Dysmobility syndrome: a case-series study describing a musculoskeletal syndrome in postmenopausal Mexican women.

"Dysmobility Syndrome" (DS) is a term that correlates sarcopenia and osteoporosis together with mobility disturbances, obesity, fractures, and falls. The prevalence of DS is of 74% in this study. Further research with bigger sample sizes is needed to describe if prevalence and DS characteristics are similar in other studies. PURPOSE: "Dysmobility Syndrome" (DS) correlates sarcopenia and osteoporosis together with mobility disturbances, obesity, fractures, and falls, all of which are related to adverse outcomes in the health of the elderly; however, there are no studies of DS in Mexican patients. In this study, we aimed to describe the characteristics of DS in Mexican postmenopausal women from a private practice. METHODS: A case-series study was conducted; women of 60 years and older were invited to participate from August to December of 2019, a total of 50 patients were included. Medical history, physical tests, bone densitometry, and body composition analysis were performed; patients who met 3 or more of the following criteria were diagnosed with DS: osteoporosis: T-score ≤ -2.5, falls in a previous year, lean appendicular mass: ≤ 5.45 kg/m2, walking speed: < 1.0 m/s, grip strength: < 20 kg, and body fat percentage: > 40%. RESULTS: Out of the total 50 patients, 37 were diagnosed with DS, with a prevalence of 74% in our study. Sixteen patients had a history of a non-vertebral fragility fracture, of which 14 had a diagnosis of DS (87%). CONCLUSIONS: DS has a high frequency in our study group, and was found to be closely related to the presence of non-vertebral fragility fractures. More research is needed to describe the prevalence and characteristics of DS with a stronger statistical significance within our population, and among others across the country, to get an extensive understanding of its presentation in Mexican women. KEY POINTS: • The frequency of DS in this study is higher than the one that is described in global literature. • DS diagnosis is closely related to the antecedent of non-vertebral fragility fracture.

Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.

OBJECTIVE: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. METHODS: Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. RESULTS: At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. CONCLUSION: Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. TRAIL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.

A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis.

OBJECTIVE: To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents. METHODS: In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC0-last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24. RESULTS: 103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%-125% (AUC0-last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles. CONCLUSIONS: CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety. TRIAL REGISTRATION NUMBER: NCT01534884.