Gary S. Hoffman, MD; Maria C. Cid, MD; Karen E. Rendt-Zagar, MD; Peter A. Merkel, MD, MPH; Cornelia M. Weyand, MD; John H. Stone, MD, MPH; Carlo Salvarani, MD; Weichun Xu, PhD; Sudha Visvanathan, PhD; Mahboob U. Rahman, MD, PhD; for the Infliximab-GCA Study Group*
Steroid-sparing treatment would be valuable in giant cell arteritis (GCA) because most patients experience complications of glucocorticoid therapy. Case reports suggest that infliximab might be effective. Hoffman and colleagues randomly assigned 44 patients with GCA in glucocorticoid-induced remission to receive infliximab or placebo at 0, 2, and 6 weeks and every 8 weeks thereafter. Infliximab did not reduce rates of relapse or any secondary end point and is therefore unlikely to be useful in GCA.
Ann Intern Med. 2007;146(9):621-630. doi:10.7326/0003-4819-146-9-200705010-00004
Carlo Salvarani, MD; PierLuigi Macchioni, MD; Carlo Manzini, MD; Giuseppe Paolazzi, MD; Aldo Trotta, MD; Paolo Manganelli, MD; Marco Cimmino, MD; Roberto Gerli, MD; Maria Grazia Catanoso, MD; Luigi Boiardi, MD; Fabrizio Cantini, MD; Catherine Klersy, MD; Gene G. Hunder, MD
Some patients with polymyalgia rheumatica have a chronic relapsing course and require long-term glucocorticoid therapy. A small case series suggested that infliximab could reduce the glucocorticoid dose needed to induce and maintain remission. Salvarani and associates therefore randomly assigned 51 patients with newly diagnosed polymyalgia rheumatica to take placebo or infliximab at weeks 0, 2, 6, 14, and 22. All patients took prednisone in tapering doses. Relapse-free and recurrence-free survival did not differ at 52 weeks.
Ann Intern Med. 2007;146(9):631-639. doi:10.7326/0003-4819-146-9-200705010-00005
Wim A. van der Steeg, MD; S. Matthijs Boekholdt, MD, PhD; Evan A. Stein, MD, PhD; Karim El-Harchaoui, MD; Erik S.G. Stroes, MD, PhD; Manjinder S. Sandhu, PhD; Nicholas J. Wareham, MBBS, PhD; J. Wouter Jukema, MD, PhD; Robert Luben, BSc; Aeilko H. Zwinderman, PhD; John J.P. Kastelein, MD, PhD; Kay-Tee Khaw, MBBChir
The apolipoprotein B–apolipoprotein A-I (apo B–apo A-I) ratio is a strong risk factor for atherosclerotic cardiovascular disease. The researchers performed a case–control analysis of persons 45 to 79 years of age. They found that the apo B–apo A-I ratio is no better than conventional measures of risk prediction in distinguishing between people who later developed atherosclerotic cardiovascular disease and people who did not.
Ann Intern Med. 2007;146(9):640-648. doi:10.7326/0003-4819-146-9-200705010-00007
Kazuki Ikeda, MD; Hiroyuki Marusawa, MD, PhD; Yukio Osaki, MD; Takefumi Nakamura, MD, PhD; Naoto Kitajima, MD, PhD; Yukitaka Yamashita, MD, PhD; Masatoshi Kudo, MD, PhD; Tosiya Sato, PhD; Tsutomu Chiba, MD, PhD
Retrospective studies suggest that exposure to hepatitis B virus (HBV) may contribute to the development of hepatocellular carcinoma (HCC) in patients with cirrhosis who have hepatitis C virus (HCV). The investigators prospectively studied 845 patients with chronic HCV infection and evidence of occult HBV infection. Patients with HCV-related cirrhosis and antibody to hepatitis B core antigen (anti-HBc) were at increased risk for HCC. Presence of anti-HBc may indicate increased risk for HCC in patients with HCV-related cirrhosis.
Ann Intern Med. 2007;146(9):649-656. doi:10.7326/0003-4819-146-9-200705010-00008
Frank Andersohn, MD; Christine Konzen, MD; Edeltraut Garbe, MD, PhD
Drug-induced agranulocytosis is a rare but potentially serious adverse event. This systematic review of case reports involved 980 patients who were not receiving chemotherapy but developed possible drug-induced agranulocytosis. One hundred twenty-five drugs definitely or probably caused agranulocytosis. More than half of these cases involved 1 of 11 particular drugs. Fatal complications occurred in 10% of patients with a neutrophil count nadir less than 0.1 × 109 cells/L but only 3% of patients with higher neutrophil counts.
Ann Intern Med. 2007;146(9):657-665. doi:10.7326/0003-4819-146-9-200705010-00009
Joanne Lynn, MD; Mary Ann Baily, PhD; Melissa Bottrell, PhD, MPH; Bruce Jennings, MA; Robert J. Levine, MD; Frank Davidoff, MD; David Casarett, MD; Janet Corrigan, PhD, MBA; Ellen Fox, MD; Matthew K. Wynia, MD, MPH; George J. Agich, PhD; Margaret O'Kane, MHA; Theodore Speroff, PhD; Paul Schyve, MD; Paul Batalden, MD; Sean Tunis, MD; Nancy Berlinger, PhD, MDiv; Linda Cronenwett, PhD, RN; J. Michael Fitzmaurice, PhD; Nancy Neveloff Dubler, LLB; Brent James, MD, MStat
The Hastings Center convened leaders and scholars to define the relationship between the ethical protections for patients participating in quality improvement (QI) activities and the regulations protecting human subjects of research. The panelists asserted that most QI activities are not human subjects research and should not undergo review by an institutional review board (IRB). Instead, they called for appropriately calibrated supervision of QI activities. The group formulated criteria for classifying a project as QI, human subjects research, or both. They propose a customized IRB process for the overlap category.
Ann Intern Med. 2007;146(9):666-673. doi:10.7326/0003-4819-146-9-200705010-00155
Raashid Luqmani, DM
Hoffman and colleagues and Salvarani and associates added infliximab to corticosteroid therapy for giant cell arteritis and polymyalgia rheumatica, respectively, and found no measurable benefit. However, the studies enrolled a relatively small number of patients and so might have missed a substantial treatment effect. Because infliximab had no measurable benefit, tumor necrosis factor is not a logical target for treatment in these diseases. Corticosteroids remain the cornerstone of therapy.
Ann Intern Med. 2007;146(9):674-676. doi:10.7326/0003-4819-146-9-200705010-00011
Michael Berkwits, MD, MSCE, Deputy Editor; Eliseo Guallar, MD, PhD
van der Steeg and colleagues show that the apolipoprotein B–apolipoprotein A-I ratio does not improve overall prediction of coronary artery disease in a general population. In fact, newer risk factors rarely add much to predictions that use established risk measures, which is why clinicians should require rigorous proof of added value of any new risk factor before recommending widespread testing for it in routine clinical practice.
Ann Intern Med. 2007;146(9):677-679. doi:10.7326/0003-4819-146-9-200705010-00012
Christine Grady, RN, PhD
Lynn and colleagues report the results of a credible and timely project: an analysis of ethical requirements for QI activities and their relationship to regulations protecting human research subjects. They conclude that the QI activities that qualify as human subjects research and those that overlap with it should be supervised by specially convened institutional review boards. Yet, they have difficulty defining sharp borders between human subjects research and QI, which will pose problems for those who must decide what kind of review each activity requires.
Ann Intern Med. 2007;146(9):680-681. doi:10.7326/0003-4819-146-9-200705010-00156
Jeffrey M. Jacobson, MD; Barbara J. Turner, MD; Elias Abrutyn, MD
The SMART trial has shown that cycling HIV-infected patients on and off therapy as their CD4+ count rises or falls may further increase morbidity and all-cause mortality. Of note, cardiovascular disease and nonopportunistic cancer rather than opportunistic infections were the main causes of death in patients assigned to take a “drug holiday” when their CD4+ count was high. The study shows that antiretroviral-experienced persons should stay on HIV treatment. It also reminds us to try to prevent common organ diseases and nonopportunistic cancer that may be caused by poorly understood effects of HIV infection.
Ann Intern Med. 2007;146(9):682-683. doi:10.7326/0003-4819-146-9-200705010-00014
The Editors commemorate the career of Dr. Elias Abrutyn, a long-time associate editor of Annals of Internal Medicine.
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Peter Manu, MD
Ann Intern Med. 2007;146(9):639. doi:10.7326/0003-4819-146-9-200705010-00006
Tonya Fancher, MD; Richard Kravitz, MD
Ann Intern Med. 2007;146(9):ITC5-1. doi:10.7326/0003-4819-146-9-200705010-01005
Ann Intern Med. 2007;146(9):I-12. doi:10.7326/0003-4819-146-9-200705010-00001
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Ann Intern Med. 2007;146(9):I-59. doi:10.7326/0003-4819-146-9-200705010-00003
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