Lupus Expert Calls for Better Research, Outcomes of Clinical Trials

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July 12, 2016 • By

The Rheumatologist

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

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Why Rheumatologist–Pulmonologist Collaboration Is Essential

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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

HIV Infection: What Rheumatologists Need to Know

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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.

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Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults

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Himal Lal, M.D et al.

N Engl J Med 2015; 372:2087-2096 May 28, 2015DOI: 10.1056/NEJMoa1501184

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.)

Biologic monotherapy in the treatment of rheumatoid arthritis

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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

Osteoarthritis: management Clinical Pharmacist, 24 APR 2015By Tina Hawkins , Andrew Barr

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Citation: Clinical PharmacistURI: 20068309

A wide range of drug classes are used in treating osteoarthritis (OA). Pharmacological therapies are adjuncts in the management of OA but there are no specific prescribing patterns because of the heterogenous nature of OA.

Joint replacement surgery (pictured) should be considered when a patient with OA suffers persistent debilitating symptoms despite treatment

Source: Luca DiCecco / Alamy

Joint replacement surgery (pictured) should be considered when a patient with osteoarthritis suffers persistent debilitating symptoms despite treatment

Summary

There are no pharmacological treatments that are known to prevent or cure osteoarthritis. Current management is directed at providing symptomatic relief. Pharmacological treatments are adjuncts that offer at best moderate symptom relief and the key to management is a combination of this with lifestyle change. Exercise regimens should include local muscle strengthening (e.g. quadriceps muscle exercises for knee OA) combined with general aerobic fitness. Ideally, patients should have an individualised exercise programme they can perform daily.

International guidelines recommend the use of topical non-steroidal anti-inflammatory drugs (NSAIDs) and/or paracetamol as the first-line treatment of choice. If these are inadequate, the patient should stop their current therapy and use an oral NSAID (either a non-selective or cyclo-oxygenase 2 inhibitor). Patients using oral NSAIDs should also be prescribed a proton pump inhibitor.

The use of opioids is supported in current guidance from the National Institute for Health and Care Excellence, but no reference is made to individual drugs. Opioid analgesics may be indicated for some patients with unacceptable pain despite treatment with oral paracetamol or topical NSAIDs when oral NSAIDs or COX 2 inhibitors are contraindicated.

Osteoarthritis (OA) has a broad range of presentations and therefore its potential impact on a patient’s personal life and employment can vary significantly. The management of OA must therefore be personalised and may include both pharmacological and non-pharmacological interventions. This approach has been shown to provide patients with better pain and functional outcomes[1].

The pain and disability associated with OA can have a significant impact on mood and may impair participation in both work and recreational activities. Patients should be educated about their OA and be provided with a tailored self-management plan to maintain physical function and fitness, reduce pain and prevent further deterioration.

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