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1. Recent advances in understanding spleen tyrosine kinase (SYK) in human biology and disease, with a focus on fostamatinib

Author

Nichola Cooper, Waleed Ghanima, Quentin A Hill, Phillip LR Nicolson, Vadim Markovtsov, and Craig Kessler

Subjects
cevidoplenib, entospletinib, fostamatinib, hmpl-523, spleen tyrosine kinase, syk, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Spleen tyrosine kinase (SYK) is an important regulatory molecule of signal transduction pathways involved in the pathogenesis of autoimmune diseases such as immune thrombocytopenia (ITP), and the SYK-signaling pathway has emerged as a potential target for the treatment of numerous diseases. The aim of this narrative review is to summarize the biological properties of SYK and its involvement in disease pathways, provide an update on SYK inhibitors in the treatment of ITP, and consider other potential applications. Fostamatinib, the only licensed SYK inhibitor to date, produces clinical response in ITP patients, including those who are refractory to other treatments. It appears to reduce the risk of thrombotic events and may therefore be a drug to consider for patients with an increased thrombotic risk. Encouraging results have also been obtained in the treatment of warm autoimmune hemolytic anemia. Several other SYK inhibitors have entered clinical trials for a range of indications, reflecting the ability of these drugs to affect multiple signaling pathways. SYK inhibitors have the potential to target several aspects of COVID-19 pathogenesis including thrombosis, without affecting normal hemostasis, and data from the first study of fostamatinib in COVID-19 are encouraging. It is hoped that ongoing trials in autoimmune indications other than ITP, as well as in hematological malignancies and other disorders, confirm the promise of SYK inhibitors.

Published
2023
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2. International recommendations on the diagnosis and treatment of acquired hemophilia A

Author

Andreas Tiede, Peter Collins, Paul Knoebl, Jerome Teitel, Craig Kessler, Midori Shima, Giovanni Di Minno, Roseline d’Oiron, Peter Salaj, Victor Jiménez-Yuste, Angela Huth-Kühne, and Paul Giangrande

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Acquired hemophilia A (AHA), a rare bleeding disorder caused by neutralizing autoantibodies against coagulation factor VIII (FVIII), occurs in both men and women without a previous history of bleeding. Patients typically present with an isolated prolonged activated partial thromboplastin time due to FVIII deficiency. Neutralizing antibodies (inhibitors) are detected using the Nijmegen-modified Bethesda assay. Approximately 10% of patients do not present with bleeding and, therefore, a prolonged activated partial thromboplastin time should never be ignored prior to invasive procedures. Control of acute bleeding and prevention of injuries that may provoke bleeding are top priorities in patients with AHA. We recommend treatment with bypassing agents, including recombinant activated factor VII, activated prothrombin complex concentrate, or recombinant porcine FVIII in bleeding patients. Autoantibody eradication can be achieved with immunosuppressive therapy, including corticosteroids, cyclophosphamide and rituximab, or combinations thereof. The median time to remission is 5 weeks, with considerable interindividual variation. FVIII activity at presentation, inhibitor titer and autoantibody isotype are prognostic markers for remission and survival. Comparative clinical studies to support treatment recommendations for AHA do not exist; therefore, we provide practical consensus guidance based on recent registry findings and the authors’ clinical experience in treating patients with AHA.

Published
2020
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3. Recent advances in understanding spleen tyrosine kinase (SYK) in human biology and disease, with a focus on fostamatinib

Author

Nichola Cooper, Waleed Ghanima, Quentin A Hill, Phillip LR Nicolson, Vadim Markovtsov, and Craig Kessler

Subjects
Purpura, Thrombocytopenic, Idiopathic, Pyridines, Oxazines, Humans, Aminopyridines, COVID-19, Syk Kinase, Hematology, General Medicine, Protein Kinase Inhibitors
Abstract

Spleen tyrosine kinase (SYK) is an important regulatory molecule of signal transduction pathways involved in the pathogenesis of autoimmune diseases such as immune thrombocytopenia (ITP), and the SYK-signaling pathway has emerged as a potential target for the treatment of numerous diseases. The aim of this narrative review is to summarize the biological properties of SYK and its involvement in disease pathways, provide an update on SYK inhibitors in the treatment of ITP, and consider other potential applications. Fostamatinib, the only licensed SYK inhibitor to date, produces clinical response in ITP patients, including those who are refractory to other treatments. It appears to reduce the risk of thrombotic events and may therefore be a drug to consider for patients with an increased thrombotic risk. Encouraging results have also been obtained in the treatment of warm autoimmune hemolytic anemia. Several other SYK inhibitors have entered clinical trials for a range of indications, reflecting the ability of these drugs to affect multiple signaling pathways. SYK inhibitors have the potential to target several aspects of COVID-19 pathogenesis including thrombosis, without affecting normal hemostasis, and data from the first study of fostamatinib in COVID-19 are encouraging. It is hoped that ongoing trials in autoimmune indications other than ITP, as well as in hematological malignancies and other disorders, confirm the promise of SYK inhibitors.Immune thrombocytopenia (ITP) is an autoimmune disease that usually happens when your immune system mistakenly attacks and destroys platelets, which are cells that help blood to clot. Individuals with ITP can experience easy or excessive bruising and bleeding. Scientists have identified that an enzyme called spleen tyrosine kinase (SYK) is involved in numerous biological processes that are associated with the immune system response, inflammation, and some types of cancer in humans. Therefore, it has become a target for new drugs which inhibit the action of SYK. In this review article, the authors provide a summary of the biological properties and actions of SYK and its involvement in various diseases, discuss information about drugs that have been developed as SYK inhibitors for the treatment of ITP, and consider other potential uses for drugs that inhibit SYK. Although several drugs are being developed, the only SYK inhibitor that is currently available for the treatment of ITP is a drug called fostamatinib. In patients with ITP, including those who no longer respond to other treatments, fostamatinib has been shown to improve platelet counts and reduce bleeding events. Researchers are also currently investigating the use of drugs that inhibit SYK, including fostamatinib, for the potential treatment of other diseases associated with inflammation (e.g. rheumatoid arthritis, COVID-19), autoimmunity (e.g. warm autoimmune hemolytic anemia), and blood cancers (e.g. lymphoma, chronic lymphocytic leukemia, and acute myeloid leukemia).

Published
2022

4. Cover Image

Author

Miguel Escobar, Giancarlo Castaman, Santiago Bonanad Boix, Michael Callaghan, Philippe Moerloose, Jonathan Ducore, Cédric Hermans, Janna Journeycake, Cindy Leissinger, James Luck, Johnny Mahlangu, Wolfgang Miesbach, Ismail Haroon Mitha, Claude Négrier, Doris Quon, Michael Recht, Jean François Schved, Amy D. Shapiro, Robert Sidonio, Alok Srivastava, Oleksandra Stasyshyn, Kateryna V. Vilchevska, Michael Wang, Guy Young, W. Allan Alexander, Ahmad Al‐Sabbagh, Daniel Bonzo, Christopher Macie, Thomas A. Wilkinson, and Craig Kessler

Subjects
Hematology, General Medicine, Genetics (clinical)
Published
2021
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5. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep vein thrombosis

Author

Susan R. Kahn, Jim A. Julian, Clive Kearon, Chu-Shu Gu, David J. Cohen, Elizabeth A. Magnuson, Anthony J. Comerota, Samuel Z. Goldhaber, Michael R. Jaff, Mahmood K. Razavi, Andrei L. Kindzelski, Joseph R. Schneider, Paul Kim, Rabih Chaer, Akhilesh K. Sista, Robert B. McLafferty, John A. Kaufman, Brandt C. Wible, Morey Blinder, Suresh Vedantham, Michael Sichlau, Athanasios Vlahos, Steven Smith, Quinn Thalheimer, Nisha Singh, Rekha Harting, John Gocke, Scott Guth, Neel Shah, Paul Brady, Marvin Schatz, Mindy Horrow, Peyman Markazi, Leli Forouzan, Terence A.S. Matalon, David Hertzog, Swapna Goday, Margaret Kennedy, Robert Kaplan, Thomas Campbell, Jamie Hartman, Elmer Nahum, Arvind Venkat, Venkataramu Krishnamurthy, John Rectenwald, Peter Henke, Jonathan Eliason, Jonathon Willatt, Guillermo Escobar, Shaun Samuels, Barry Katzen, James Benenati, Alex Powell, Constantino Pena, Howard Wallach, Ripal Gandhi, Joseph Schneider, Stanley Kim, Farrah Hashemi, Joseph Boyle, Nilesh Patel, Michael Verta, Daniel Leung, Marc Garcia, Phillip Blatt, Jamil Khatri, Dave Epstein, Randall Ryan, Tom Sweeny, Michael Stillabower, George Kimbiris, Tuhina Raman, Paul Sierzenski, Lelia Getto, Michael Dignazio, Mark Horvath, Heather Gornik, John Bartholomew, Mehdi Shishehbor, Frank Peacock, Douglas Joseph, Soo Hyum Kim, Natalia Fendrikova Mahlay, Daniel Clair, Sean Lyden, Baljendra Kapoor, Gordon McLennon, Gregory Pierce, James Newman, James Spain, Amanjiit Gill, Aaron Hamilton, Anthony Rizzo, Woosup Park, Alan Dietzek, Ira Galin, Dahlia Plummer, Richard Hsu, Patrick Broderick, Andrew Keller, Sameer Sayeed, Dennis Slater, Herb Lustberg, Jan Akus, Robert Sidman, Mandeep Dhami, Phillip Kohanski, Anca Bulgaru, Renuka Dulala, James Burch, Dinesh Kapur, Jie Yang, Mark Ranson, Alan Wladis, David Varnagy, Tarek Mekhail, Robert Winter, Manuel Perez-Izquierdo, Stephen Motew, Robin Royd-Kranis, Raymond Workman, Scott Kribbs, Gerald Hogsette, Phillip Moore, Bradley Thomason, William Means, Richard Bonsall, John Stewart, Daniel Golwya, Ezana Azene, Wayne Bottner, William Bishop, Dave Clayton, Lincoln Gundersen, Jody Riherd, Irina Shakhnovich, Kurt Ziegelbein, Thomas Chang, Karun Sharma, Sandra Allison, Fil Banovac, Emil Cohen, Brendan Furlong, Craig Kessler, Mike McCullough, Jim Spies, Judith Lin, Scott Kaatz, Todd Getzen, Joseph Miller, Scott Schwartz, Loay Kabbani, David McVinnie, John Rundback, Joseph Manno, Richard Schwab, Randolph Cole, Kevin Herman, David Singh, Ravit Barkama, Amish Patel, Anthony Comerota, John Pigott, Andrew Seiwert, Ralph Whalen, Todd Russell, Zakaria Assi, Sahira Kazanjian, Jonathan Yobbagy, Brian Kaminski, Allan Kaufman, Garett Begeman, Robert DiSalle, Subash Thakur, Marc Jacquet, Thomas Dykes, Joseph Gerding, Christopher Baker, Mark Debiasto, Derek Mittleider, George Higgins, Steven Amberson, Roger Pezzuti, Thomas Gallagher, Robert Schainfeld, Stephan Wicky, Sanjeeva Kalva, Gregory Walker, Gloria Salazar, Benjamin Pomerantz, Virenda Patel, Christopher Kabrhel, Shams Iqbal, Suvranu Gangull, Rahmi Oklu, Scott Brannan, Sanjay Misra, Haraldur Bjarnason, Aneel Ashrani, Michael Caccavale, Chad Fleming, Jeremy Friese, John Heit, Manju Kalra, Thanila Macedo, Robert McBane, Michael McKusick, Andrew Stockland, David Woodrum, Waldemar Wysokinski, Adarsh Verma, Andrew Davis, Jerry Chung, David Nicker, Brian Anderson, Robert Stein, Michael Weiss, Parag Patel, William Rilling, Sean Tutton, Robert Hieb, Eric Hohenwalter, M. Riccardo Colella, James Gosset, Sarah White, Brian Lewis, Kellie Brown, Peter Rossi, Gary Seabrook, Marcelo Guimaraes, J. Bayne Selby, William McGary, Christopher Hannegan, Jacob Robison, Thomas Brothers, Bruce Elliott, Nitin Garg, M. Bret Anderson, Renan Uflacker, Claudio Schonholz, Laurence Raney, Charles Greenberg, John Kaufman, Frederick Keller, Kenneth Kolbeck, Gregory Landry, Erica Mitchell, Robert Barton, Thomas DeLoughery, Norman Kalbfleisch, Renee Minjarez, Paul Lakin, Timothy Liem, Gregory Moneta, Khashayar Farsad, Ross Fleischman, Loren French, Vasco Marques, Yasir Al−Hassani, Asad Sawar, Frank Taylor, Rajul Patel, Rahul Malhotra, Farah Hashemi, Marvin Padnick, Melissa Gurley, Fred Cucher, Ronald Sterrenberg, G. Reshmaal Deepthi, Gomes Cumaranatunge, Sumit Bhatla, Darick Jacobs, Eric Dolen, Pablo Gamboa, L. Mark Dean, Thomas Davis, John Lippert, Sanjeev Khanna, Brian Schirf, Jeffrey Silber, Donald Wood, J. Kevin McGraw, Lucy LaPerna, Paul Willette, Timothy Murphy, Joselyn Cerezo, Rajoo Dhangana, Sun Ho Ahn, Gregory Dubel, Richard Haas, Bryan Jay, Ethan Prince, Gregory Soares, James Klinger, Robert Lambiase, Gregory Jay, Robert Tubbs, Michael Beland, Chris Hampson, Ryan O'Hara, Chad Thompson, Aaron Frodsham, Fenwick Gardiner, Abdel Jaffan, Lawrence Keating, Abdul Zafar, Radica Alicic, Rodney Raabe, Jayson Brower, David McClellan, Thomas Pellow, Christopher Zylak, Joseph Davis, M. Kathleen Reilly, Kenneth Symington, Camerson Seibold, Ryan Nachreiner, Daniel Murray, Stephen Murray, Sandeep Saha, Gregory Luna, Kim Hodgson, Robert McLafferty, Douglas Hood, Colleen Moore, David Griffen, Darren Hurst, David Lubbers, Daniel Kim, Brent Warren, Jeremy Engel, D.P. Suresh, Eric VanderWoude, Rahul Razdan, Mark Hutchins, Terry Rounsborg, Madhu Midathada, Daniel Moravec, Joni Tilford, Joni Beckman, Mahmood Razavi, Kurt Openshaw, D. Preston Flanigan, Christopher Loh, Howard Dorne, Michael Chan, Jamie Thomas, Justin Psaila, Michael Ringold, Jay Fisher, Any Lipcomb, Timothy Oskin, Brandt Wible, Brendan Coleman, David Elliott, Gary Gaddis, C. Doug Cochran, Kannan Natarajan, Stewart Bick, Jeffrey Cooke, Ann Hedderman, Anne Greist, Lorrie Miller, Brandon Martinez, Vincent Flanders, Mark Underhill, Lawrence Hofmann, Daniel Sze, William Kuo, John Louie, Gloria Hwang, David Hovsepian, Nishita Kothary, Caroline Berube, Donald Schreiber, Brooke Jeffrey, Jonathan Schor, Jonathan Deitch, Kuldeep Singh, Barry Hahn, Brahim Ardolic, Shilip Gupta, Riyaz Bashir, Angara Koneti Rao, Manish Garg, Pravin Patil, Chad Zack, Gary Cohen, Frank Schmieder, Valdimir Lakhter, David Sacks, Robert Guay, Mark Scott, Karekin Cunningham, Adam Sigal, Terrence Cescon, Nick Leasure, Thiruvenkatasamy Dhurairaj, Patrick Muck, Kurt Knochel, Joann Lohr, Jose Barreau, Matthew Recht, Jayapandia Bhaskaran, Ranga Brahmamdam, David Draper, Apurva Mehta, James Maher, Melhem Sharafuddin, Steven Lentz, Andrew Nugent, William Sharp, Timothy Kresowik, Rachel Nicholson, Shiliang Sun, Fadi Youness, Luigi Pascarella, Charles Ray, Martha-Gracia Knuttinen, James Bui, Ron Gaba, Valerie Dobiesz, Ejaz Shamim, Sangeetha Nimmagadda, David Peace, Aarti Zain, Alison Palumto, Ziv Haskal, Jon Mark Hirshon, Howard Richard, Avelino Verceles, Jade Wong-You-Chong, Bertrand Othee, Rahul Patel, Bogdan Iliescu, David Williams, Joseph Gemmete, Wojciech Cwikiel, Kyung Cho, James Schields, Ranjith Vellody, Paula Novelli, Narasimham Dasika, Thomas Wakefield, Jeffrey Desmond, James Froehlich, Minhajuddin Khaja, David Hunter, Jafar Golzarian, Erik Cressman, Yvonne Dotta, Nate Schmiechen, John Marek, David Garcia, Isaac Tawil, Mark Langsfeld, Stephan Moll, Matthew Mauro, Joseph Stavas, Charles Burke, Robert Dixon, Hyeon Yu, Blair Keagy, Kyuny Kim, Raj Kasthuri, Nigel Key, Michael Makaroun, Robert Rhee, Jae−Sung Cho, Donald Baril, Luke Marone, Margaret Hseih, Kristian Feterik, Roy Smith, Geetha Jeyabalan, Jennifer Rogers, Russel Vinik, Dan Kinikini, Larry Kraiss, Michelle Mueller, Robert Pendleton, Matthew Rondina, Mark Sarfati, Nathan Wanner, Stacy Johnson, Christy Hopkins, Daniel Ihnat, John Angle, Alan Matsumoto, Nancy Harthun, Ulku Turba, Wael Saad, Brian Uthlaut, Srikant Nannapaneni, David Ling, Saher Sabri, John Kern, B. Gail Macik, George Hoke, Auh Wahn Park, James Stone, Benjamin Sneed, Scott Syverud, Kelly Davidson, Aditya Sharma, Luke Wilkins, Carl Black, Mark Asay, Daniel Hatch, Robert Smilanich, Craig Patten, S. Douglas Brown, Ryan Nielsen, William Alward, John Collins, Matthew Nokes, Randolph Geary, Matthew Edwards, Christopher Godshall, Pavel Levy, Ronald Winokur, Akhilesh Sista, David Madoff, Kyungmouk Lee, Bradley Pua, Maria DeSancho, Raffaele Milizia, Jing Gao, Gordon McLean, Sanualah Khalid, Larry Lewis, Nael Saad, Mark Thoelke, Robert Pallow, Seth Klein, Gregorio Sicard, Heather L. Gornik, Jim Julian, Stephen Kee, Lawrence Lewis, Elizabeth Magnuson, and Timothy P. Murphy

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Mechanical Thrombolysis, medicine.medical_treatment, Catheter directed thrombolysis, 030204 cardiovascular system & hematology, Iliac Vein, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, Quality of life, Randomized controlled trial, law, Surveys and Questionnaires, Internal medicine, Epidemiology, Medicine, Humans, In patient, Thrombolytic Therapy, 030212 general & internal medicine, cardiovascular diseases, Thrombus, Venous Thrombosis, business.industry, Thrombolysis, Femoral Vein, Middle Aged, medicine.disease, United States, humanities, 3. Good health, Venous thrombosis, Treatment Outcome, Quality of Life, Female, Surgery, Cardiology and Cardiovascular Medicine, business
Abstract

After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P .0001) and 6 months (8.8; P .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Published
2020

7. Evidence for the continued transmission of parvovirus B19 in patients with bleeding disorders treated with plasma-derived factor concentrates

Author

J Michael, Soucie, Paul E, Monahan, Roshni, Kulkarni, Christine, De Staercke, Michael, Recht, Meera B, Chitlur, Ralph, Gruppo, W Craig, Hooper, Craig, Kessler, Marilyn J, Manco-Johnson, Jerry, Powell, Meredith, Pyle, Brenda, Riske, Hernan, Sabio, and Sean, Trimble

Subjects
Male, Parvoviridae Infections, Parvovirus B19, Human, Humans, Female, Hemophilia A, Blood Coagulation Factors
Published
2013

9. Contributors

Author

Aryeh M. Abeles, Paolo Aglietti, Azhar A. Ali, Annunziato Amendola, Allen F. Anderson, Christian Noel Anderson, Jason D. Archibald, Elizabeth Arendt, Jean-Noël Argenson, Amy F. Austin, Bernard R. Bach, David Backstein, Geoffrey S. Baer, Sarvottam Bajaj, Andrea Baldini, Mark A. Baldwin, Sue Barber-Westin, Joseph Barker, Christopher P. Beauchamp, Martin Bédard, Keith R. Berend, Richard A. Berger, Thomas Bernasek, Daniel J. Berry, Jack M. Bert, Kevin F. Bonner, Adam C. Brekke, Karen K. Briggs, Claire L. Brockett, Michael K. Brooks, James A. Browne, Brandon J. Bryant, Jarett S. Burak, Alissa Burge, Charles Bush-Joseph, Asokumar Buvanendran, John Callaghan, Tom R. Carter, Eli Chen, Anikar Chhabra, Constance R. Chu, Randy Clark, Henry D. Clarke, David E. Cohen, Brian J. Cole, Thomas M. Coon, John H. Currier, Fred D. Cushner, Diane L. Dahm, Timothy A. Damron, Joseph P. DeAngelis, Bridget M. Deasy, David DeJour, Craig J. Della Valle, A. Lee Dellon, Guillaume Demey, Douglas A. Dennis, Ezra Deutsch, Ian D. Dickey, David R. Diduch, Mark E. Easley, Kostas Economopoulos, Gerard A. Engh, Gregory C. Fanelli, Jack Farr, Christopher M. Farrell, Thomas K. Fehring, Julian Feller, Jonathan T. Finnoff, John Fisher, Wolfgang Fitz, Clare K. Fitzpatrick, John P. Fletcher, John M. Flynn, Andrew G. Franks, Richard J. Friedman, Nicole A. Friel, Freddie H. Fu, John P. Fulkerson, Robert Kyle Fullick, Theodore J. Ganley, Donald S. Garbuz, Burhan Gharaibeh, Thomas J. Gill, Maria S. Goddard, Andreas Gomoll, Carlos Gonzalez, Christopher R. Gooding, Robert C. Grumet, F. Winston Gwathmey, Steve Haas, Mahmoud Hafez, George J. Haidukewych, Christopher A. Hajnik, Arlen D. Hanssen, Christopher D. Harner, Joseph M. Hart, William L. Healy, Peter F. Heeckt, Sarah E. Henry, Benton E. Heyworth, Richard Y. Hinton, Aaron A. Hofmann, Siegfried Hofmann, Ginger E. Holt, Terese T. Horlocker, Stephen M. Howell, Johnny Huard, Catherine Hui, Christophe Hulet, Maury L. Hull, Marc W. Hungerford, Anthony F. Infante, John N. Insall, David J. Jacofsky, James G. Jarvis, Louise Jennings, Charles E. Johnston, V. Karthik Jonna, Thomas Keller, Donna R. Kesselman, Craig Kessler, Saurabh Khakharia, Harpal S. Khanuja, Raymond H. Kim, Sung Jae Kim, Yair D. Kissin, Kevin Klingele, Mininder S. Kocher, Richard D. Komistek, Gabrielle P. Konin, Sandra L. Kopp, Nathan Kopydlowski, Dennis Kramer, Christopher M. Kuenze, Paul F. Lachiewicz, Jason E. Lang, Joshua R. Langford, Robert F. LaPrade, Peter J. Laz, Matthew Leidl, James M. Leone, Filip Leszko, David Levi, Gabriel Levi, Randall J. Lewis, Martin Lind, Eric M. Lindvall, David R. Lionberger, Frank A. Liporace, Martin Logan, Adolph V. Lombardi, William J. Long, Jess H. Lonner, Sébastien Lustig, Steven Lyons, Travis G. Maak, Jeffrey A. Macalena, Samuel D. Madoff, Shinichi Maeno, Robert A. Magnussen, Suzanne A. Maher, Mohamed R. Mahfouz, Sabine Mai, Patrick G. Marinello, J. Bohannon Mason, Bassam A. Masri, Henry Masur, Kevin R. Math, Richard C. Mather, Kenneth B. Mathis, Shuichi Matsuda, Jeremy McCandless, Kristen E. McClure, R. Michael Meneghini, Mark Miller, Douglas Mintz, Michael A. Mont, Claude T. Moorman, Michael J. Morris, William B. Morrison, Kenneth R. Morse, John Kyle P. Mueller, Thomas Muellner, David Murray, Volker Musahl, Michael D. Neel, Joshua Nelson, Michael P. Nett, Philippe Neyret, Philip C. Noble, Frank R. Noyes, Mary I. O’Connor, Matthew E. Oetgen, Mark W. Pagnano, Christopher J. Palestro, Sebastien Parratte, Brian S. Parsley, Nilesh Patil, Henrik B. Pedersen, Lars Peterson, Michael H. Pillinger, Leo Pinczewski, William R. Post, Sridhar R. Rachala, Craig S. Radnay, Adam J. Rana, R. Lor Randall, Robert S. Reiffel, Michael D. Ries, Samuel P. Robinson, Scott A. Rodeo, William G. Rodkey, Jose Rodriquez, Gregory J. Roehrig, Aaron G. Rosenberg, Pamela B. Rosenthal, Paul J. Rullkoetter, Paulo R.F. Saggin, Lucy Salmon, Roy Sanders, Robert C. Schenck, Oliver S. Schindler, Verena M. Schreiber, Richard D. Scott, Susan Craig Scott, W. Norman Scott, Giles R. Scuderi, Ari D. Seidenstein, Jon K. Sekiya, Elvire Servien, Erik P. Severson, Nicholas A. Sgaglione, Adrija Sharma, Seth L. Sherman, Michael S. Shin, Werner E. Siebert, Rafael J. Sierra, C. Van Sikes, David L. Skaggs, Gideon P. Smith, Gary E. Solomon, Kurt P. Spindler, Andrew I. Spitzer, Bryan D. Springer, J. Richard Steadman, Kelly Stets, Anna L. Stevens, James B. Stiehl, Eric J. Strauss, Michael Stuart, S. David Stulberg, Eric Tannenbaum, Dean C. Taylor, Kimberly Templeton, Stephen R. Thompson, Thomas Thornhill, Gehron Treme, Alfred J. Tria, Kimberly A. Turman, Hans K. Uhthoff, Anthony S. Unger, Thomas Parker Vail, Douglas W. Van Citters, Geoffrey S. Van Thiel, Haris S. Vasiliadis, Vincent J. Vigorita, Kelly G. Vince, Bruno Violante, James E. Voos, Shail Vyas, Daniel M. Walz, David Warwick, Nicholas P. Webber, Jennifer Weiss, Kurt R. Weiss, Barbara N. Weissman, Leo A. Whiteside, Thomas L. Wickiewicz, Bryan S. Williams, Riley J. Williams, Yi-Meng Yen, Hong Zhang, Sumesh M. Zingde, and Adam C. Zoga

Published
2012
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10. Clinical roundtable monograph. The oncologist's role in management of venous thromboembolism

Author

Howard, Liebman, Alok, Khorana, and Craig, Kessler

Subjects
Risk Factors, Neoplasms, Humans, Venous Thromboembolism, Medical Oncology, Physician's Role
Abstract

Thromboembolism is the second leading cause of death in cancer patients. Patients with venous thromboembolism (VTE) and malignancy have a significantly higher probability of death. Pulmonary embolism can lead to a fatal outcome, and this condition often goes undiagnosed in cancer patients despite the presence of symptoms. Risk of VTE is increased by a number of clinical factors, which can be patient-derived, cancer-related, and treatment-related. Increasingly, clinicians are seeking predictable biomarkers to identify those patients at the greatest risk. To that end, a newly developed and validated predictive risk model may help identify patients who could benefit from prophylaxis. In addition, serum levels of coagulation cascade factors may predict the survival rate of cancer patients; elevated D-dimer levels are associated with decreased survival time. Anticoagulants, particularly low-molecular-weight heparin, can be useful in preventing the recurrence of clots in cancer patients with VTE. Current and future investigations are aimed at determining if prophylaxis with anticoagulants can improve patient survival. Future management strategies may involve the use of low-molecular-weight heparin or other novel anticoagulants as part of palliative care for high-risk patients. Although treatment with low-molecular-weight heparin can significantly reduce the risks of clots, the impact on cancer survival is unclear.

Published
2011

12. A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura

Author

Paul D, Mintz, Anne, Neff, Malcolm, MacKenzie, Lawrence T, Goodnough, Christopher, Hillyer, Craig, Kessler, Keith, McCrae, Jay E, Menitove, Barry S, Skikne, Lloyd, Damon, Ileana, Lopez-Plaza, Charles, Rouault, Kendall P, Crookston, Richard J, Benjamin, James, George, Jin-Sying, Lin, Laurence, Corash, and Maureen G, Conlan

Subjects
Adult, Aged, 80 and over, Male, Infection Control, Time Factors, Adolescent, Plasma Exchange, Purpura, Thrombotic Thrombocytopenic, Ultraviolet Rays, Remission Induction, Middle Aged, Blood Coagulation Factors, Disease-Free Survival, Double-Blind Method, Recurrence, Furocoumarins, Humans, Female, Child, Aged
Abstract

Photochemical treatment of fresh-frozen plasma (FFP) with amotosalen and ultraviolet (UV) A light (PCT FFP) results in inactivation of a broad spectrum of pathogens while retaining coagulation factor activity, antithrombotic proteins, and von Willebrand factor-cleaving protease (VWF-CP) activity.A randomized, controlled, double-blind Phase III trial was conducted with PCT FFP or control FFP for therapeutic plasma exchange (TPE) in patients with thrombotic thrombocytopenic purpura (TTP). Owing to the rarity of this diagnosis, the trial was not powered to demonstrate small differences between treatment groups. Patients were treated with study FFP for a maximum of 35 days until remission was achieved (for a maximum of 30 daily study TPEs with no remission) plus an additional 5 days after remission.Among the 35 patients treated, the primary endpoint, remission within 30 days, was achieved by 14 of 17 (82%) PCT patients and 16 of 18 (89%) control patients (p = 0.658) The 90 percent confidence interval for treatment difference in remission rate for test - control was (-0.291 to 0.163). Time to remission, relapse rates, time to relapse, total volume and number of FFP units exchanged, and number of study TPEs were not significantly different between groups. Improvement in VWF-CP and inhibitors was similar for both groups. The overall safety profile of PCT FFP was similar to control FFP. No antibodies to amotosalen neoantigens were detected.The comparable results between treatment groups observed from this small trial suggest that TPE with PCT FFP was safe and effective for treatment of TTP.

Published
2006

13. Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies

Author

Pedro, de Alarcon, Richard, Benjamin, Marion, Dugdale, Craig, Kessler, Rinah, Shopnick, Peter, Smith, Thomas, Abshire, Julie, Hambleton, Prasad, Matthew, Idith, Ortiz, Alice, Cohen, Barbara A, Konkle, Michael, Streiff, Martin, Lee, David, Wages, and Laurence, Corash

Subjects
Adult, Male, Hemostasis, Adolescent, Infant, Blood Coagulation Disorders, Middle Aged, Blood Coagulation Factors, Plasma, Blood Preservation, Child, Preschool, Furocoumarins, Prothrombin Time, Humans, Blood Transfusion, Female, Child, Aged
Abstract

Photochemical treatment (PCT) with amotosalen HCl (S-59) was developed to inactivate pathogens and white blood cells in plasma (PCT-FFP) used for transfusion support.An open-label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT-FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT-FFP transfusions.Thirty-four patients received 107 transfusions of PCT-FFP for kinetic studies or therapeutic indications (mean dose, 12.8 +/- 8.5 mL/kg). Incremental factor recoveries ranged from 0.9 to 2.4 IU per dL per IU per kg (FII, FV, FVII, FX, FXI, and protein C). Mean pretransfusion PT (20.7 +/- 22.2 sec) corrected after PCT-FFP (13.8 +/- 2.4 sec, p0.001). Mean pretransfusion PTT (51.2 +/- 29.3 sec) corrected after PCT-FFP (32.0 +/- 5.1 sec, p0.001). Thirteen patients required 77 transfusions for therapeutic indications. PCT-FFP provided effective hemostasis and was well tolerated.Replacement coagulation factors in PCT-FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.

Published
2005

14. Initial clinical trial of oral TAC-101, a novel retinoic acid receptor-alpha selective retinoid, in patients with advanced cancer

Author

John L. Marshall, Waun Ki Hong, William Petros, Naiyer A. Rizvi, Michael J. Hawkins, Jonathan M. Kurie, Elizabeth Ness, Helena Jacobs, Wayne D. Brenckman, Craig Kessler, and Jin S. Lee

Subjects
myalgia, Adult, Male, Cancer Research, medicine.medical_specialty, Trimethylsilyl Compounds, Maximum Tolerated Dose, Metabolic Clearance Rate, medicine.medical_treatment, Retinoic acid, Antineoplastic Agents, Gastroenterology, Benzoates, chemistry.chemical_compound, Pharmacokinetics, Oral administration, Internal medicine, Neoplasms, Thromboembolism, medicine, Humans, Aged, Chemotherapy, business.industry, Hypertriglyceridemia, Middle Aged, medicine.disease, Surgery, Oncology, chemistry, Retinoic acid receptor alpha, Toxicity, Female, medicine.symptom, business
Abstract

PURPOSE: The goals of this study were to determine the safety, toxicity, and pharmacokinetics of TAC-101, a novel synthetic retinoic acid receptor-alpha (RAR-α) selective retinoid, in patients with advanced cancer. PATIENTS AND METHODS: Twenty-nine patients at two centers received oral TAC-101 at doses ranging from 12 to 34 mg/m2/d. Pharmacokinetic sampling was performed on days 1 and 28. RESULTS: The most frequent toxicities were myalgia/arthralgia, fatigue, and triglyceridemia. No dose-limiting toxicities were observed within the first 28 days up to 28 mg/m2. However, seven of 21 patients experienced venous thromboembolic events (VTEs) during TAC-101 treatment. Eight additional patients who received 34 mg/m2 were treated after a hypercoagulable work-up to exclude potential risk factors for VTE, and two of eight patients subsequently experienced VTEs. The maximum tolerated dose was exceeded at 34 mg/m2/d within the first 28 days, with one grade 3 hypertriglyceridemia, two grade 3 myalgia/arthralgia, and one grade 3 fatigue. One patient with advanced non–small-cell lung cancer had a complete response. No other responses were observed. No autoinduction of metabolism was observed with dosing over 28 days. CONCLUSION: This is the first human clinical study with TAC-101, a RAR-α selective retinoid. Musculoskeletal toxicity and hypertriglyceridemia were observed characteristics of previously studied retinoids. The recommended phase II dose is 24 mg/m2 with this treatment schedule. Alternative treatment schedules and prospective evaluation of thrombotic risk will be investigated in subsequent studies.

Published
2002

15. Haemophilia2010

Author

Christine, Lee, Craig, Kessler, Mike, Makris, and Judith, Barback

Subjects
Publishing, Internet, Hematology, General Medicine, Genetics (clinical)
Published
2010
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16. PFA-100 system: a new method for assessment of platelet dysfunction

Author

Eberhard Mammen, Philip Comp, Robert Gosselin, Charles Greenberg, W. Hoots, Craig Kessler, Edward Larkin, Darla Liles, and Diane Nugent

Subjects
Adult, Blood Platelets, Male, medicine.medical_specialty, Bleeding Time, Adolescent, Platelet Aggregation, Platelet Function Tests, Sensitivity and Specificity, Bleeding time, Predictive Value of Tests, Internal medicine, Thrombocytopathy, medicine, Von Willebrand disease, Humans, Platelet, Abnormal Platelet, Aged, Hemostasis, medicine.diagnostic_test, Aspirin, business.industry, PFA-100, Hematology, Equipment Design, Middle Aged, medicine.disease, Surgery, von Willebrand Diseases, Predictive value of tests, Cardiology, Female, Blood Platelet Disorders, Cardiology and Cardiovascular Medicine, business, Thrombasthenia
Abstract

The PFA-100 system is a platelet function analyzer designed to measure platelet-related primary hemostasis. The instrument uses two disposable cartridges: a collagen/epinephrine (CEPI) and a collagen/ADP (CADP) cartridge. Previous experience has shown that CEPI cartridges detect qualitative platelet defects, including acetylsalicylic acid (ASA)-induced abnormalities, while CADP cartridges detect only thrombocytopathies and not ASA use. In this seven-center trial, 206 healthy subjects and 176 persons with various platelet-related defects, including 127 ASA users, were studied. The platelet function status was determined by a platelet function test panel. Comparisons were made as to how well the defects were identified by the PFA-100 system and by platelet aggregometry. The reference intervals for both cartridges, testing the 206 healthy subjects, were similar to values described in smaller studies in the literature [mean closure time (CT) 132 s for CEPI and 93 s for CADP]. The use of different lot numbers of cartridges or duplicate versus singleton testing revealed no differences. Compared with the platelet function status, the PFA-100 system had a clinical sensitivity of 94.9% and a specificity of 88.8%. For aggregometry, a sensitivity of 94.3% and a specificity of 88.3% were obtained. These values are based on all 382 specimens. A separate analysis of sensitivity by type of platelet defect, ASA use versus congenital thrombocytopathies, revealed for the PFA-100 system a 94.5% sensitivity in identifying ASA users and a 95.9% sensitivity in identifying the other defects. For aggregometry, the values were 100% for ASA users and 79.6% for congenital defects. Analysis of concordance between the PFA-100 system and aggregometry revealed no difference in clinical sensitivity and specificity between the systems (p > 0.9999). The overall agreement was 87.5%, with a Kappa index of 0.751. The two tests are thus equivalent in their ability to identify normal and abnormal platelet defects. Testing 126 subjects who took 325 mg ASA revealed that the PFA-100 system (CEPI) was able to detect 71.7% of ASA-induced defects with a positive predictive value of 97.8%. The overall clinical accuracy of the system, calculated from the area under the ROC curve, was 0.977. The data suggest that the PFA-100 system is highly accurate in discriminating normal from abnormal platelet function. The ease of operation of the instrument makes it a useful tool to use in screening patients for platelet-related hemostasis defects.

Published
1998

18. Haemophilia 2012

Author

Christine A. Lee, Craig Kessler, Mike Makris, and Samantha Gough

Subjects
Hematology, General Medicine, Genetics (clinical)
Published
2011
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19. Haemophilia 2011

Author

Christine, Lee, Craig, Kessler, Mike, Makris, and Samantha, Gough

Subjects
Publishing, Hematology, General Medicine, Blood Coagulation Disorders, Online Systems, Genetics (clinical)
Published
2010
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21. Correspondence

Author

Kim J. Chillag, Charles W. Francis, Saara Totterman, Allen D. Boyd, Victor J. Marder, Kristin M. Liebert, Vincent D. Pellegrini, Bernard N. Stulberg, David C. Ayers, Aaron Rosenberg, Craig Kessler, and Norman A. Johanson

Subjects
Orthopedics and Sports Medicine, Surgery, General Medicine
Published
1998
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22. Correspondence

Author

Kenneth J. Hoek, Charles W. Francis, Saara Totterman, Allen D. Boyd, Victor J. Marder, Kristin M. Liebert, Vincent D. Pellegrini, Bernard N. Stulberg, David C. Ayers, Aaron Rosenberg, Craig Kessler, and Norman A. Johanson

Subjects
Orthopedics and Sports Medicine, Surgery, General Medicine
Published
1998
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23. Isolated Richter’s transformation of the brain.

Author

Anto Bagic, Craig Kessler, and Carlo Tornatore

Abstract

Abstract  Patients with B-cell chronic lymphocytic leukemia (CLL) have an increased risk of second malignancy and may develop diffuse large-cell non-Hodgkin’s lymphoma (DLCL) also known as Richter’s syndrome (RS). Only seven cases of isolated brain RS without evidence of systemic lymphoma have been reported to date. We describe a case of isolated DLCL of the brain in a 58-year-old female patient with a 3 year history of B-cell CLL. The patient presented with falls due to left leg paresis and showed non-specific neuroimaging findings. Brain biopsy confirmed the diagnosis of DLCL and CLL restaging failed to demonstrate evidence of RS outside the CNS. The patient was treated with whole brain radiation therapy and was discharged 4 weeks later on weekly rituximab infusions. This report extends the previous experience by providing a detailed clinical, neuroradiological and pathological description of isolated RS of the brain. Early identification and timely CNS directed treatment may alter morbidity and positively influence quality of life. [ABSTRACT FROM AUTHOR]

Published
2007
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24. Perspectives on treatment of acute pulmonary embolism with tissue plasminogen activator

Author

Samuel Goldhaber, John Markis, Craig Kessler, Michael Meyerovitz, Ducksoo Kim, Douglas Vauchan, Andrew Selwyn, Joseph Loscalzo, Douglas Dawley, G.V.R.K. Sharma, Arthur Sasahara, Elliott Grossbard, and Eugene Braunwald

Subjects
Adult, Pathology, medicine.medical_specialty, Fibrinogen, Tissue plasminogen activator, law.invention, Fibrin Fibrinogen Degradation Products, law, medicine, Humans, Pulmonary Wedge Pressure, Pulmonary wedge pressure, Clinical Trials as Topic, medicine.diagnostic_test, business.industry, Heparin, Angiography, Hematology, medicine.disease, Recombinant Proteins, Pulmonary embolism, Tissue Plasminogen Activator, Recombinant DNA, Female, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, medicine.drug
Published
1987

25. Prevention of deep-vein thrombosis after total hip arthroplasty. Comparison of warfarin and dalteparin

Author

Craig Kessler, Aaron G. Rosenberg, Saara Totterman, Norman A. Johanson, Victor J. Marder, Charles W. Francis, Vincent D. Pellegrini, David C. Ayers, Kristin M. Liebert, Allen D. Boyd, and Bernard N. Stulberg

Subjects
Dalteparin, Male, medicine.medical_specialty, medicine.drug_class, Premedication, Deep vein, Blood Loss, Surgical, Venography, Low molecular weight heparin, Hemorrhage, Hematocrit, Postoperative Complications, medicine, Humans, Orthopedics and Sports Medicine, Prospective Studies, Prospective cohort study, Dalteparin sodium, medicine.diagnostic_test, business.industry, Warfarin, Anticoagulants, General Medicine, Middle Aged, Thrombophlebitis, medicine.disease, Thrombosis, Surgery, medicine.anatomical_structure, Anesthesia, Female, Hip Prosthesis, business, medicine.drug
Abstract

The effectiveness and safety of warfarin were compared with those of a low-molecular-weight heparin (dalteparin) for the prevention of deep-vein thrombosis after total hip arthroplasty in a prospective, randomized, multi-institutional trial. Patients who were older than eighteen years of age and were scheduled to have an elective primary or revision total hip arthroplasty were eligible; 580 patients were randomized, 550 had the operation and received prophylaxis, and 382 had evaluable venograms. Prophylaxis was provided either with warfarin beginning the night before the operation or with dalteparin beginning two hours before the operation and was continued until venography was performed. Bleeding was assessed on the basis of intraoperative blood loss, transfusion requirements, a decrease in hematocrit, and clinically identified bleeding complications. The prevalence of deep-vein thrombosis was found to be significantly lower in the patients who had received dalteparin than in those who had received warfarin (twenty-eight [15 per cent] of 192 patients compared with forty-nine [26 per cent] of 190 patients; p = 0.006). Deep-vein thrombosis occurred in the calf veins of twenty-one patients (11 per cent) who had received dalteparin and of forty-three patients (23 per cent) who had received warfarin; this difference was significant (p = 0.003). Proximal deep-vein thrombosis occurred in ten patients (5 per cent) who had received dalteparin and in sixteen patients (8 per cent) who had received warfarin; however, with the numbers available, no significant difference could be detected (p = 0.185). We also could not detect a significant difference with regard to the intraoperative and postoperative blood loss, the decrease in hematocrit, and the prevalence of major bleeding complications between the two groups; however, the patients who had received dalteparin had a significantly higher prevalence of bleeding complications involving the operative site (p = 0.03), and a significantly greater percentage required postoperative transfusions (p = 0.001). We concluded that preoperative prophylaxis with dalteparin is significantly more effective than that with warfarin in preventing deep-vein thrombosis after total hip arthroplasty. The greater effectiveness of dalteparin must be considered, however, in light of an increased need for postoperative transfusions and an increase in the prevalence of wound-related bleeding complications.

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