July 12, 2016 • By
CHICAGO—A lupus expert recently issued a call for action to improve outcomes of lupus clinical trials, a field that has had so many failed potential therapies that he said it seems to be “cursed.”
Richard Furie, MD, chief of rheumatology at Northwell Health in New York, said at the ACR’s 2016 State-of-the-Art Clinical Symposium that the field has had “just three wins, and I can’t tell you how many losses.”
The three achievements he counted are the BLISS-52 and BLISS-76 (Belimumab in Subjects with Systemic Lupus Erythematosus) trials, which led to the approval of belimumab, and the maintenance phase of ALMS (Aspreva Lupus Management Study), which found that mycophenolate mofetil was superior to azathioprine for lupus nephritis (LN) maintenance therapy.1,2
December 16, 2015 • By Mary Beth Nierengarten
The Rheumatologist (ACR journal)
June 15, 2015 • By
Although close collaboration with a variety of specialists outside of rheumatology is important, you could make the case for rheumatologists and pulmonologists having to work together even more closely. If lung symptoms are severe and not under control,
However, the question sometimes is when to refer—even when there are not any evident lung symptoms and the patient’s rheumatic disease is well controlled with therapy.
Rheumatologists and pulmonologists have a great deal of clinical crossover for conditions like interstitial lung disease, pulmonary arterial hypertension in scleroderma and vasculitides (see sidebar, below). keep reading
June 15, 2015 • By Leonard H. Calabrese, DO, & Elizabeth Kirchner, MSN, CNP
It has been nearly 35 years since the original descriptions of what now is recognized as AIDS (the acquired immune deficiency syndrome), an advanced form of infection secondary to the human immunodeficiency virus (HIV). The epidemic of HIV infection remains the singular most dramatic epidemic of our generation and will likely remain with us for generations to come.
The disease itself (i.e., HIV infection) has been transformed from a highly fatal illness with a progressive course and no known therapy to a complex but manageable disease for those with access to antiviral therapy. Socially, the epidemic of HIV infection has changed from one of high visibility attended by fear and stigmatization to one that now has lost much of its exclusivity, affecting all segments of the population to some degree, albeit disproportionately.
Himal Lal, M.D et al.
N Engl J Med 2015; 372:2087-2096 May 28, 2015DOI: 10.1056/NEJMoa1501184
In previous phase 1–2 clinical trials involving older adults, a subunit vaccine containing varicella–zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response.
Full Text of Background…
We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (≥50 years of age), stratified according to age group (50 to 59, 60 to 69, and ≥70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults.
Full Text of Methods…
A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups.
Full Text of Results…
The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number, NCT01165177.)
Biologics: Targets and Therapy
Detert J, Klaus P Published Date May 2015 Volume 2015:9 Pages 35—43 DOI http://dx.doi.org/10.2147/BTT.S53361
Jacqueline Detert, Pascal Klaus
Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Abstract: Biologics, possibly in combination with a conventional disease-modifying antirheumatic drug (DMARD) – preferably methotrexate (MTX), are used in accordance with the recommendations of the international rheumatological societies. However, in clinical practice, this recommendation is often problematic, as many rheumatologists know from personal experience. The quality of life of the patient is affected mainly by drug-induced intolerances (eg, MTX). Thus, the acceptance of the patient to treatment is often so inadequate that a discontinuation of the drug is necessary. In daily practice, approximately 30% of patients with biological therapy receive no concomitant DMARD according to the register data.
Keywords: efficacy, safety, methotrexate, autoimmune disease