Background:The anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis.Objective:To evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed.Methods:This 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24.Results:The intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p<0.001), and 28-joint Disease Activity Score (DAS28) <2.6 rate (33.6 vs 12.1%) at week 24. Mean high-sensitivity C-reactive protein was within the normal range from week 12 with tocilizumab, whereas levels remained elevated with methotrexate. The incidence of serious adverse events with tocilizumab was 3.8% versus 2.8% with methotrexate (p = 0.50), and of serious infections, 1.4% versus 0.7%, respectively. There was a higher incidence of reversible grade 3 neutropenia (3.1% vs 0.4%) and increased total cholesterol ⩾240 mg/dl (13.2% vs 0.4%), and a lower incidence of alanine aminotransferase elevations >3×–<5× upper limit of normal (1.0% vs 2.5%), respectively.Conclusion:Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotrexate or biological agents has not previously failed.Trial registration number:NCT00109408

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Objective The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. Methods In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Results Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (− 2.7 and − 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. Conclusion CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. ClinicalTrials.gov identifier NCT02149121. Electronic supplementary material The online version of this article (10.1007/s40259-018-00331-4) contains supplementary material, which is available to authorized users.

La osteoporosis es un problema de salud pública a nivel mundial, particularmente en mujeres posmenopáusicas, jugando la deficiencia de vitamina D un importante rol en su génesis. Objetivo: Determinar los niveles de Vitamina D en mujeres posmenopáusicas con osteoporosis primaria. Material y métodos: Estudio descriptivo tipo serie de casos. Se incluyeron 40 mujeres posmenopáusicas con diagnóstico de osteoporosis primaria; se excluyeron las que habían recibido suplemento de calcio o vitamina D, terapia para osteoporosis o tenían alguna causa de osteoporosis secundaria. A todas las mujeres incluidas se les determinó el nivel sérico de 25 OH vitamina D. Resultados: La edad promedio fue 65,9 ± 10,22 años, y el promedio del Score T L1-L4 fue -2,82 ± 0,71, Score T en Cadera Total -1,59 ±1,05 y el Score T en radio 33% -3,10 ± 0,97 en la densitometría ósea. El nivel de vitamina D sérico fue 13,98 ± 5,95 ng/ml; 87,5% (35 pacientes) tuvieron niveles de vitamina D deficientes, 7,5% (3 pacientes) tenían niveles insuficientes y sólo 2 pacientes tuvieron niveles normales de vitamina D. Conclusión: La mayoría de mujeres posmenopáusicas con osteoporosis primaria tuvieron niveles de vitamina D en rangos de deficiencia e insuficiencia. Podría ser necesario dar suplementos de calcio y vitamina D a todas las pacientes posmenopáusicas con osteoporosis.(Rev Med Hered 2011; 22;10-14).