Subcutaneous Infliximab (CT-P13) as Maintenance Therapy for Inflammatory Bowel Disease: 2 Randomized Phase 3 Trials.

BACKGROUND & AIMS: CT-P13 subcutaneous (SC), an SC formulation of the intravenous (IV) infliximab biosimilar CT-P13 IV, creates a unique exposure profile. We aimed to demonstrate superiority of CT-P13 SC vs placebo as maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC). METHODS: Two randomized, placebo-controlled, double-blind studies were conducted in patients with moderately to severely active CD or UC and inadequate response or intolerance to corticosteroids and immunomodulators. All patients received open-label CT-P13 IV 5 mg/kg at weeks 0, 2, and 6. At week 10, clinical responders were randomized (2:1) to CT-P13 SC 120 mg or placebo every 2 weeks until week 54 (maintenance phase) using prefilled syringes. Co-primary end points were clinical remission and endoscopic response (CD) and clinical remission (UC) at week 54 (all-randomized population). RESULTS: Overall, 396 patients with CD and 548 patients with UC received induction treatment. At week 54 in the CD study, statistically significant higher proportions of CT-P13 SC-treated patients vs placebo-treated patients achieved clinical remission (62.3% vs 32.1%; P < .0001) and endoscopic response (51.1% vs 17.9%; P < .0001). In the UC study, clinical remission rates at week 54 were statistically significantly higher with CT-P13 SC vs placebo (43.2% vs 20.8%; P < .0001). Achievement of key secondary end points was significantly higher with CT-P13 SC vs placebo across both studies. CT-P13 SC was well tolerated, with no new safety signals identified. CONCLUSIONS: CT-P13 SC was more effective than placebo as maintenance therapy and was well tolerated in patients with moderately to severely active CD or UC who responded to CT-P13 IV induction. CLINICALTRIALS: gov, Numbers: NCT03945019 (CD) and NCT04205643 (UC).

Review of patients with hepatosteatosis and chronic hepatitis C.

We analysed a HCV RNA positive population with varied steatosis index admitted at Infectious Diseases and Hepatology Department, Medical University of Wroclaw in terms of existing abnormalities in biochemistry parameters, anthropometric differences as well as the antiviral therapy outcomes.

[Diagnostic and therapeutic aspects of hepatitis C virus induced thrombocytopenia (HCV-TP)]. / Aspekty diagnostyczne i terapeutyczne maloplytkowosci indukowanej zakazeniem wirusem C zapalenia watroby (HCV-TP).

Hepatitis C virus induced thrombocytopenia (HCV-TP) is a problematic disorder for diagnosis and treatment both for the infectious diseases specialists and hematologists. In the relation we decided to the present most up-to date views upon the HCV-TP patomechanism and systematized the diagnostic methods and therapeutic possibilities.

[Critical evaluation of reporting on postexposure skin damage incidents and its consequences for Polish health workers]. / Krytyczna ocena rejestracji ekspozycji zawodowych zwiazanych z naruszeniem ciaglosci tkanek oraz wynikajacych z tego konsekwencji--wsród pracowników polskiej sluzby zdrowia.

BACKGROUND: The principles of uniform reports on infections with HBV, HCV, HIV due to occupational exposure have not yet been established in Poland. Usually, reporting on such incidents is governed by internal rules of individual health care institutions. The aim of the study was to assess the possibility of obtaining data on postexposure incidents among health care workers in different voivodeships (regions) and to identify a group of persons who most frequently reported such cases in a given calendar year. MATERIAL AND METHODS: Nineteen medical centers from all 16 voivodeships were invited to participate in the study. The main condition to be enrolled in the study was to provide full postexposure prophylaxis log. RESULTS AND CONCLUSIONS: In all, 8 centers from 8 voivodeships were enrolled in the final study. Only in 4 voivodehips, completely centralized postexposure prophylaxis logs were in operation. Women with secondary education (nurses) formed the major group of exposed persons. Exposure incidents occurred most frequently in wards or operation rooms while performing medical procedures or immediately after. Blood collection predominated among various kinds of exposure. The majority (75.7%) of health workers underwent full vaccination program against HBV. The analysis revealed large differences in exposure reporting between individual voivodeships. Sometimes they made it even difficult to complete full demographic data concerning exposed persons. Therefore, a universal tool of nationwide system should be elaborated. Such a system (an example is presented by the authors), regularly verified, might provide grounds for a wider analysis of postexposure prophylaxis efficacy, details concerning exposure incidents and their consequences in the future. This may greatly contribute to the reduction of exposure rates among health care workers.

[Underestimation of exposure incidence rates in Polish health workers: a prospective study]. / Ocena niedoszacowania czestosci ekspozycji na material biologiczny wsród pracowników polskiej sluzby zdrowia--analiza prospektywna.

BACKGROUND: Analyses of exposure rates among health care workers comprise both risk and epidemiology of blood borne pathogenic factors. In Poland, a possible extent of underestimation of such incidents has not yet been widely studied in the population of this group of employees. The aim of the study was to observe a group of population chosen as an example to assess the actual exposure incidence rates, especially those not subjected to registration. MATERIALS AND METHODS: A prospective six-month survey covered 319 Lower Silesia health care workers: physicians, nurses and auxiliary staff. Statistical methods were used to analyze the obtained data, especially those concerning the job performance, the number of medical procedures performed and frequency of exposures, both registered in each case and not registered in the post-exposure prophylaxis log. RESULTS AND CONCLUSIONS: Finally, 269 persons were under observation. Actual exposure incidence rate was several fold higher than that officially registered and differed depending on the department and subgroup of health care workers. In summary, the ratio of all the registered cases to those not registered was 1: 6. An overall proportion of not registered cases of exposure was as high as 86%. Most frequent job activities of exposed health care workers comprised preparatory procedures like parenteral drug administration or injections. Post-procedure activities were less frequently the cause of exposure. Non-registration of such exposures were motivated by a self-assessment of a low infection risk or a conviction that self-protection on the incidence site was optimal. Lack of current knowledge was rather rarely admitted as a reason for underreporting.

[Fatty liver disease--mechanism, clinical significance and factors with a special regard to primary hepatotropic viruses]. / Stluszczenie watroby--patomechanizm, znaczenie kliniczne i czynniki sprawcze, ze szczególnym uwzglednieniem wirusów pierwotnie hepatotropowych.

Fatty liver disease is one of most frequently diagnosed hepatopathies while detailed examination of potential causes of liver enzymes abnormalities is done. Despite its isolated nosology fatty liver disease often co-exists with other liver pathologies or - more often - it is their natural consequence. Liver steatosis is also more often found in primary hepatotropic viral infections. However, it's more prevalent among HCV (hepatitis C virus) infected persons than in those HBV (hepatitis B virus) infected. It is described in 30-70% routinely pursued liver biopsies in HCV infected individuals. Hitherto, there were many analyses concerning clinical and prognostic implications pursued of HCV influence upon inflammatory and fibrotic process of the liver. This article is an up-to-date review of current clinical and therapeutic implications of hepatosteatosis supported by referent study results.

[Autoimmune liver diseases and overlap syndromes--overview of past and present reports]. / Autoimmunologiczne choroby watroby a zespoly nakladania--poglad na dawne i aktualne doniesienia.

Autoimmune liver diseases are unique among other liver diseases mainly for its unknown pathogenesis, treatment and prognosis. Within their natural course strong correlation between clinical view and serologic markers (autoimmune hepatitis, primary biliary cirrhosis) or X-ray image abnormalities (primary sclerocholangitis) are observed. Significant diagnostic progress, recently seen, revealed major discrepancies in diagnosing and management of classic types of the diseases, suggesting co-association of their symptoms. This review presents former and most up-to-date reports of such cases in terms of overlap syndromes.