Sir William Osler, the father of modern medicine, said “the desire to take medicine is perhaps the greatest feature that separates man from animal.” Determination of the benefit of a medication can be challenging and includes a number of factors, such as pharmacologic activities on the disease pathophysiology, pharmacokinetic properties and patient characteristics.1,2 An additional,…
Creative Online Strategies for Rheumatologists to Track & Assess Emerging Clinical Trial Data
With extensive clinical trial data being published daily, how does a rheumatologist stay up to date on latest breakthroughs? Rheumatologists can leverage multiple online resources to stay informed and apply information to patient care…
Stem Cell Transplantation Benefits Patients with Scleroderma
A recently published study gives new insight into an innovative approach to treating patients with severe scleroderma and internal organ involvement. During the six-year study, researchers demonstrated the durability of the beneficial effects of stem cell transplantation in this patient population. Their data also suggest the treatment has the potential to renormalize the autoreactive immune system…
Tips for Surviving FDA Audits of Your Clinical Trials
SAN DIEGO—You come to work. The day is going well. Your clinical trials are moving along. Then you get the call: It’s the Federal Drug Administration (FDA), and they’re coming to audit in about a week. You might be struck by a sense of dread. But you don’t have to be, an expert said at…
Guidelines on Advice for Low Back Pain at Odds with Clinical Trial Results
NEW YORK (Reuters Health)—Advice is considered an effective treatment for acute low back pain (LBP), but neither clinical trials nor guidelines include adequate detail on what this advice should be, or how doctors should deliver it, according to a new review. And half of the advice topics included in guidelines were discordant with evidence from…
Comparative Assessment of the Different ACR/EULAR Remission Definitions for RA for Their Use as Clinical Trial End Points
Significant advances have been made in the treatment of RA over the past 20 years, and with the hope of developing even more effective therapeutics, achieving a very low level of disease activity, such as remission, is an important outcome to be examined. The ACR and EULAR have defined remission using Boolean- or index-based criteria. The researchers undertook this study to compare definitions of remission to inform choice of end points for future RA clinical trials and included in their comparison the remission criterion of a score of ≤2.8 on the Clinical Disease Activity Index…
Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA
Guselkumab Improves Active Psoriatic Arthritis New research has revealed that patients with active psoriatic arthritis (PsA) and ≥3% body area of plaque psoriasis benefit from treatment with a human monoclonal antibody known as guselkumab (GUS). GUS is specific for the p19 subunit of interleukin 23 (IL-23). Patients in the Phase 2 clinical trial experienced significant…
Benefits of Secukinumab in Ankylosing Spondylitis May Persist at 2 Years
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
Do RA Patients in Clinical Trials for Biologics Represent the Average?
It’s estimated that a majority of patients with rheumatoid arthritis (RA) have been exposed to biologic treatments. However, the randomized controlled trials demonstrating the safety and efficacy of these biologic agents have strict participant eligibility requirements. New research has examined the requirements of 30 trials for biologics and applied those standards to two large clinical cohorts. The result: A majority of these RA patients did not satisfy the criteria…
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