arthritis pain (pain), patient's assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded. Results: At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (≥0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components. Conclusions: CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

Bastos De Souza T.R.,Hospital A C Camargo | Pinto C.A.L.,Hospital A C Camargo | Da Cunha Mercante A.M.,Hospital Heliopolis | Nishimoto I.N.,Hospital A C Camargo | And 2 more authors.
Head and Neck | Year: 2014

Background The purpose of this study was to review the oncologic and functional outcomes of patients with clinical stage III or IV squamous cell carcinoma (SCC) of the oropharynx submitted to tumor resection and neck dissection with or without postoperative radiotherapy (PORT). Methods We conducted a retrospective review of medical charts of 256 consecutive patients. Results Fatal postoperative complications were registered in 5 patients (1.9%). During follow-up, there were 74 local recurrences (29%), 27 neck recurrences (10.5%), and 19 distant metastases (7.4%). The 5-year overall survival (OS) was 43.0%. The Cox multivariate model identified pT3 and pT4, pN2 and pN3, and an intense lymphocytic infiltrate as independent prognostic markers for OS. The 5-year disease-free survival (DFS) rate was 54.5%. Conclusion Surgical treatment for oropharyngeal carcinoma can be performed with a low-risk of postoperative mortality but with a risk of long-term use of tracheostomy and feeding tubes. © 2013 Wiley Periodicals, Inc. Head Neck 36: 1146-1154, 2014 Copyright © 2013 Wiley Periodicals, Inc.

Combe B.,Montpellier University | Dasgupta B.,University of the Sea | Louw I.,Panorama Medical Center | Pal S.,Advance Rheumatology Clinic | And 7 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives: To evaluate the efficacy and safety of subcutaneous golimumab as add-on therapy in patients with active rheumatoid arthritis (RA) despite diseasemodifying antirheumatic drug (DMARD) treatment. To evaluate an intravenous plus subcutaneous (IV+SC) golimumab strategy in patients who had not attained remission. Methods: GO-MORE was an open-label, multinational, prospective study in patients with active RA in typical clinical practice settings. In part 1, patients received addon monthly 50-mg subcutaneous golimumab for 6 months. The percentage of patients with good/ moderate European League Against Rheumatism (EULAR) 28-joint disease activity score (DAS28)- erythrocyte sedimentation rate (ESR) response was compared in patient subgroups with various concurrent or previous DMARD treatments. In part 2, patients with EULAR responses but not remission were randomly assigned to receive IV+SC or subcutaneous golimumab to month 12; DAS28-ESR remission was measured. Results: 3366 patients were enrolled. At baseline of part 1, 3280 efficacy-evaluable patients had mean disease duration of 7.6 years and mean DAS28-ESR of 5.97 (SD=1.095). At month 6, 82.1% achieved good/ moderate EULAR responses and 23.9% attained remission. When EULAR responses were analysed by the number of previously failed DMARD or the concomitant methotrexate dose, DMARD type, or corticosteroid use, no statistically significant differences were observed. Part 2 patients (N=490) who received IV+SC or subcutaneous golimumab achieved similar remission rates (∼25%). Adverse events were consistent with previous reports of golimumab and other tumour necrosis antagonists in this population. Conclusions: Add-on monthly subcutaneous golimumab resulted in good/moderate EULAR response in most patients; 25% achieved remission after 6 more months of golimumab, but an IV+SC regimen provided no additional efficacy over the subcutaneous regimen.

Boing A.F.,Federal University of Santa Catarina | Antunes J.L.F.,Federal University of Santa Catarina | Antunes J.L.F.,University of Sao Paulo | de Carvalho M.B.,Hospital Heliopolis | And 6 more authors.
Journal of Epidemiology and Community Health | Year: 2011

Background A higher burden of head and neck cancer has been reported to affect deprived populations. This study assessed the association between socioeconomic status and head and neck cancer, aiming to explore how this association is related to differences of tobacco and alcohol consumption across socioeconomic strata. Methods We conducted a case-control study in São Paulo, Brazil (1998e2006), including 1017 incident cases of oral, pharyngeal and laryngeal cancer, and 951 sexand age-matched controls. Education and occupation were distal determinants in the hierarchical approach; cumulative exposure to tobacco and alcohol were proximal risk factors. Outcomes of the hierarchical model were compared with fully adjusted ORs. Results Individuals with lower education (OR 2.27; 95% CI 1.61 to 3.19) and those performing manual labour (OR 1.55; 95% CI 1.26 to 1.92) had a higher risk of disease. However, 54% of the association with lower education and 45% of the association with manual labour were explained by proximal lifestyle exposures, and socioeconomic status remained significantly associated with disease when adjusted for smoking and alcohol consumption.

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