Search

Your search keyword '"Feutren G."' showing total 140 results
Start Over Author "Feutren G."
140 results on '"Feutren G."'

5. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3

Author

Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM, B2202 Study Team, ANDREONE, PIETRO, Pianko, S, Zeuzem, S, Chuang, WL, Foster, GR, Sarin, SK, Flisiak, R, Lee, CM, Andreone, P, Piratvisuth, T, Shah, S, Sood, A, George, J, Gould, M, Komolmit, P, Thongsawat, S, Tanwandee, T, Rasenack, J, Li, Y, Pang, M, Yin, Y, Feutren, G, Jacobson, IM, Craxi, A, Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM, and B2202 Study Team.

Subjects
Adult, Male, ANTIVIRAL TREATMENT, Genotype, Interleukins, Interferon-alpha, Hepacivirus, Hepatitis C, Chronic, Middle Aged, Viral Load, Antiviral Agents, Albinterferon alfa-2b, Treatment Outcome, Albumins, Humans, RNA, Viral, Female, Interferons, hepatitis C, hepatitis c
Abstract

Albinterferon alfa-2b (albIFN) is a fusion protein of recombinant human albumin/recombinant interferon (IFN)-α-2b, with ∼200-h half-life. Safety/efficacy of albIFN q4wk was evaluated in 391 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 2/3. Patients were randomized 3:4:4:4 to one of four open-label treatment groups: pegylated IFN (Peg-IFN)-α-2a 180 μg qwk or albIFN 900, 1200 or 1500 μg q4wk, plus oral ribavirin 800 mg/day, for 24 weeks. Primary efficacy endpoint was sustained virologic response (SVR; HCV RNA

Published
2012

9. European trial of cyclosporine in chronic active Crohn's disease: A 12-month study

Author

Wood Aj, Stange Ef, Smith Pr, Modigliani R, Peña As, and Feutren G

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, medicine.disease, Placebo, Confidence interval, Surgery, Pharmacotherapy, Prednisone, Internal medicine, Cohort, medicine, business, Prospective cohort study, Cohort study, medicine.drug
Abstract

Background & Aims: The role of cyclosporine in Crohn's disease is controversial. This study aimed to delineate the long-term effect of cyclosporine in chronic active Crohn's disease. Methods: One hundred eighty-two patients from 33 European centers were included. The patient cohort was stratified at entry into a stratum with low Crohn's Disease Activity Index (CDAI) ( 200). The low-activity group continued to receive the pretrial steroid dose for 2 months, and the high-activity group received 1 mg · kg −1 · day −1 prednisone initially. During months 3 and 4, the dose of steroids was reduced stepwise to 5 mg/day in all patients. Placebo and cyclosporine (5 mg · kg −1 · day −1 ) were administered throughout the 12-month study period. The main parameter of efficacy was the CDAI, and the main end point was the number of patients in remission at month 12. Results: During cyclosporine therapy, 35% (95% confidence interval [95% CI], 25%–46%) of the patients achieved a full remission (CDAI, P > 0.05). At month 12, only 20% (95% CI, 12%–31%) vs. 20% (95% CI, 12%–31%) of the patients had maintained a continuous remission. No major differences between treatment groups were found within each of the two strata. Conclusions: The long-term treatment of chronic active Crohn's disease with cyclosporine plus low-dose steroids does not offer an advantage compared with low-dose steroids alone.

Published
1995

10. Decline in pulmonary function during chronic hepatitis C virus therapy with modified interferon alfa and ribavirin.

Author

Brown K.K., Tanwandee T., Rasenack J., Sola R., Messina I., Yin Y., Cammarata S., Feutren G., Foster G.R., Zeuzem S., Pianko S., Sarin S.K., Piratvisuth T., Shah S., Andreone P., Sood A., Chuang W.-L., Lee C.-M., George J., Gould M., Flisiak R., Jacobson I.M., Komolmit P., Thongsawat S., Brown K.K., Tanwandee T., Rasenack J., Sola R., Messina I., Yin Y., Cammarata S., Feutren G., Foster G.R., Zeuzem S., Pianko S., Sarin S.K., Piratvisuth T., Shah S., Andreone P., Sood A., Chuang W.-L., Lee C.-M., George J., Gould M., Flisiak R., Jacobson I.M., Komolmit P., and Thongsawat S.

Abstract

Rare interstitial lung disease cases have been reported with albinterferon alfa-2b (albIFN) and pegylated interferon alfa-2a (Peg-IFNalpha-2a) in chronic hepatitis C virus (HCV) patients. Systematic pulmonary function evaluation was conducted in a study of albIFN q4wk vs Peg-IFNalpha-2a qwk in patients with chronic HCV genotypes 2/3. Three hundred and ninety-one patients were randomly assigned 4:4:4:3 to one of four, open-label, 24-week treatment groups including oral ribavirin 800 mg/d: albIFN 900/1200/1500 mug q4wk or Peg-IFNalpha-2a 180 mug qwk. Standardized spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) were recorded at baseline, weeks 12 and 24, and 6 months posttreatment, and chest X-rays (CXRs) at baseline and week 24. Baseline spirometry and DLCO were abnormal in 35 (13%) and 98 (26%) patients, respectively. Baseline interstitial CXR findings were rare (4 [1%]). During the study, clinically relevant DLCO declines (<=yen;15%) were observed in 173 patients (48%), and were more frequent with Peg-IFNalpha-2a and albIFN 1500 mug; 24 weeks posttreatment, 57 patients (18%) still had significantly decreased DLCO, with a pattern for greater rates with albIFN vs Peg-IFNalpha-2a. One patient developed new interstitial CXR abnormalities, but there were no clinically relevant interstitial lung disease cases. The risk of persistent posttreatment DLCO decrease was not related to smoking, alcohol, HCV genotype, sustained virologic response, or baseline viral load or spirometry. Clinically relevant DLCO declines occurred frequently in chronic HCV patients receiving IFNalpha/ribavirin therapy and commonly persisted for <=yen;6 months posttherapy. The underlying mechanism and clinical implications for long-term pulmonary function impairment warrant further research. © 2013 Blackwell Publishing Ltd.

Published
2013

11. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3.

Author

Pang M., Li Y., Yin Y., Jacobson I.M., Feutren G., Pianko S., Zeuzem S., Chuang W.-L., Foster G.R., Sarin S.K., Flisiak R., Lee C.-M., Andreone P., Piratvisuth T., Shah S., Sood A., George J., Gould M., Komolmit P., Thongsawat S., Tanwandee T., Rasenack J., Pang M., Li Y., Yin Y., Jacobson I.M., Feutren G., Pianko S., Zeuzem S., Chuang W.-L., Foster G.R., Sarin S.K., Flisiak R., Lee C.-M., Andreone P., Piratvisuth T., Shah S., Sood A., George J., Gould M., Komolmit P., Thongsawat S., Tanwandee T., and Rasenack J.

Abstract

Albinterferon alfa-2b (albIFN) is a fusion protein of recombinant human albumin/recombinant interferon (IFN)-alpha-2b, with a200-h half-life. Safety/efficacy of albIFN q4wk was evaluated in 391 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 2/3. Patients were randomized 3:4:4:4 to one of four open-label treatment groups: pegylated IFN (Peg-IFN)-alpha-2a 180 mug qwk or albIFN 900, 1200 or 1500 mug q4wk, plus oral ribavirin 800 mg/day, for 24 weeks. Primary efficacy endpoint was sustained virologic response (SVR; HCV RNA <20 IU/mL 24 weeks post-treatment). SVR rates were as follows: 85%, 76%, 76% and 78% with Peg-IFNalpha-2a and albIFN 900, 1200 and 1500 mug, respectively (P = NS); corresponding rapid virologic response rates (HCV RNA <43 IU/mL at week 4) were as follows: 78%, 49% (P < 0.001), 60% (P = 0.01) and 71%. SVR rates were not influenced by interleukin 28B genotype, although rapid virologic response rates were greater with interleukin 28B CC (P = NS). Serious adverse event rates were as follows: 4%, 11%, 3% and 3% with Peg-IFNalpha-2a and albIFN 900, 1200 and 1500 mug, respectively. No increase in serious/severe respiratory events was noted with albIFN. Fewer absolute neutrophil count reductions <750/mm3 occurred with albIFN (P = 0.03), leading to fewer IFN dose reductions. Haemoglobin reductions <10 g/dL were less frequent with albIFN 900 and 1200 mug vs 1500 mug and Peg-IFNalpha-2a (P = 0.02), leading to fewer ribavirin dose reductions. albIFN administered q4wk produced fewer haematologic reductions than Peg-IFNalpha-2a, but had numerically lower SVR rates (P = NS) in patients with chronic HCV genotype 2/3. © 2012 Blackwell Publishing Ltd.

Published
2012

12. Safety and efficacy of albinterferon-alfa-2B every four weeks plus ribavirin for treatment of chronic hepatitis C genotype 2/3.

Author

Yin Y., Pianko S., Piratvisuth T., Feutren G., Jacobson I.M., Zeuzem S., Foster G.R., Bain V., Chuang W.-L., Sarin S.K., Flisiak R., Lee C.-M., Shah S.R., Andreone P., Yin Y., Pianko S., Piratvisuth T., Feutren G., Jacobson I.M., Zeuzem S., Foster G.R., Bain V., Chuang W.-L., Sarin S.K., Flisiak R., Lee C.-M., Shah S.R., and Andreone P.

Abstract

Background: Albinterferon-alfa-2b (albIFN) is a fusion protein of recombinant human albumin and rIFN-alpha2b with a half-life of 8 days. An active controlled study evaluated the safety and efficacy of albIFN q4w in treatment-naive patients with chronic HCV-2-3 hepatitis. Method(s): 391 patients were randomized 4:4:4:3 to one of 4 open-label treatment groups, in combination with oral ribavirin 800 mg/d: albIFN q4wks 900mug, 1200mug or 1500mug (6 injections) or PEG-IFNalpha2a 180mug q1wk (24 injections) for 24 weeks. An interim safety evaluation was conducted after all patients had completed the end of treatment while the interim efficacy endpoint was HCV RNA < LOD (20 IU/mL) at week 12 after end of treatment (SVR12). Patients were enrolled at 55 sites in Europe, Asia, Australia and Canada. Result(s): Rates of treatment discontinuation due to adverse events were 1.0%, 2.9%, 3.8%, and 1.3% in the alb- IFN 900mug, 1200mu g, 1500mug and PEG-IFNalpha2a groups respectively (p=NS). Serious AEs occurred in 4.9%, 2.9%, 2.9%, and 2.6% respectively (p=NS). No statistically significant increase in serious or severe respiratory events was noted in any albIFN arm as compared to PEG-IFNalpha2a. Rates of cough on albIFN were 21.6%, 21.4% and 26.7% respectively vs 19.2% on PEG-IFNalpha2a (p=NS). Rates of alopecia were 35.3%, 37.9%, 47.6% and 28.2% respectively (p=0.05). Overall, there were fewer hematology reductions on albIFN, leading to fewer IFN and ribavirin dose reductions. ANC reductions <750/mm3 were 5.0%, 13.7% and 8.6% for albIFN 900mug, 1200mug, 1500mug groups vs 17.9% on PEG-IFNalpha 2a (p=0.0279) while hemoglobin reductions <10g/dL were 11.9%, 18.4% 28.6% vs 25.6% respectively (p=0.0175). SVR 12 rates were 76%, 75%, 81% for albIFN 900mug, 1200mug and 1500mug, vs 82% for PEG-IFNalpha2a (intent to treat; p=NS). Corresponding rates of Rapid Virologic Response at week 4 (HCV RNA < 43 IU/mL) were respectively 49% (p<0.0001 vs PEG-IFNalpha2a) 60% (p=0.01), 71% (p=NS) vs 78% for

Published
2011

13. Final results of ACHIEVE-1: Albinterferon alfa-2b plus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.

Author

Roberts S., Feutren G., Subramanian M., Lurie Y., Baruch Y., Leggett B., Hughes B., Shouval D., Pianko S., Crawford D., Bell S., George J., Safadi R., Mollison L., Roberts S., Feutren G., Subramanian M., Lurie Y., Baruch Y., Leggett B., Hughes B., Shouval D., Pianko S., Crawford D., Bell S., George J., Safadi R., and Mollison L.

Abstract

Background/Aims: ACHIEVE-1 - a phase 3, randomized, active-controlled, multicenter study - evaluated the efficacy and safety of albinterferon alfa-2b (albIFN), a genetic fusion polypeptide of albumin and interferon alfa-2b, in patients with genotype 1 chronic hepatitis C (CHC). Method(s): In all, 1,323 patients were randomized 1:1:1 to one of three treatment groups: peginterferon alfa-2a (PEG-IFNa-2a) 180 mug qwk, and albIFN 900 and 1,200 mug q2wk for 48 weeks, combined with weight-based oral ribavirin 1,000-1,200 mg/d. Randomization was stratified by baseline HCV-RNA >= vs. <800,000 IU/mL, body mass index >= vs. <25 kg/m2, and Black/African heritage versus other. Primary endpoint: sustained virologic response (SVR; HCV-RNA <15 IU/mL at wk 72). The sample size provided 90% power to demonstrate noninferiority with a margin of 12%. Result(s): ACHIEVE-1 demonstrated the noninferiority of albIFN 900 mug (P <.001) and 1,200 mug (P =.003) q2wk vs. PEG-IFNalpha-2a 180 mug qwk for SVR. By intention-to-treat analysis, SVR rates were 51.0, 48.2, and 47.3% with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug, respectively. Consistent with previous studies, multivariate analysis identified the following predictors of SVR: HCV-RNA <400,000 IU/mL, age <45 years, normal c-glutamyl transferase, high alanine aminotransaminase, fibrosis score 0-2, and non-Black race. Respective serious and severe adverse event (AE) rates, and discontinuation rates due to AEs with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug: 10.9, 11.1, and 13.6; 19.5, 20.6, and 24.1; and 4.1, 10.4, and 10.0%. Severe or serious pulmonary AEs were rare. Mortality rates were 1/441, 0/442, and 2/440 with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug, respectively. The rates of hematologic abnormalities were numerically lower with albIFN 900 mug versus PEG-IFNalpha-2a. Conclusion(s): Treatment with albIFN 900 mug q2wk demonstrated comparable efficacy to PEG-IFNalpha-2a 180 mug qwk in patients with genotype 1 CHC, with a s

Published
2010

14. Final results of ACHIEVE-2/3: Albinterferon alfa-2b plus ribavirin in treatment-naive patients with genotype 2/3 chronic hepatitis C.

Author

Cho M., Sheen I.S., Safadi R., Shah S.R., Tanwandee T., Mahachai V., Kuo H.T., Feutren G., Subramanian G., Pianko S., George J., Chuang W.L., Lee C.M., Thongsawat S., Peng C.Y., Shanmuganathan G., Cho M., Sheen I.S., Safadi R., Shah S.R., Tanwandee T., Mahachai V., Kuo H.T., Feutren G., Subramanian G., Pianko S., George J., Chuang W.L., Lee C.M., Thongsawat S., Peng C.Y., and Shanmuganathan G.

Abstract

Background/Aims: ACHIEVE-2/3 - a phase 3, randomized, active-controlled, multicenter study - evaluated the efficacy and safety of albinterferon alfa-2b (albIFN), a genetic fusion polypeptide of albumin and interferon alfa-2b, in patients with genotype 2/3 chronic hepatitis C (CHC). Method(s): In all, 932 patients were randomized 1:1:1 to one of three treatment groups: peginterferon alfa-2a (PEG-IFNalpha-2a) 180 mug qwk, and albIFN 900 and 1,200 mug q2wk for 24 weeks, combined with oral ribavirin 800 mg/d. Randomization was stratified by baseline HCV-RNA >= versus <800,000 IU/mL and genotype 2 versus 3. Primary endpoint: sustained virologic response (SVR; HCV-RNA <15 IU/mL at wk 48). The sample size provided 90% power to demonstrate noninferiority (margin of 12%). Result(s): ACHIEVE-2/3 demonstrated the SVR noninferiority of albIFN 900 mug (P = 0.009) and 1,200 mug (P = 0.006) q2wk versus PEG-IFNalpha-2a 180 mug qwk. By intention-to-treat analysis, SVR rates were 84.8, 79.82, and 80.0% with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug, respectively. Consistent with previous studies, multivariate analysis identified HCV-RNA <400,000 IU/mL, age <45, BMI <30, genotype 2, normal gamma-glutamyl transferase, high alanine aminotransaminase, no steatosis, fibrosis score 0-2, and Asian region (for PEG-IFNalpha-2a only) as SVR predictors. In the Asian region (n = 271), SVR rates were 95.5, 79.8, and 81.8% with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug, respectively, versus 80.5, 79.8, and 79.3% in all other regions (n = 662). The incidence of serious (7-8%) or severe (13-16%) AEs, or death (0.3-0.6%) was similar across groups. Discontinuation rates due to AEs were 3.6, 4.8, and 5.5% with PEG-IFNalpha-2a, and albIFN 900 and 1,200 mug, respectively. Severe/serious pulmonary infections and interstitial lung disease were rare, with similar rates across groups. Conclusion(s): ACHIEVE-2/3 demonstrated that albIFN 900 mug q2wk was comparable in efficacy to PEG-IFNalpha-2a 180 mu

Published
2010

15. Towards a Gold Standard for Adherence Assessment in Transplantation: High Accuracy of the Proteus Raisin System (PRS) Combined with Enteric-Coated Mycophenolate Sodium (ECMPS) in Stable Kidney Transplant Recipients

Author

Wüthrich, R. P., primary, Eisenberger, U., additional, Bock, A., additional, Ambühl, P., additional, Steiger, J., additional, Intondi, A., additional, Kuranoff, S., additional, Maier, T., additional, Green, D., additional, Feutren, G., additional, and De Geest, S., additional

Published
2012
Full Text
View/download PDF

16. 424 RESPIRATORY ALTERATIONS IN GENOTYPE 2/3 CHRONIC HEPATITIS C PATIENTS TREATED WITH PEGYLATED INTERFERON OR ALBINTERFERON-ALFA-2B PLUS RIBAVIRIN IN A RANDOMIZED STUDY

Author

Foster, G., primary, Flisiak, R., additional, Chuang, W.-L., additional, George, J., additional, Rasenack, J., additional, Sood, A., additional, Komolmit, P., additional, Thongsawat, S., additional, Tanwandee, T., additional, Sola, R., additional, Sukeepaisarnjaroen, W., additional, Weltman, M., additional, Yin, Y., additional, Feutren, G., additional, and Brown, K., additional

Published
2011
Full Text
View/download PDF

19. Efficacy and tolerability of multiple-dose SDZ IMM 125 in patients with severe psoriasis

Author

WITKAMP, L., primary, ZONNEVELD, I. M., additional, JUNG, E. G., additional, SCHOPF, R. E., additional, CHRISTOPHERS, E., additional, GROSSMAN, R., additional, MEFFERT, H., additional, BELAICH, S., additional, MAHRLE, G., additional, JOOST, TH., additional, STOOF, T., additional, BOS, J. D., additional, MAYER, H., additional, TAESCH, S., additional, and FEUTREN, G., additional

Published
2006
Full Text
View/download PDF

31. Risk factors for cyclosporine-induced nephropathy in patients with autoimmune diseases.

Author

Feutren, G. and Mihatsch, M.J.

Subjects
*DISEASES
Abstract

Presents a study that concludes that nephropathy is an important potential effect of cyclosporine therapy. How to minimize the risk of its development in patients with autoimmune diseases who are treated with cyclosporine; Characteristics of patients with autoimmune or inflammatory diseases treated with cyclosporine; Incidence and features of cyclosporine-induced nephropathy; Sjogren's syndrome; Behcet's syndrome; More.

Published
1992
Full Text
View/download PDF

36. Efficacy and tolerability of multiple -- dose SDZ IMM 125 in patients with severe psoriasis.

Author

Witkamp, L., Zonneveld, I. M., Jung, E. G., Schopf, R. E., Christophers, E., Grossman, R., Meffert, H., Belaich, S., Mahrle, G., Van Joost, Th., Stoff, T., Bos, J. D., Mayer, H., Taesch, S., and Feutren, G.

Subjects
CYCLOSPORINE, IMMUNOSUPPRESSIVE agents, DRUG efficacy, PSORIASIS, SKIN diseases, DERMATOLOGY
Abstract

Although cyclosporin is effective in immunosuppression following organ transplantation and in the treatment of psoriasis, its use is limited by its side-effects, notably impaired renal function and hypertension. As SDZ IMM 125, a new derivative of the cyclosporin family, showed considerable immunosuppressive activity in experimental studies, with less effect on renal function, it was considered a potential successor to cyclosporin for both indications. In this multicentre, double-blind, placebo-controlled study, the efficacy and tolerability of 40, 100, 200 and 400 mg SDZ IMM 125 daily were studied in 59 patients with psoriasis. Patients were followed for a period of 5 weeks (4 weeks treatment, and 1 week post-treatment observation). A dose-dependent effect of SDZ IMM 125 was observed. A significant correlation was found between the dose of SDZ IMM 125 and changes in the sum of severity scores of three indicator plaques. There was a significant decrease in the body surface area affected by psoriasis in the 400-mg group (P ≤ 0.01), whereas a decrease of the global psoriasis severity was observed in the 200-mg (P ≤ 0.01) and the 400-mg groups (P ≤ 0.001). No serious adverse events occurred during the 4 weeks of treatment. Three patients discontinued treatment because of adverse events (one sore throat, two influenza). Clinical adverse events were similar to those reported with cyclosporin, the most frequent being gastrointestinal disturbances. Estimation of renal function indices showed that increases from baseline values were dose-dependent, and appeared to be similar to those seen with cyclosporin. Changes in liver function tests showed a clearcut dose-dependent increase of some liver enzymes, principally alanine aminotransferase (ALAT). SDZ IMM 125 is effective in clearing psoriasis. However, long-term studies comparing the efficacy and safety of SDZ IMM 125 and cyclosporin must be performed, to determine whether SDZ IMM 125 has a better risk-benefit ratio than cyclosporin. [ABSTRACT FROM AUTHOR]

Published
1995
Full Text
View/download PDF

37. Kidney biopsies in control or cyclosporin A- treated psoriatic patients.

Author

Mihatsch, M.J., Belghiti, D., Bohman, S.O., Porter, K., Dubertret, L., Fry, L., Juhlin, L., Zachariae, H., and Feutren, G.

Subjects
RENAL biopsy, PATIENTS, CYCLOSPORINE, PSORIASIS treatment products, DERMATOLOGIC agents, PSORIASIS, SKIN diseases, DERMATOLOGY
Abstract

Kidney biopsies were obtained from 14 adult patients treated with cyclosporin A (CyA) for psoriasis. These biopsies were compared with those from 16 psoriatic patients of the same age, but who were not receiving treatment with CyA. Patients receiving CyA had a maximum mean dose of 5&middot1 mg/kg/day for a mean duration of 15 months (range 3–37 months). Minimal or slight interstitial fibrosis, tubular atrophy or arteriolopathy were seen in the biopsies of patients receiving CyA as well as in those of the controls. No relevant CyA-related structural alterations of the kidney were detected. [ABSTRACT FROM AUTHOR]

Published
1990
Full Text
View/download PDF

38. Effect of cyclosporin A treatment on the production of antibody in insulin-dependent (type I) diabetic patients

Author

J. Hors, Feutren G, Jean-Marie Bach, Christian Boitard, L Castano, M Debray-Sachs, and Roger Assan

Subjects
Cytotoxicity, Immunologic, medicine.medical_specialty, medicine.medical_treatment, Thyroid Gland, Cyclosporins, Immunofluorescence, Placebos, Pathogenesis, Islets of Langerhans, Random Allocation, Antigen, Cyclosporin a, Internal medicine, medicine, Humans, Insulin, Autoantibodies, Clinical Trials as Topic, geography, geography.geographical_feature_category, biology, medicine.diagnostic_test, business.industry, Autoantibody, General Medicine, Islet, Diabetes Mellitus, Type 1, Endocrinology, Antibody Formation, biology.protein, Antibody, business, Research Article
Abstract

Anti-islet cell and anti-insulin antibody production was studies over a 12-mo period in 82 recently diagnosed diabetics randomly receiving either cyclosporin or placebo. Cyclosporin had only minimal effects on the production of anti-islet cell antibodies whether directed to islet cytoplasmic (immunofluorescence) or membrane (cytotoxicity assay) antigens even in patients undergoing remission. These data suggest that these antibodies do not play a major role in the pathogenesis of the disease particularly since their (irregular) presence is not predictive of the clinical response to cyclosporin. Conversely, cyclosporin completely suppressed the synthesis of antibodies elicited by exogenous insulin irrespective of the insulin doses received, and decreased the autoantibody production against thyroid antigens, indicating that cyclosporin has variable effects on antibody production against various antigens.

Published
1987

39. METABOLIC AND IMMUNOLOGICAL EFFECTS OF CYCLOSPORIN IN RECENTLY DIAGNOSED TYPE 1 DIABETES MELLITUS

Author

Assan, R., Debray-Sachs, M., Laborie, C., Chatenoud, L., Feutren, G., Quiniou-Debrie, M.C., Thomas, G., and Bach, J.F.

Abstract

Cyclosporin 5-10 mg/kg daily was given for 2-8 months to twelve recently diagnosed type 1 diabetics from a mean of 49±SE 14 days after the start of insulin therapy, which was regulated to give near-normal blood glucose and haemoglobin A1cvalues. Mean insulin dosage dropped from 46±5 U/day before cyclosporin treatment to 16±4 U/day by the 7th month. Four patients had a complete remission and the insulin needs of four more were cut by half. The remaining four did not have remissions. Initial basal and glucagon-stimulated C peptide concentrations were higher in those who went into remission than in those who did not; they rose during cyclosporin treatment in the former but not in the latter. OKT4+lymphocyte functions were suppressed in all patients and OKT4/OKT8 ratios declined. Anti-beta-cell autoimmunity, as indicated by lymphocyte-induced inhibition of insulin release from mouse islet cells, declined in all patients who went into remission. No consistent trend was observed for anti-islet cell antibodies. In forty-four similar, but non-randomised, recently diagnosed diabetics treated with insulin alone, the incidence of remission was 6%.

Published
1985
Full Text
View/download PDF

47. Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants.

Author

Eisenberger U, Wüthrich RP, Bock A, Ambühl P, Steiger J, Intondi A, Kuranoff S, Maier T, Green D, DiCarlo L, Feutren G, and De Geest S

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Mycophenolic Acid therapeutic use, Tablets, Enteric-Coated, Immunosuppressive Agents therapeutic use, Kidney Transplantation, Medication Adherence, Mycophenolic Acid analogs & derivatives
Abstract

Background: This open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence., Methods: ISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days., Results: Eight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376)., Conclusions: ISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.

Published
2013
Full Text
View/download PDF

48. Normal renal function 8 to 13 years after cyclosporin A therapy in 285 diabetic patients.

Author

Assan R, Blanchet F, Feutren G, Timsit J, Larger E, Boitard C, Amiel C, and Bach JF

Subjects
Adult, Creatinine blood, Cyclosporine administration & dosage, Diabetes Mellitus, Type 1 physiopathology, Female, Follow-Up Studies, Glomerular Filtration Rate drug effects, Humans, Hypertension chemically induced, Immunosuppressive Agents therapeutic use, Inulin pharmacokinetics, Kidney physiopathology, Kidney Diseases pathology, Kidney Function Tests, Male, Pregnancy, Proteinuria chemically induced, Time Factors, Vascular Resistance drug effects, Autoimmune Diseases drug therapy, Cyclosporine toxicity, Diabetes Mellitus, Type 1 drug therapy, Immunosuppressive Agents toxicity, Kidney drug effects, Kidney Diseases chemically induced
Abstract

Background: Cyclosporin A (CyA) may induce acute nephrotoxicity. The question has been raised of the possible long-term unfavorable course of CyA-induced lesions. Advantage was taken of a large cohort of diabetic patients treated for several months using moderate CyA dosage to evaluate the long-term evolution of renal function in such patients., Methods: Two hundred and eighty five recently diagnosed type 1 diabetic patients having received CyA for a mean of 19.9 months were monitored for 13 years, in parallel with 100 similar patients treated with insulin alone., Results: In the CyA-treated group, a transient increase in creatininemia levels occurred during the first 18 months of treatment associated with a transient increase in renal vascular resistance. Both effects disappeared later on: creatininemia levels then remained normal. Inulin and p-aminohippurate (PAH) clearances remained normal throughout follow-up. Neither permanent renal failure nor progressive deterioration of renal function occurred in either group or in individual patients. A 10 to 12% increase in inulin and PAH clearance was elicited by IV amino acid infusion at 7 to 10 years, a finding consistent with a normal renal functional reserve. Patients with moderate kidney lesions on biopsy at 1 year had normal and stable clearance values at 7 to 13 years. The prevalence of arterial hypertension and retinopathy was lower in the CyA-treated group than in the control group, possibly because of the tighter metabolic control obtained in the CyA group., Conclusion: These results suggest that low-dose CyA treatment combined with thorough monitoring does not result in long-term renal dysfunction., (Copyright 2002 John Wiley & Sons, Ltd.)

Published
2002
Full Text
View/download PDF

49. Safety and tolerability of Neoral in transplant recipients.

Author

Feutren G, Wong R, Jin J, Niese D, and Mellein B

Subjects
Administration, Oral, Adult, Aged, Azathioprine therapeutic use, Cyclosporine administration & dosage, Cyclosporine pharmacokinetics, Double-Blind Method, Female, Humans, Immunosuppressive Agents administration & dosage, Immunosuppressive Agents therapeutic use, Male, Metabolic Clearance Rate, Middle Aged, Steroids therapeutic use, Cyclosporine adverse effects, Immunosuppressive Agents adverse effects, Kidney Transplantation immunology, Liver Transplantation immunology
Published
1996

50. European trial of cyclosporine in chronic active Crohn's disease: a 12-month study. The European Study Group.

Author

Stange EF, Modigliani R, Peña AS, Wood AJ, Feutren G, and Smith PR

Subjects
Adolescent, Adult, Chronic Disease, Cohort Studies, Crohn Disease blood, Cyclosporine administration & dosage, Cyclosporine pharmacokinetics, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Europe, Female, Humans, Male, Middle Aged, Prednisone administration & dosage, Prednisone therapeutic use, Prospective Studies, Remission Induction, Crohn Disease drug therapy, Cyclosporine therapeutic use
Abstract

Background & Aims: The role of cyclosporine in Crohn's disease is controversial. This study aimed to delineate the long-term effect of cyclosporine in chronic active Crohn's disease., Methods: One hundred eighty-two patients from 33 European centers were included. The patient cohort was stratified at entry into a stratum with low Crohn's Disease Activity Index (CDAI) ( < 200) and high CDAI ( > 200). The low-activity group continued to receive the pretrial steroid dose for 2 months, and the high-activity group received 1 mg.kg-1.day-1 prednisone initially. During months 3 and 4, the dose of steroids was reduced stepwise to 5 mg/day in all patients. Placebo and cyclosporine (5 mg.kg-1.day-1) were administered throughout the 12-month study period. The main parameter of efficacy was the CDAI, and the main end point was the number of patients in remission at month 12., Results: During cyclosporine therapy, 35% (95% confidence interval [95% Cl], 25%-46%) of the patients achieved a full remission (CDAI, < 150) after 4 months compared with 27% (95% Cl, 18%-38%) in the placebo group (P > 0.05). At month 12, only 20% (95% Cl, 12%-31%) vs. 20% (95% Cl, 12%-31%) of the patients had maintained a continuous remission. No major differences between treatment groups were found within each of the two strata., Conclusions: The long-term treatment of chronic active Crohn's disease with cyclosporine plus low-dose steroids does not offer an advantage compared with low-dose steroids alone.

Published
1995
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results