The Experts below are selected from a list of 273 Experts worldwide ranked by ideXlab platform
Jean-frédéric Colombel - One of the best experts on this subject based on the ideXlab platform.
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subcutaneous golimumab maintains Clinical Response in patients with moderate to severe ulcerative colitis
Gastroenterology, 2014Co-Authors: William J. Sandborn, Omoniyi J Adedokun, Jewel Johanns, Cynthia Guzzo, Brian G. Feagan, Richard Strauss, Claudia Marano, Hongyan Zhang, Jean-frédéric ColombelAbstract:Background & Aims Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα antagonist-naive adults with moderate-to-severe active ulcerative colitis, despite conventional therapy, who responded to golimumab induction therapy. Methods We performed a phase 3, double-blind trial of patients who completed golimumab induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to induction therapy with golimumab (n = 464) were assigned randomly to groups given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 52. Patients who responded to placebo in the induction study continued to receive placebo. Nonresponders in the induction study received 100 mg golimumab. The primary end point was Clinical Response maintained through week 54; secondary end points included Clinical remission and mucosal healing at both weeks 30 and 54. Results Clinical Response was maintained through week 54 in 47.0% of patients receiving 50 mg golimumab, 49.7% of patients receiving 100 mg golimumab, and 31.2% of patients receiving placebo ( P = .010 and P P = .004 and P = .002, respectively) or 50 mg golimumab (23.2% and 41.7%, respectively). Percentages of serious adverse events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 3.2%, respectively. Among all patients given golimumab in the study, 3 died (from sepsis, tuberculosis, and cardiac failure, all in patients who received 100 mg golimumab) and 4 developed active tuberculosis. Conclusions Golimumab (50 mg or 100 mg) maintained Clinical Response through week 54 in patients who responded to induction therapy with golimumab and had moderate-to-severe active ulcerative colitis; patients who received 100 mg golimumab had Clinical remission and mucosal healing at weeks 30 and 54. Safety was consistent with that reported for other TNFα antagonists and golimumab in other approved indications. ClinicalTrials.gov number: NCT00488631.
Carlomaurizio Montecucco - One of the best experts on this subject based on the ideXlab platform.
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high iga rheumatoid factor levels are associated with poor Clinical Response to tnf α inhibitors in rheumatoid arthritis
Annals of the Rheumatic Diseases, 2006Co-Authors: Francesca Bobbiopallavicini, Roberto Caporali, Claudia Alpini, Stefano Avalle, O Epis, Catherine Klersy, Carlomaurizio MontecuccoAbstract:Objective: The aim of the present observational longitudinal study was to investigate whether Rheumatoid Factor (RF) isotypes and anti-cyclic citrullinated peptide antibodies (anti-CCP) are related to Clinical Response in rheumatoid arthritis (RA) treated with tumour necrosis factor-α (TNF-α) inhibitors. Methods: The study was carried out on 132 patients with advanced RA refractory to DMARDS. Patients were treated with either Infliximab (63 patients), Etanercept (35) or Adalimumab (34). All patients completed one year of follow up, and 126 were evaluable for Clinical Response according to the disease activity score (DAS) criteria. IgM-, IgA- and IgG-RFs and anti- CCP antibodies were assessed by enzyme linked immunosorbent assay both before anti-TNF-α therapy and one year later. Results: DAS Response was reached in 66% of evaluable patients (61% infliximab, 65% etanercept and 76% adalimumab; p= 0.354). A significant RF level reduction was reported by all treatment groups after one year. The frequency of positive tests for the different antibodies did not differ between responders and non- responders at baseline, however, significantly higher IgA-RF levels were reported by the non-responder group (130.4U/ml [interquartile range:13.8-276.7] vs 24.8 U/ml [10.2-90.8]; p = 0.003). A significant decrease in the levels of all RF isotypes in the responder group was reported after one year of therapy, whilst anti-CCP levels were not significantly affected. Conclusions: According to Clinical Response, anti- TNF-α agents appear to reduce IgM-, IgG-, and IgA- RF levels. More interestingly, high pre-treatment levels of IgA-RF are associated with a poor Clinical Response to TNF-α inhibitors.
William J. Sandborn - One of the best experts on this subject based on the ideXlab platform.
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subcutaneous golimumab maintains Clinical Response in patients with moderate to severe ulcerative colitis
Gastroenterology, 2014Co-Authors: William J. Sandborn, Omoniyi J Adedokun, Jewel Johanns, Cynthia Guzzo, Brian G. Feagan, Richard Strauss, Claudia Marano, Hongyan Zhang, Jean-frédéric ColombelAbstract:Background & Aims Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα antagonist-naive adults with moderate-to-severe active ulcerative colitis, despite conventional therapy, who responded to golimumab induction therapy. Methods We performed a phase 3, double-blind trial of patients who completed golimumab induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to induction therapy with golimumab (n = 464) were assigned randomly to groups given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 52. Patients who responded to placebo in the induction study continued to receive placebo. Nonresponders in the induction study received 100 mg golimumab. The primary end point was Clinical Response maintained through week 54; secondary end points included Clinical remission and mucosal healing at both weeks 30 and 54. Results Clinical Response was maintained through week 54 in 47.0% of patients receiving 50 mg golimumab, 49.7% of patients receiving 100 mg golimumab, and 31.2% of patients receiving placebo ( P = .010 and P P = .004 and P = .002, respectively) or 50 mg golimumab (23.2% and 41.7%, respectively). Percentages of serious adverse events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 3.2%, respectively. Among all patients given golimumab in the study, 3 died (from sepsis, tuberculosis, and cardiac failure, all in patients who received 100 mg golimumab) and 4 developed active tuberculosis. Conclusions Golimumab (50 mg or 100 mg) maintained Clinical Response through week 54 in patients who responded to induction therapy with golimumab and had moderate-to-severe active ulcerative colitis; patients who received 100 mg golimumab had Clinical remission and mucosal healing at weeks 30 and 54. Safety was consistent with that reported for other TNFα antagonists and golimumab in other approved indications. ClinicalTrials.gov number: NCT00488631.
Philip B Paty - One of the best experts on this subject based on the ideXlab platform.
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nonoperative management of rectal cancer with complete Clinical Response after neoadjuvant therapy
Annals of Surgery, 2012Co-Authors: James D Smith, Jeannine A Ruby, Karyn A Goodman, Leonard Saltz, Jose G Guillem, Martin R Weiser, Larissa K Temple, Garrett M Nash, Philip B PatyAbstract:Introduction:Nonoperative management (NOM) of rectal cancer after a complete Clinical Response (cCR) to neoadjuvant therapy is controversial. In this article, we retrospectively reviewed the outcomes of patients managed with selective NOM after a cCR to neoadjuvant treatment and compared these with
Jim Mintz - One of the best experts on this subject based on the ideXlab platform.
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Haloperidol plasma levels and Clinical Response: a therapeutic window relationship.
American Journal of Psychiatry, 1992Co-Authors: Theodore Van Putten, Stephen R. Marder, Jim Mintz, Russell E. PolandAbstract:Objective: The purpose ofthe study was to assess the relationship between plasma haloperidol and Clinical Response. Method: Sixty-nine newly admitted drug-free schizophrenic men were randomly assigned to receive haloperidol, 5, 1 0, or 20 mg daily for 4 weeks, and Clinical Response was measured at the end of the fixed-dose period. Haloperidol was assayed by a sensitive and specific radioimmunoassay. Results: The authors found a curvilinear relationship between Clinical Response and plasma haloperidol during fixed-dose treatment, with an apparent optimum between 5 and 12 ng/ml. When plasma levels above 12 ng/ml were lowered to the 5-1 2 ng/ml range, all patients improved to varying degrees and no patient deteriorated. When plasma levels of nonresponders within this therapeutic window were raised above 12 ng/ml (as in routine practice), they, on balance, deteriorated in that they became more dysphoric. With the 20-mg dose, halfthe patients had plasma levels above 12 ng/ml. Conclusions: In this sample of newly admitted schizophrenic men, optimal Clinical Response occurred with a plasma haloperidol range of5-12 ng/ml. (Am J Psychiatry 1992; 149:500-505)
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Serum prolactin as a correlate of Clinical Response to haloperidol.
Journal of Clinical Psychopharmacology, 1991Co-Authors: T. Van Putten, Stephen R. Marder, Jim MintzAbstract:: The rise in serum prolactin concentration in patients treated with neuroleptic drugs is well documented, but attempts to relate this rise to Clinical Response have yielded conflicting results. These conflicting results could be explained by design flaws in those studies attempting to relate prolactin to Clinical Response. Seventy-three newly (re)admitted drug-free schizophrenic men were randomly assigned to receive haloperidol either 5, 10, or 20 mg daily for 4 weeks. Prolactin levels post-treatment were significantly (p less than 0.02) related to global outcome by logistic regression. A serum prolactin level may be a useful guide to the lowest effective dose of haloperidol in newly treated schizophrenic men. Above a plasma prolactin level of approximately 30 ng/ml there was very little increase in Response. Patients on the 5, 10, and 20 mg daily haloperidol doses had mean prolactin levels of 16, 32, and 34 ng/ml, respectively.
