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        Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria

        Sadik Saman,Martin Goetz,Judith Wendler,Nisar P. Malek,Jan Wehkamp,Thomas Klag 대한장연구학회 2019 Intestinal Research Vol.17 No.3

        Background/Aims: Ustekinumab is effective in active Crohn’s disease. In a retrospective study, we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes. Methods: Forty-one patients with mild to severe active Crohn’s disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn’s Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed. Results: The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies. Conclusions: Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.

      • KCI등재

        Biosorption of Pb(II) onto immobilized and native Mangifera indica waste biomass

        Raziya Nadeem,Qaisar Manzoor,Munawar Iqbal,Jan Nisar 한국공업화학회 2016 Journal of Industrial and Engineering Chemistry Vol.35 No.-

        The removal of Pb(II) from simulated solution and wastewater using native and immobilized Mangiferaindica biomass (MIB) were studied as a function of pH, initial concentration, biosorbent dose and contacttime. The biosorption data was analyzed using pseudo-first and pseudo-second order kinetic models andLangmuir, Freundlich and Temkin isotherms. The immobilized biomass did not show promisingefficiency for the adsorption of Pb(II) as compared to native biomass. The SEM and EDX analysisconfirmed the Pb(II) adsorption onto MIB. FTIR and desorption studies were also performed. TheLangmuir model and pseudo-second order kinetic fitted well to the adsorption experimental data.

      • KCI등재

        Quality of life in inflammatory bowel diseases: it is not all about the bowel

        ( Ronald Keller ),( Nazar Mazurak ),( Laura Fantasia ),( Stefano Fusco ),( Nisar P Malek ),( Jan Wehkamp ),( Paul Enck ),( Thomas Klag ) 대한장연구학회 2021 Intestinal Research Vol.19 No.1

        Background/Aims: The inflammatory bowel diseases (IBD), ulcerative colitis (UC), and Crohn’s disease (CD) are chronic diseases mostly affecting young patients. As they are diseases accompanying patients for their entire life, and the quality of life (QUOL) interacts with disease activity, improving QUOL should be one of the main goals of therapy. This study aims to identify factors contributing to good or impaired QUOL. Methods: Questionnaires addressing health-related QUOL and other psychological and social features were positioned on our institutions’ webpage and on the webpage of the largest self-help group for IBD in Germany. Patients were subdivided according to their QUOL score with a cutoff of <60. We used the Short Inflammatory Bowel Disease Questionnaire, the Assessment of the Demand for Additional Psychological Treatment, and the Fear of Progression Questionnaire Short Form. Results: High numbers of patients in both subgroups showed an impaired QUOL (87.34% in UC, 91.08% in CD). Active extraintestinal manifestations, smoking, high fear of progression and high demand for psychotherapy were associated with reduced QUOL. In addition, polypharmacological interventions did not result in a good QUOL, but ostomies are linked to improved QUOL especially in CD patients. Conclusions: Scores used in clinical day-to-day-practice mainly focusing on somatic factors do not sufficiently address important aspects concerning QUOL. Most importantly, extraintestinal manifestations show a hitherto underestimated impact on QUOL. (Intest Res 2021;19:45-52)

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        Preconcentration of cadmium and manganese in biological samples based on a novel restricted access sorbents

        Faheem Shah,Naeemullah,Tasneem Gul Kazi,Rafaqat Ali Khan,Murtaza Sayed,Hassan Imran Afridi,Khizar Hussain Shah,Jan Nisar 한국공업화학회 2017 Journal of Industrial and Engineering Chemistry Vol.48 No.-

        A novel restricted access sorbents based micro solid phase extraction (RAS-mSPE) for the extraction ofheavy metal from biological samples has been developed. Cadmium (Cd) and manganese (Mn) weredirectly extracted skipping the tedious, time consuming and expensive sample preparation stepexcluding all of the existing proteins. Sorbent’s (activated carbon cloths) surface was modified withbovine serum albumin through glutaraldehyde to make restricted access sorbent (RAS). Differentvariables affecting the extraction efficiency were selected for optimization. The limits of detectionobtained for Cd and Mn were 0.252 and 0.214 mg L 1, respectively. Analyte recoveries in fortified humanwhole blood serum and milk samples were found in the range of 90.3–103.9%. The procedure waseffectively used for Cd and Mn extraction in real samples devoid of any pretreatment step.

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