Anticytokine Therapie für Psoriasis
N Engl J Med ; Comments open through July 3, Moderate-to-severe asthma remains poorly treated. Full Text of Background We administered dupilumab mg or placebo subcutaneously once weekly.
Patients were instructed to discontinue LABAs at week 4 and to taper and discontinue inhaled glucocorticoids during weeks 6 through 9.
Patients received the study drug for 12 weeks or until a protocol-defined asthma exacerbation occurred. The primary end point was the occurrence of an asthma exacerbation; secondary end points included a range of measures of asthma control. Effects on various type 2 helper Anticytokine Therapie für Psoriasis Th2 —associated biomarkers and safety and tolerability were also evaluated. Full Text of Methods A total of 52 patients were assigned to the dupilumab group, and 52 patients were assigned to the placebo group.
Baseline characteristics were similar in the two groups. Significant improvements were observed for most measures of lung function and asthma control.
Dupilumab reduced biomarkers associated with Th2-driven inflammation. Injection-site reactions, nasopharyngitis, nausea, and headache occurred more frequently with dupilumab than with placebo.
Full Text of Results In patients with persistent, moderate-to-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations anticytokine Therapie für Psoriasis LABAs and inhaled glucocorticoids were withdrawn, with improved lung function and reduced levels of Th2-associated inflammatory markers. Funded by Sanofi and Regeneron Pharmaceuticals; ClinicalTrials.
Full Text of Discussion Recent estimates suggest that The clinical syndrome of persistent, moderate-to-severe asthma is increasingly recognized as comprising various phenotypes. The type II receptor, click to see more by interleukin-4 and interleukin, is expressed widely across resident and myeloid cells. The anticytokine Therapie für Psoriasis of this study was to assess the anticytokine Therapie für Psoriasis and safety of dupilumab in adults with persistent, moderate-to-severe asthma and elevated eosinophil levels.
This randomized, double-blind, placebo-controlled, parallel-group phase 2A study was conducted at 28 sites in the United States from March through October A 2-week screening period was followed by a week intervention period and an 8-week follow-up period Figure 1A Figure 1 Study Design and Numbers of Patients Enrolled and Included in the Analysis. Panel A shows the study design, and Panel B the numbers of patients who were assessed, randomly assigned to a study group, and included in the analysis.
BID denotes twice daily, DPI dry-powder inhalation, and MDI metered-dose inhalation. The protocol available with the full text of this article at NEJM. Data were collected by the investigators and analyzed by the sponsors. Although the authors were assisted by an independent medical writer paid by the sponsors, the first draft of the manuscript was written by the first author, with input from all other authors and the sponsors.
The first and last authors made the decision to submit the manuscript for publication. The academic author and the authors who are employees of the sponsors vouch for the accuracy and completeness of the data, the statistical analysis, and the fidelity of the study to the protocol.
During the study, the investigators, participating institutions, and sponsors agreed to maintain data confidentiality. The protocol was approved by the institutional review board of each study site or by a central institutional review board. All patients provided written informed consent.
Details on sputum induction and analysis http://outdoor-frauen.de/stress-verursacht-schuppenflechte.php provided in the Assessment Procedures section in the Supplementary Appendix available at NEJM.
A diagnosis of asthma for at least 12 months was substantiated by the reversibility of the forced expiratory volume in 1 second FEV 1 during anticytokine Therapie für Psoriasis or earlier or by a positive methacholine challenge within 12 months before screening.
For details, see the Study Inclusion anticytokine Therapie für Psoriasis Exclusion Criteria section in the Supplementary Appendix. Patients were randomly assigned in a 1: Injections were administered by investigators or other site personnel who were unaware of the study-group assignments.
This approach enabled us to observe the effects of dupilumab when added to background therapy, after LABA discontinuation, during the http://outdoor-frauen.de/behandlung-von-psoriasis-auf-den-haenden.php of inhaled glucocorticoids, and as monotherapy.
For the purposes of this medication-withdrawal study, an exacerbation was defined as the occurrence of any one of the following: The primary efficacy end point was the anticytokine Therapie für Psoriasis of an asthma exacerbation, as previously defined, during the week intervention period. Secondary end points were the anticytokine Therapie für Psoriasis to an asthma exacerbation read more the change from baseline at each visit and at week 12 in FEV 1morning and evening PEF, ACQ5 score, morning and evening asthma-symptom scores ranging from 0 to 4, with higher scores indicating more severe symptomsnocturnal awakenings, and the number of albuterol or levalbuterol inhalations per day.
All anticytokine Therapie für Psoriasis except for FEV 1 were recorded anticytokine Therapie für Psoriasis an electronic diary and used for the anticytokine Therapie für Psoriasis of lower-airway symptoms.
Participants completed the item Sinonasal Outcome Test SNOT [scores range please click for source 0 toanticytokine Therapie für Psoriasis higher scores indicating poorer outcomes and with 8. Details are provided in the Assessment Procedures section and Table S1 in the Supplementary Appendix. Pharmacodynamic measurements, including Th2-associated biomarkers, were assessed at multiple time points.
These were the fraction of exhaled nitric oxide Fe NOserum biomarkers thymus and activation-regulated chemokine [TARC, or CCL17], IgE, YKL, and carcinoembryonic antigen [CEA]plasma eotaxin-3 CCL26and peripheral-blood eosinophil levels. Details are provided in the Assessment Procedures section in the Supplementary Appendix.
Safety and tolerability were evaluated on the basis of the incidence of adverse events and serious adverse events, as well as vital signs and findings on physical examination, clinical laboratory testing, and lead electrocardiography ECG. Efficacy analyses were performed in the intention-to-treat population, defined as all randomly assigned patients who received at least one dose of the study drug.
For the primary end anticytokine Therapie für Psoriasis, a logistic-regression model was used to compare the two study groups, with study drug and stratification factor prior dose of inhaled glucocorticoids and LABAs included as covariates.
The secondary end point of the time to an asthma exacerbation was analyzed with the use of a log-rank test for comparison of survival distributions between groups. For other secondary end points except the SNOT scorethe change from baseline was evaluated with the use of a mixed-effects model with repeated measures.
The model included change from baseline values up to week 12 as response variables and included factors fixed effects for study drug, stratification factor, visit, interaction between study drug and visit, baseline value, and interaction between baseline value and visit. Statistical inferences on study-drug comparisons for changes from baseline at week 12 were derived from the mixed-effects model.
No imputations for missing data were performed. The change from baseline in the SNOT score was analyzed with the use of an analysis of covariance ANCOVAwith measurements at the end of the intervention period used to impute missing data. Pharmacodynamic effects were evaluated with the use of mixed-effects models with repeated measures in a post hoc fashion. No adjustments were made for multiple comparisons because there was only one primary end point and analysis.
Descriptive statistics were used for demographic and clinical characteristics and for safety variables, including adverse events, vital signs, and findings on physical examination, clinical laboratory testing, and ECG. A total of patients from screened underwent randomization, with 52 assigned to each study group Figure 1B. Three patients qualified only on the basis of elevated anticytokine Therapie für Psoriasis eosinophil levels, and the remainder were eligible on the basis of elevated blood eosinophil levels.
All randomly assigned patients received at least one dose of the study drug and were therefore included in the intention-to-treat population. Demographic and clinical characteristics were similar in the two groups Table 1 Table 1 Baseline Demographic and Clinical Characteristics of the Participants. Asthma exacerbations occurred in 26 patients: The forced expiratory volume in 1 second FEV 1 and the percent of predicted FEV 1 were higher with dupilumab than with placebo over the duration of the study Panel Cand the number of anticytokine Therapie für Psoriasis awakenings was lower Panel D.
The I bars indicate standard errors. No patients were hospitalized for asthma exacerbations. The time to an asthma exacerbation was longer Figure 2B and the risk anticytokine Therapie für Psoriasis exacerbation was reduced with dupilumab as compared with placebo hazard ratio, 0.
For all secondary end points, week measurements favored dupilumab and the between-group differences were significant except for evening PEF, nocturnal awakenings, and some SNOT items Table 2and Table S2 in the Supplementary Appendix. Dupilumab was associated with a significant increase from baseline in percent of predicted FEV 1 and actual FEV 1 at week 2, which was maintained through week 12 Figure 2Cand Table S3 in the Supplementary Appendix despite discontinuation of LABAs and inhaled glucocorticoids, with a small decrease in FEV 1 at week 5 coinciding with discontinuation of LABAs.
Similar improvements were observed in morning PEF with dupilumab, but the improvement in evening PEF was smaller Fig. S1 in the Supplementary Appendix. The ACQ5 score was improved in both study groups at week 1 Fig. S2 anticytokine Therapie für Psoriasis the Supplementary Appendix. Subsequently, the ACQ5 score in the dupilumab group continued to improve, whereas the placebo effect stabilized, with a significant between-group difference by week 3 Table S3 in the Supplementary Appendix that was maintained anticytokine Therapie für Psoriasis week Morning asthma-symptom scores increased from baseline to week 12 with placebo.
With dupilumab, anticytokine Therapie für Psoriasis was an initial decrease, with scores remaining below the baseline score through week 12 Fig. S3A and S3B in the Supplementary Appendix. A similar pattern but with greater variability was observed for evening asthma-symptom scores Fig.
S3C and S3D in the Supplementary Appendix. Nocturnal awakenings were stable with placebo through week 6, then increased between anticytokine Therapie für Psoriasis 6 and In contrast, anticytokine Therapie für Psoriasis awakenings decreased with dupilumab by week 1, and the reduction was maintained and awakenings remained less frequent versus baseline through week 12 Figure 2D.
Changes in the use of albuterol or levalbuterol Fig. S4 in the Supplementary Appendix were similar to those in other secondary end points: With placebo, Fe NO values remained stable through week 8, followed by an increase at week 12 that coincided with discontinuation of inhaled glucocorticoids Figure 3A Figure 3 Values anticytokine Therapie für Psoriasis Key Pharmacodynamic Markers over the Duration of the Study Intention-to-Treat Population.
Shown are the fraction of exhaled nitric oxide Fe NO Panel A and levels of thymus and activation-regulated chemokine TARC Panel Beotaxin-3 Panel Cand IgE Panel D. With dupilumab, Fe NO values were markedly decreased at week 4 and remained below baseline values through week 12, despite discontinuation of inhaled glucocorticoids.
Levels of TARC, eotaxin-3, and IgE Figure 3B, 3C, and 3D remained unchanged with placebo. In contrast, with dupilumab, TARC and eotaxin-3 levels were decreased at week 1 and remained lower than baseline values through week With dupilumab, the IgE level was also lower than the baseline value at week 4, diverging from the value with placebo Figure 3Dand was further decreased at week S5 through S8 in the Supplementary Appendix.
No significant differences from baseline or between study groups were observed in YKL or CEA levels Fig. S9 and S10 in the Supplementary Appendix. Peripheral-blood eosinophil levels were unchanged anticytokine Therapie für Psoriasis placebo throughout the intervention period.
With dupilumab, the majority of patients had little or no change in eosinophil levels; 4 patients had large increases, but no specific trend toward improvement in lung function was observed in these patients Fig. S11 and Table S6 in the Supplementary Appendix. Results for the 15 patients for whom data on sputum eosinophil anticytokine Therapie für Psoriasis were available are shown in Table S7 in the Supplementary Appendix.
The events were generally nonspecific and of mild-to-moderate intensity. Four patients had a serious adverse event: There were no deaths. Three adverse events in the placebo group led to discontinuation of the study drug psoriasis, asthma exacerbation, and an upper respiratory tract infectionas did three adverse events in the dupilumab group anticytokine Therapie für Psoriasis of bipolar disorder, angioedema, and an increase in asthma symptoms. The adverse event reported as angioedema and deemed to be related to the study drug occurred in a year-old woman after receipt anticytokine Therapie für Psoriasis the ninth dose of the study Laser für die Behandlung von Psoriasis. It was manifested as a progressive papular rash, urticaria, and edema at, and distant to, the injection site; it persisted for 1 week and resolved after nonurgent symptomatic treatment prednisone and diphenhydramine and early discontinuation of the study drug.
This adverse event was preceded by milder rashes at the injection site after receipt of the first and sixth doses of the study drug. Among the most common adverse events occurring in at least three patients in either study group Table 3injection-site reactions, nasopharyngitis, nausea, and headache occurred more frequently with dupilumab than with placebo. No clinically significant changes in vital signs or findings on physical examination, clinical laboratory testing, or ECG were reported in either group.
Previous studies have suggested that the Th2 cytokines interleukin-4 and interleukin have a role in asthma. Our data and those from prior studies suggest that blocking both cytokines may be more effective than targeting either alone. Melma Juckreiz gefährlich CHEN, dupilumab showed substantial efficacy with regard to both objective and patient-reported end points even when added to inhaled glucocorticoids and LABAs, with efficacy maintained despite the discontinuation of background therapy.
FEV 1 improved by more than ml when dupilumab, as compared Psoriasis Abstrich Jod placebo, was added to inhaled glucocorticoids and LABAs, an increase sustained during their tapering and discontinuation. Rapid, sustained improvements over the duration of the study were also observed in symptoms, beta-agonist use, and ACQ5 score.
For the ACQ5 score, the between-group difference in the change from baseline anticytokine Therapie für Psoriasis 0. Levels anticytokine Therapie für Psoriasis the biomarkers Fe NOserum Anticytokine Therapie für Psoriasis, eotaxin-3, and TARC decreased with dupilumab, confirming the biologic activity of the drug. There was no clear pattern of change in blood eosinophil levels with dupilumab.
Future studies of dupilumab should include observations of eosinophil levels. The magnitude and breadth of efficacy that we observed exceed those in other studies of Th2 cytokine inhibtion. In addition, three studies evaluating monoclonal antibodies to the Th2 cytokine interleukin-5 in patients with eosinophilia showed reductions in asthma exacerbations and eosinophil levels, with little effect on lung function or symptoms.
Injection-site reactions, nasopharyngitis, nausea, and headache occurred more frequently with dupilumab than with placebo, and a progressive papular rash, urticaria, and edema developed in 1 patient, leading to nonurgent symptomatic treatment and early anticytokine Therapie für Psoriasis of dupilumab. Because only 52 patients received dupilumab in our study, the spectrum of potential adverse events is unknown; patients will continue to be monitored closely for such events.
In anticytokine Therapie für Psoriasis, our week study showed that in a subpopulation of patients with persistent asthma, dupilumab therapy, as kann das Haar aus with placebo, was associated with fewer exacerbations induced by medication withdrawal; the benefit was primarily identified by changes in peak flow and http://outdoor-frauen.de/tragen-fettverbrauch-bei-psoriasis.php use.
The short study period and the definition used for exacerbation may not reflect real-world asthma exacerbations. Further studies are needed to confirm these observations and better define the target population, dosing regimen, and long-term efficacy and safety. Wenzel reports receiving grant support through her institution and travel support from Sanofi; grant support and consulting fees through her institution from Amgen; grant support and consulting fees through her institution from Merck; continue reading support through her institution from Array BioPharma, Genentech, and GlaxoSmithKline; and consulting fees from Regeneron Pharmaceuticals and, through her institution, from Actelion, Gilead, and Teva.
Pearlman reports receiving grant support through his institution from GlaxoSmithKline, Meda, Merck, Novartis, Sanofi, Sunovion, and Teva. Sher reports receiving grant support from Sanofi. Skobieranda, Wang, Kirkesseli, Bock, Ming, and Anticytokine Therapie für Psoriasis report being full-time employees and shareholders of Anticytokine Therapie für Psoriasis. Rocklin reports having been a full-time employee of Sanofi during the conduct of the anticytokine Therapie für Psoriasis and now being an employee of Covance.
Hamilton, Radin, Stahl, Yancopoulos, and Graham report being full-time employees and shareholders of Regeneron Pharmaceuticals. No other potential conflict of interest relevant to this article was reported. Disclosure forms provided by the authors are available with the full text of this article at NEJM.
We thank the study patients for their participation; the members of the independent data monitoring committee James P. PCS Global Publications, Sanofiand E. Jay Bienen for their assistance with the preparation of the manuscript. From the Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh S. Address reprint requests to Dr. Wenzel at Fifth Ave. MMWR Morb Mortal Wkly Rep ; Bateman EDBoushey HABousquet Jet al.
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Millien, Psoriasis Medikamentenpreise Qian, Li-Zhen Song, Vincent Frazier, Choel Kim, Jeong Joo Kim, Richard A. Milner, Yuan Zhang, Pijus Anticytokine Therapie für Psoriasis. Mandal, Amber Luong, Farrah Kheradmand, John S.
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The Lancet Respiratory Medicine 3: Graham, Gianluca Pirozzi, Neil Stahl, George D. Nature Reviews Drug Discovery Jennifer D Hamilton, Benjamin Ungar, Emma Guttman-Yassky. Chang Xiao, Jocelyn M.
Biagini Myers, Hong Ji, Kelly Metz, Lisa J. Martin, Mark Lindsey, Hua He, Racheal Powers, Ashley Ulm, Brandy Ruff, Mark B. Somineni, Jeffrey Simmons, Richard T. Denise Halpern Silveira, Linjie Zhang, Silvio OM Prietsch, Amilcare Angelo Anticytokine Therapie für Psoriasis, Lulie Rosane Odeh Susin. Journal of Paediatrics and Anticytokine Therapie für Psoriasis Health Reitsma, Huib Storm, Elisabeth H. Bel, Anneke ten Brinke. Marc Gauthier, Anuradha Ray, Sally E.
Holgate, Sally Wenzel, Dirkje S. Weiss, Harald Renz, Peter D. Nature Reviews Disease Primers Naina Gour, Marsha Wills-Karp. Phillip E Korenblat, H James Wedner. Kohei Hasegawa, Samantha J. Stoll, Jason Ahn, Jane C. Eric D Bateman, Helen K Reddel, Richard N van Zyl-Smit, Alvar Agusti.
Potential benefits of calcitriol. Accuracy of cutoffs in blood eosinophil measurements versus a composite index, ELEN. Nicola A Hanania, Michael Noonan, Jonathan Corren, Phillip Korenblat, Yanan Zheng, Saloumeh K Fischer, Melissa Cheu, Wendy S Putnam, Elaine Murray, Heleen Scheerens, Cecile TJ Anticytokine Therapie für Psoriasis, Romeo Maciuca, Sarah Gray, Ramona Doyle, Dana McClintock, Julie Olsson, John G Matthews, Karl Yen.
Colin Powell, Stephen J Milan, Kerry Dwan, Lynne Bax, Nicola Walters, Colin Powell. Mepolizumab versus placebo for asthma. Cochrane Database of Systematic Reviews. Haribalakrishna Balasubramanian, Anitha Ananthan, Shripada Rao, Sanjay Patole. Melanie Eschborn, Benno Weigmann, Sonja Reissig, Ari Waisman, Joachim Saloga, Iris Bellinghausen.
Vera Gielen, Annemarie Sykes, Jie Zhu, Brian Chan, Jonathan Macintyre, Nicolas Regamey, Elisabeth Kieninger, Atul Gupta, Anticytokine Therapie für Psoriasis Shoemark, Cara Bossley, Jane Davies, Sejal Saglani, Patrick Walker, Sandra E. Dalpke, Onn-Min Kon, Andrew Bush, Sebastian L. L Karra, O Haworth, R Priluck, B D Levy, F Levi-Schaffer. Revue des Maladies Respiratoires Lisa Giovannini-Chami, Marc Albertini, Pierre Scheinmann, Jacques de Blic.
Paediatric Respiratory Reviews Krug, Norbert, Hohlfeld, Jens M. International Reviews of Immunology Andrea Coverstone, Leonard B. Evaluation and Phenotypic Advances.
Mitesh Patel, Dominick Shaw. Chronic Respiratory Disease Current Medical Research and Opinion Andrew Bush, Sabine Kleinert, Ian D Pavord. Journal of Clinical Medicine 4: Burrows, Celine Dumont, Clare L.
European Journal of Immunology Hui Fang Lim, Parameswaran Nair. Anticytokine Therapie für Psoriasis Review of Respiratory Medicine 9: Bauke Pauwels, Karin Jonstam, Anticytokine Therapie für Psoriasis Bachert. Fanny Legrand, Amy D. Current Status and Future Prospects. Jared Darveaux, William W.
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Michelle Fox Huffaker, Wanda Phipatanakul. A H Wagener, S B de Nijs, R Lutter, A R Sousa, E J M Weersink, E H Bel, P J Sterk. The next steps toward personalized care. Bauer, Monali Manohar, Anne Marie Singh, David C. Applications for food allergy. Shinji Noda, James G. Binita Kane, Stephen J Fowler, Rob Niven. Trejo Bittar, Samuel A. Annual Review of Pathology: Mechanisms of Disease Susanne Radonjic-Hoesli, Peter Valent, Amy D.
Annual Review of Pharmacology anticytokine Therapie für Psoriasis Toxicology Kristina Sophie Ibler, Gregor BE Jemec. Expert Opinion on Therapeutic Targets anticytokine Therapie für Psoriasis Giovanni B Pajno, Anticytokine Therapie für Psoriasis C Nadeau, Giovanni Passalacqua, Lucia Caminiti, Ben Hobson, David C Jay, Stefania Arasi, Fernanda Chiera, Giuseppina Salzano.
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Valentine Ongeri Millien, Wen Lu, Garbo Mak, Xiaoyi Yuan, J. Morgan Knight, Paul Porter, Farrah Kheradmand, David B. Annals of the American Thoracic Society Byers, Jennifer-Alexander Brett, Anand C. Patel, Eugene Agapov, Xiaohua Jin, Kangyun Wu.
The Role of IL—Expressing Epithelial Progenitor Cells. Guy Brusselle, Ken Bracke. Sung-Hyun Park, Wen-Chi Chen, Nafiseh Esmaeil, Benjamin Lucas, Leigh M. Marsh, Joan Reibman, Gabriele Grunig. Krueger, Neil Graham, George D. Yancopoulos, Anticytokine Therapie für Psoriasis Pirozzi, Emma Guttman-Yassky.
Bonvini, Chantal Donovan, Rachel E. Foong, Bing Han, Aruni Jha, Yasin Shaifta, Marieke Smit, Jill R. Laura J Simpson, Sana Patel, Nirav R Bhakta, David F Choy, Hans D Brightbill, Xin Ren, Yanli Wang, Heather H Pua, Dirk Baumjohann, Misty M Montoya, Marisella Panduro, Kelly A Remedios, Xiaozhu Huang, John V Fahy, Joseph R Arron, Prescott G Woodruff, K Mark Ansel.
Zeiger, Michael Schatz, Qiaowu Li, Wansu Chen, Deepak B. Khatry, David Gossage, Trung N. The American Journal of Medicine anticytokine Therapie für Psoriasis Mimicking human allergy through mouse models. Huan Zhang, Mika Gustafsson, Colm Nestor, Kian Fan Chung, Mikael Benson. The Lancet Respiratory Medicine 2: Mazen Al-Alawi, Tidi Hassan, Sanjay H. Science Translational Medicine 6: Byers, Jennifer Alexander-Brett, Xinyu Wang.
Tamotsu Ishizuka, Takeshi Hisada, Motoaki Hatori, Akio Koike, Kikuo Hanabuchi, Shinichi Matsuzaki, Yosuke Kamide, Mitsuyoshi Utsugi, Haruka Aoki, Reiko Check this out, Noriko Yanagitani, Yasuhiko Koga, Akihiro Ono, Kyoichi Kaira, Noriaki Sunaga, Kunio Dobashi, Takahiro Tsuburai, Kazuo Akiyama, Masanobu Yamada, Kazuhiro Suzuki, Masatomo Mori.
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Noel J C Snell. Alex Poole, Anticytokine Therapie für Psoriasis Urbanek, Celeste Eng, Jeoffrey Schageman, Sean Jacobson, Brian Anticytokine Therapie für Psoriasis. Roth, Anticytokine Therapie für Psoriasis Kumar, Sharon Lutz, Andrew H.
Burchard, Jose Rodriguez-Santana, Max A. Donata Vercelli, Justyna Gozdz, Erika von Mutius. Karla Enriquez, Eduardo Lehrer, Joaquim Mullol. Bice, Evelyn Leechawengwongs, Anthony Montanaro.
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Omalizumab for asthma in adults and children. Manali Mukherjee, Roma Sehmi, Parameswaran Nair. World Allergy Organization Journal 7: Tuberculosis and Respiratory Diseases anticytokine Therapie für Psoriasis A Novel Biomarker for Asthma Management. Nathan Hambly, Parameswaran Nair. Konstantinos Pappas, Andriana I.
Papaioannou, Konstantinos Kostikas, Nikolaos Tzanakis. Chronic obstructive pulmonary disease and asthma. Massimo Caruso, Emanuele Crisafulli, Raffaella Lizzio, Riccardo Polosa. The importance of dysregulated barrier immunity. Angira Dasgupta, Helen Neighbour, Parameswaran Nair. Bjoern Buehring, Ravi Viswanathan, Neil Binkley, William Busse. An update on effects and management. Kaharu Sumino, Mario Castro.
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Primary Care Respiratory Journal Markus J Ege, Erika von Mutius. WechslerMichael E. Luca Gallelli, Maria Teresa Busceti, Alessandro Vatrella, Rosario Maselli, Girolamo Pelaia. BioMed Research International See anticytokine Therapie für Psoriasis Challenge and other articles in the series. Inhibiting Interleukin-4 and Interleukin in Difficult-to-Control Asthma. The New England Journal of Medicine. The narration and closed captions in this video are in English.
Adobe Flash Player is required to view this feature. If you are using an operating anticytokine Therapie für Psoriasis that does not support Flash, we are working to bring you alternative formats. Background Moderate-to-severe asthma remains poorly treated. Results A total of 52 patients were assigned anticytokine Therapie für Psoriasis the dupilumab group, and 52 patients were assigned to the placebo group. Conclusions In patients with persistent, moderate-to-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations when LABAs and inhaled glucocorticoids were withdrawn, with improved lung function and reduced anticytokine Therapie für Psoriasis of Th2-associated inflammatory markers.
Media in This Article Figure 1 Study Design and Numbers of Patients Enrolled and Included in the Analysis. Figure 2 Primary and Key Secondary Efficacy End Points Intention-to-Treat Population.
Article Activity articles have cited this article. Methods Study Design and Oversight This randomized, double-blind, placebo-controlled, parallel-group phase 2A study was conducted at 28 sites in the Anticytokine Therapie für Psoriasis States from March through October Study Click the following article Patients were anticytokine Therapie für Psoriasis assigned in a anticytokine Therapie für Psoriasis Outcomes The primary efficacy end point was the occurrence of an asthma exacerbation, as previously defined, during the week intervention period.
Statistical Analysis Efficacy analyses were performed in the intention-to-treat population, defined as all randomly assigned patients who received at least one dose of the study drug. Results Patients A total of patients from screened underwent randomization, with 52 assigned to each study group Figure 1B.
Primary End Point Asthma exacerbations occurred in 26 patients: Secondary End Points The time to an asthma exacerbation was longer Figure 2B and the risk of exacerbation was reduced with dupilumab as compared with placebo hazard ratio, 0. Lung Function over Time Dupilumab was associated with a significant increase from baseline in percent of predicted FEV 1 and actual FEV 1 at week 2, which was maintained through week 12 Figure 2Cand Table S3 in the Supplementary Appendix despite discontinuation of LABAs and inhaled glucocorticoids, with a small decrease in FEV 1 at week 5 coinciding with discontinuation of LABAs.
Asthma Symptoms and Beta-Agonist Use over Time The ACQ5 score was improved in both study groups at week 1 Fig. Pharmacodynamic and Th2-Associated Biomarkers With placebo, Fe NO values remained stable through week 8, followed by an increase at week 12 that coincided with discontinuation of inhaled glucocorticoids Figure 3A Figure 3 Values for Key Pharmacodynamic Markers over the Duration of the Study Intention-to-Treat Population. Discussion Previous studies have suggested that the Th2 cytokines interleukin-4 and interleukin have a role in asthma.
Supported by Sanofi and Regeneron Pharmaceuticals. This article was published on May 21,at NEJM. Source Information From the Division anticytokine Therapie für Psoriasis Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh S.
References 1 Vital signs:
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Original Article. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D.
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Original Article. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D.
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Original Article. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D.
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Original Article. Lebrikizumab Treatment in Adults with Asthma. Jonathan Corren, M.D., Robert F. Lemanske, Jr., M.D., Nicola A. Hanania, M.D., Phillip E. Korenblat, M.
- Psoriasis Gewürznelken
Original Article. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. Sally Wenzel, M.D., Linda Ford, M.D., David Pearlman, M.D., Sheldon Spector, M.D.