ObjectivesTo compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.MethodsPhase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity.ResultsAt week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively.ConclusionsCT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX.ClinicalTrials.gov IdentifierNCT01217086

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We assessed the prevalence and incidence of Systemic Lupus Erythematosus (SLE) in 2010 in adults from four cities in Russia, Kazakhstan and Ukraine. Individuals with SLE were identified retrospectively from the medical records of specialized centers. Prevalent SLE patients were nondeceased city residents, diagnosed prior to December 31, 2010; incident patients were residents newly diagnosed between January 1 and December 31, 2010. Population size was obtained from official census data. The observed prevalence rates (per 100,000, 95% CI) were 9.0 (7.1-11.2) in Kursk and Yaroslavl, Russian Federation; Kazakhstan; in Vinnitsa, Ukraine. The cumulative incidence rates (per 100,000, 95% CI) were 1.4 (0.7-2.4); 1.6 (0.4-4.1) and 0.3 (0.0-1.8), correspondingly. All rates were higher among females compared to males, and incidence peaked in the population aged 25-44. These rates appear slightly lower than those reported from Western Europe and the USA. This could be because of study design (case-ascertainment), local health care practices or true differences in disease risk. Case age and sex distribution was similar to the known epidemiology of SLE. The rates were highest in Kazakhstan, likely because of a predominantly ethnic Asian population. Lupus (2014) 23, 213-219.

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The synthesis and X-ray structure of a C 2 symmetric secochlorin 2, obtained by a photosensitized oxidative ring opening of a 2,3-dimethoxy porphyrin, is described. † Electronic supplementary information (ESI) available: experimental details. See http://www.rsc.org/suppdata/cc/b1/b102139g/ Scheme 1 Fig. 1 Absorption spectra of porphyrin 4 and secochlorin 2. CH 2 Cl 2 solutions, room temperature.