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Ruxolitinib

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https://www.readbyqxmd.com/read/27916398/ruxolitinib-for-the-treatment-of-inadequately-controlled-polycythaemia-vera-without-splenomegaly-response-2-a-randomised-open-label-phase-3b-study
#1
Francesco Passamonti, Martin Griesshammer, Francesca Palandri, Miklos Egyed, Giulia Benevolo, Timothy Devos, Jeannie Callum, Alessandro M Vannucchi, Serdar Sivgin, Caroline Bensasson, Mahmudul Khan, Nadjat Mounedji, Guray Saydam
BACKGROUND: In the pivotal RESPONSE study, ruxolitinib, a Janus kinase (JAK)1 and JAK2 inhibitor, was superior to best available therapy at controlling haematocrit and improving splenomegaly and symptoms in patients with polycythaemia vera with splenomegaly who were inadequately controlled with hydroxyurea. In this study, we assessed the efficacy and safety of ruxolitinib in controlling disease in patients with polycythaemia vera without splenomegaly who need second-line therapy. METHODS: RESPONSE-2 is a randomised, open-label, phase 3b study assessing ruxolitinib versus best available therapy in patients with polycythaemia vera done in 48 hospitals or clinics across 12 countries in Asia, Australia, Europe, and North America...
December 1, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27892610/beside-to-bench-jak-inhibitor-ruxolitinib-inhibits-the-expression-of-cytokines-characteristic-of-cutaneous-lupus-erythematosus
#2
Anna Sophie Klaeschen, Dominik Wolf, Peter Brossart, Thomas Bieber, Joerg Wenzel
This study was stimulated by the clinical observation of a rapid response of a chilblain lupus patient to treatment with JAK1/2-kinase inhibitor ruxolitinib. We investigated the in-vivo expression of phospho-JAK2 in CLE skin samples as well as the immunomodulatory in-vitro effect of ruxolitinib in cultured immortalized keratinocytes and in a 3D human epidermis model (epiCS). Our results demonstrate that ruxolitinib significantly decreases the production of CLE-typical cytokines (CXCL10, CXCL9, MxA) and might be a promising drug for future clinical studies in patients with CLE and related autoimmune skin diseases...
November 28, 2016: Experimental Dermatology
https://www.readbyqxmd.com/read/27889820/ruxolitinib-in-clinical-practice-for-primary-and-secondary-myelofibrosis-an-analysis-of-safety-and-efficacy-of-gruppo-laziale-of-ph-negative-mpn
#3
Massimo Breccia, Alessandro Andriani, Marco Montanaro, Elisabetta Abruzzese, Francesco Buccisano, Michele Cedrone, Antonietta Centra, Nicoletta Villivà, Francesca Celesti, Malgorzata Monica Trawinska, Fulvio Massaro, Ambra Di Veroli, Barbara Anaclerico, Gioia Colafigli, Matteo Molica, Antonio Spadea, Luca Petriccione, Giuseppe Cimino, Roberto Latagliata
Ruxolitinib, a JAK1 and JAK2 inhibitor, has been tested and approved for the treatment of primary and secondary myelofibrosis (MF). Aim of our study is to report safety and efficacy of ruxolitinib in 98 patients affected by MF treated outside clinical trials and collected and treated consecutively by the Lazio Cooperative Group for Ph negative myeloproliferative diseases.There were 45 males and 53 females; median age was 61.8 years (range 35.3-88). Forty-five patients were diagnosed as primary MF and 53 as secondary MF...
November 26, 2016: Annals of Hematology
https://www.readbyqxmd.com/read/27887955/treatment-of-hypereosinophilic-syndrome-with-cutaneous-involvement-with-the-jak-inhibitors-tofacitinib-and-ruxolitinib
#4
Brett King, Alfred Ian Lee, Jaehyuk Choi
No abstract text is available yet for this article.
November 22, 2016: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/27884974/from-leeches-to-personalized-medicine-evolving-concepts-in-the-management-of-polycythemia-vera
#5
Alessandro Maria Vannucchi
Polycythemia vera (PV), a clonal disorders of hematopoietic stem/progenitor cells that manifests with prevalent expansion of red cell mass, is the most frequent among chronic myeloproliferative neoplasms (MPN). It is characterized by a V617F point mutation in JAK2 exon 14 , or less common mutations in exon 12, in virtually all cases. The landmark discovery of autonomously activated JAK/STAT signaling pathway paved the way for the clinical development of the first target drug, the JAK1 and JAK2 inhibitor ruxolitinib, that is now approved for patients with resistance or intolerance to hydroxyurea...
November 24, 2016: Haematologica
https://www.readbyqxmd.com/read/27882812/should-we-be-treating-lower-risk-myelofibrosis-patients-with-a-jak2-inhibitor
#6
Guido Lancman, John Mascarenhas
Myelofibrosis (MF) is a Philadelphia chromosome-negative myeloproliferative neoplasm that is associated with debilitating constitutional symptoms, progressive splenomegaly, and cytopenias. Ruxolitinib, a JAK1/2 inhibitor, is currently the only drug approved for the treatment of patients with intermediate or high risk MF. There is rationale and even limited clinical data supporting the use of ruxolitinib in lower risk patients, although this has not yet been validated in a randomized controlled trial. Areas covered: We examine rationale for using ruxolitinib in lower risk MF patients, including survival data from COMFORT-I and COMFORT-II, specific patient populations that may derive clinical benefit, and the future impact of molecular analysis on risk stratification and treatment...
December 5, 2016: Expert Review of Hematology
https://www.readbyqxmd.com/read/27880982/safety-and-efficacy-of-ruxolitinib-in-splanchnic-vein-thrombosis-associated-with-myeloproliferative-neoplasms
#7
Lisa Pieri, Chiara Paoli, Umberto Arena, Fabio Marra, Fabio Mori, Mery Zucchini, Stefano Colagrande, Alessandro Castellani, Arianna Masciulli, Vittorio Rosti, Valerio De Stefano, Silvia Betti, Guido Finazzi, Maria Luisa Ferrari, Elisa Rumi, Marco Ruggeri, Ilaria Nichele, Paola Guglielmelli, Rajmonda Fjerza, Carmela Mannarelli, Tiziana Fanelli, Lucia Merli, Giuditta Corbizi Fattori, Margherita Massa, Giuseppe Cimino, Alessandro Rambaldi, Giovanni Barosi, Mario Cazzola, Tiziano Barbui, Alessandro M Vannucchi
Splanchnic vein thrombosis (SVT) is one of the vascular complications of myeloproliferative neoplasms (MPN). We designed a phase 2 clinical trial to evaluate safety and efficacy of ruxolitinib in reducing splenomegaly and improving disease-related symptoms in patients with MPN-associated SVT. Patients, diagnosed with myelofibrosis in 12 cases, polycythemia vera in 5 and essential thrombocythemia in 4, received ruxolitinib for 24 weeks in the core study period. Spleen volume was assessed by magnetic resonance imaging (MRI) and splanchnic vein circulation by echo-Doppler analysis...
November 23, 2016: American Journal of Hematology
https://www.readbyqxmd.com/read/27873163/an-update-on-the-use-of-immunomodulators-in-primary-immunodeficiencies
#8
REVIEW
Pandiarajan Vignesh, Amit Rawat, Surjit Singh
The genomic revolution in the past decade fuelled by breathtaking advances in sequencing technologies has defined several new genetic diseases of the immune system. Many of these newly characterized diseases are a result of defects in genes involved in immune regulation. The discovery of these diseases has opened a vista of new therapeutic possibilities. Immunomodulatory agents, a hitherto unexplored therapeutic option in primary immunodeficiency diseases have been tried in a host of these newly described maladies...
November 21, 2016: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/27860260/integration-of-ruxolitinib-into-dose-intensified-therapy-targeted-against-a-novel-jak2-f694l-mutation-in-b-precursor-acute-lymphoblastic-leukemia
#9
Jodi R Mayfield, David R Czuchlewski, James M Gale, Ksenia Matlawska-Wasowska, Mohammad A Vasef, Christian Nickl, Gavin Pickett, Scott A Ness, Stuart S Winter
A 17-year-old girl with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) with persistent minimal residual disease (MRD) who underwent standard chemotherapy was found to have a BCR-ABL1-like gene expression pattern. Genome sequencing revealed a JAK2 mutation not previously described in BCP-ALL and a potential therapeutic target. Due to concern for an on-therapy relapse, the JAK2 inhibitor ruxolitinib was incorporated into a modified chemotherapy backbone to achieve complete remission prior to stem cell transplant...
November 15, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27858987/the-efficacy-and-safety-of-continued-hydroxycarbamide-therapy-versus-switching-to-ruxolitinib-in-patients-with-polycythaemia-vera-a-randomized-double-blind-double-dummy-symptom-study-relief
#10
Ruben Mesa, Alessandro M Vannucchi, Abdulraheem Yacoub, Pierre Zachee, Mamta Garg, Roger Lyons, Steffen Koschmieder, Ciro Rinaldi, Jennifer Byrne, Yasmin Hasan, Francesco Passamonti, Srdan Verstovsek, Deborah Hunter, Mark M Jones, Huiling Zhen, Dany Habr, Bruno Martino
The randomized, double-blind, double-dummy, phase 3b RELIEF trial evaluated polycythaemia vera (PV)-related symptoms in patients who were well controlled with a stable dose of hydroxycarbamide (also termed hydroxyurea) but reported PV-related symptoms. Patients were randomized 1:1 to ruxolitinib 10 mg BID (n = 54) or hydroxycarbamide (prerandomization dose/schedule; n = 56); crossover to ruxolitinib was permitted after Week 16. The primary endpoint, ≥50% improvement from baseline in myeloproliferative neoplasm -symptom assessment form total symptom score cytokine symptom cluster (TSS-C; sum of tiredness, itching, muscle aches, night sweats, and sweats while awake) at Week 16, was achieved by 43·4% vs...
November 8, 2016: British Journal of Haematology
https://www.readbyqxmd.com/read/27858230/efficacy-and-safety-of-jak-inhibitor-inc424-in-patients-with-primary-and-post-polycythemia-vera-or-post-essential-thrombocythemia-myelofibrosis-in-the-chinese-population
#11
Xin Du, Daobin Zhou
A phase II study (A2202) was performed to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in 63 Chinese MF patients. Ruxolitinib was given twice a day (bid) at a starting dose of 15 mg (n = 25) or 20 mg (n = 38) based on a baseline platelet count. About 94.7% of the patients achieved a reduction in spleen size, 27.0% of which exhibited significant reduction (≥ 35%) at week 24. Significant improvement in debilitating constitutional symptoms, as assessed by MFSAF v2.0, was observed in patients treated with ruxolitinib...
November 17, 2016: Frontiers of Medicine
https://www.readbyqxmd.com/read/27843657/reactivation-of-pulmonary-tuberculosis-following-treatment-of-myelofibrosis-with-ruxolitinib
#12
Maheen Z Abidi, Javeria Haque, Parvathi Varma, Horatiu Olteanu, Guru Subramanian Guru Murthy, Binod Dhakal, Parameswaran Hari
Ruxolitinib is widely in use for treatment of myeloproliferative disorders. It causes inhibition of the Janus kinase (JAK) signal transducer and activation of transcription (STAT) pathway, which plays a key role in the underlying pathophysiology of myeloproliferative diseases. We describe a case of reactivation pulmonary tuberculosis in a retired physician while on treatment with ruxolitinib. We also review the literature on opportunistic infections following use of ruxolitinib. Our case highlights the importance of screening for latent tuberculosis in patients from highly endemic areas prior to start of therapy with ruxolitinib...
2016: Case Reports in Hematology
https://www.readbyqxmd.com/read/27832516/assessing-the-safety-and-efficacy-of-ruxolitinib-in-a-multicenter-open-label-study-in-japanese-patients-with-myelofibrosis
#13
Norio Komatsu, Keita Kirito, Kazuya Shimoda, Takayuki Ishikawa, Kohshi Ohishi, Kazuma Ohyashiki, Naoto Takahashi, Hikaru Okada, Taro Amagasaki, Toshio Yonezu, Koichi Akashi
Ruxolitinib is a potent JAK1/JAK2 inhibitor that has demonstrated durable improvements in splenomegaly, symptoms, and overall survival in controlled clinical trials in patients with myelofibrosis. The single-arm study reported here was initiated to collect further safety and efficacy data in Japanese patients with myelofibrosis and is the largest study of ruxolitinib in this population. The primary objective was to assess safety. Secondary endpoints included changes in spleen size and patient-reported outcomes...
November 10, 2016: International Journal of Hematology
https://www.readbyqxmd.com/read/27819036/evaluation-of-short-term-ruxolitinib-tapering-strategy-before-allogeneic-stem-cell-transplantation-for-primary-myelofibrosis-through-the-transition-of-serum-cytokines-and-growth-factors
#14
Souichi Shiratori, Takahiro Tateno, Shinichi Ito, Yutaka Tsutsumi, Takanori Teshima
No abstract text is available yet for this article.
August 2016: Transplantation Direct
https://www.readbyqxmd.com/read/27808416/remission-of-myasthenia-gravis-with-musk-antibodies-during-ruxolitinib-treatment
#15
Paolo E Alboini, Amelia Evoli, Valentina Damato, Raffaele Iorio, Emanuela Bartoccioni
No abstract text is available yet for this article.
November 3, 2016: Muscle & Nerve
https://www.readbyqxmd.com/read/27807369/calreticulin-mutant-mice-develop-essential-thrombocythemia-that-is-ameliorated-by-the-jak-inhibitor-ruxolitinib
#16
K Shide, T Kameda, T Yamaji, M Sekine, N Inada, A Kamiunten, K Akizuki, K Nakamura, T Hidaka, Y Kubuki, H Shimoda, A Kitanaka, A Honda, A Sawaguchi, H Abe, T Miike, H Iwakiri, Y Tahara, M Sueta, S Hasuike, S Yamamoto, K Nagata, K Shimoda
Mutations of calreticulin (CALR) are detected in 25-30% of patients with essential thrombocythemia (ET) or primary myelofibrosis and cause frameshifts that result in proteins with a novel C-terminal. We demonstrate that CALR mutations activated signal transducer and activator of transcription 5 (STAT5) in 293T cells in the presence of thrombopoietin receptor (MPL). Human megakaryocytic CMK11-5 cells and erythroleukemic F-36P-MPL cells with knocked-in CALR mutations showed increased growth and acquisition of cytokine-independent growth, respectively, accompanied by STAT5 phosphorylation...
November 29, 2016: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27801315/-efficacy-and-safety-of-jak-inhibitor-ruxolitinib-in-chinese-patients-with-myelofibrosis-results-of-a-1-year-follow-up-of-a2202
#17
J Jin, X Du, D B Zhou, J M Li, J Y Li, M Hou, T Liu, D P Wu, Y Hu, Z J Xiao
Objective: To evaluate the efficacy and safety of ruxolitinib in Chinese myelofibrosis patients. Methods: This study enrolled 63 Chinese patients(32 males and 31 females)in total, whose median age was 55(25-79)years. The initial dose of ruxolitinib was 30mg/d(25 patients)with a baseline of PLT(100-200)×10(9)/L and 40 mg/d(38 patients)with a baseline of PLT>200×10(9)/L. Spleen volume, quality of life(QOL)and symptoms were evaluated by MRI/CT, European Organization for Research and Treatment of Cancer QOL Questionnaire Core 30(EORTC QLQ-C30)and MF Symptom Assessment Form(MFSAF)v2...
October 14, 2016: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/27796499/underlying-mechanisms-of-the-jak2v617f-mutation-in-the-pathogenesis-of-myeloproliferative-neoplasms
#18
A Mullally
Chronic myeloproliferative neoplasms (MPN) comprise a spectrum of clonal neoplastic disorders characterized by overproduction of terminally differentiated cells of the myeloid lineage. A common genetic basis for the BCR-ABL-negative MPN disorders was elucidated in 2005 with the identification of the JAK2V617F mutation in the majority of MPN patients. The discovery of JAK2V617F had a dramatic impact on the diagnosis and treatment of MPN. Testing for JAK2 mutations is now included in the World Health Organization (WHO) criteria for the diagnosis of MPN, and in 2011 the oral JAK2 kinase inhibitor ruxolitinib became the first Food and Drug Administration (FDA)-approved drug for the treatment of myelofibrosis...
November 2016: Der Pathologe
https://www.readbyqxmd.com/read/27796129/-diagnosis-and-treatment-of-polycythaemia-vera-state-of-the-art
#19
Imelda Marton, Zsófia Simon, Zita Borbényi
Polycythaemia vera (PV), a condition characterized by blood hyperviscosity due to the expansion of the erythrocyte mass is the most common entity among all Philadelphia chromosome-negative myeloproliferative neoplasms. Arterial and venous thrombotic events are leading determinants of morbidity and mortality but impairment of quality of life due to vasomotor symptoms (erythromelalgia, pruritus) and disease-associated symptoms (tiredness, fatigue, pruritus, night sweats, vision problems, headache, concentration loss, abdominal discomfort, early satiety, fever, weight loss) are also present...
October 2016: Orvosi Hetilap
https://www.readbyqxmd.com/read/27793879/cml-cells-actively-evade-host-immune-surveillance-through-cytokine-mediated-downregulation-of-mhc-ii-expression
#20
Anuradha Tarafdar, Lisa E M Hopcroft, Paolo Gallipoli, Francesca Pellicano, Jennifer Cassels, Alan Hair, Koorosh Korfi, Heather G Jørgensen, David Vetrie, Tessa L Holyoake, Alison M Michie
Targeting the fusion oncoprotein BCR-ABL with tyrosine kinase inhibitors has significantly impacted on chronic myeloid leukemia (CML) treatment, transforming the life expectancy of patients; however the risk of relapse remains, due to persistence of leukemic stem cells (LSCs). Therefore it is imperative to explore the mechanisms that result in LSC survival and develop new therapeutic approaches. We now show that MHC-II and its master regulator class II transactivator (CIITA) are downregulated in CML compared to non-CML stem/progenitor cells in a BCR-ABL kinase independent manner...
October 28, 2016: Blood
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