October 2016

Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial

Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.PROs assessed were: Patient Global Assessme...

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August 2016

Risk for Lower Intestinal Perforations in Patients with Rheumatoid Arthritis Treated with Tocilizumab in Comparison to Treatment with Other Biologic or Conventional Synthetic DMARDs

Ann Rheum Dis 2016;0:1–7 DOI 10.1136/annrheumdis-2016-209773.

This real-life study confirms findings from the tocilizumab (TCZ) clinical development program that IL-6 inhibition with TCZ may be associated with increased risk of lower intestinal perforation (LIP). Data were analysed from the RABBIT register of patients. The primary outcome was the incidence of LIPs in patients exposed to TCZ, csDMARDs, TNFis, abatacept, or rituximab. Thirty-seven LIPs were observed in 53,972 patient years. The proportion of patients who developed a LIP was higher in patient...

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May 2016

Extended-release once-daily formulation of tofacitinib: evaluation of pharmacokinetics compared with immediate-release tofacitinib and impact of food

J Clin Pharmacol. 2016 Mar 11. doi: 10.1002/jcph.734. [Epub ahead of print]

PK profile of TOF is rapid absorption and elimination with time to max concentration 0.5-1 hour and terminal half-life at 3 hours. It is currently approved for immediate release (IR) 5 mg BID, 10 mg total; however, decreasing the dosage to QD dosing may help increase compliance. This study performed in 24 healthy males compared the PK of XR and IR TOF under both single and multiple dose conditions and evaluated the effect of a high-fat meal on the PK of XR TOF. There were no clinically important...

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