Documentation of off-label use of biologics in Rheumatoid Arthritis

Fürst, Daniel E.; Fleischman, Roy; Kalden, Joachim R.; Kavanaugh, Arthur; Sieper, Joachim; Mease, Philip; Smolen, Josef S.; Breedveld, Ferrie

doi:10.1136/annrheumdis-2013-consensusapp

Cited by 9 publications

(6 citation statements)

References 406 publications

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“…There was a surprising amount of off-label use of the high dose vaccine. While off-label use of medications is common particularly for oncology treatment, 18 antipsychotic medications 19 and the use of biologics to treat rheumatoid arthritis, 20 use of vaccines off-label is rare. We found only one recent study that reported the use of Tdap among elderly people.…”

Section: Discussionmentioning

confidence: 99%

On-label and off-label use of high-dose influenza vaccine in the United States, 2010–2012

McGrath

Brookhart

2015

Human Vaccines & Immunotherapeutics

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High-dose inactivated, influenza vaccine was licensed by the FDA in December 2009 for adults aged 65 y and older. The ACIP did not issue or state a preference for a specific vaccine in the elderly population. The extent of its on-label and off-label use is unknown. Using the MarketScan Commercial Claims and Encounters and the Medicare Supplemental database, we identified individuals who received the high-dose influenza vaccine or the standard, seasonal trivalent influenza vaccine between January 1, 2010 and December 31, 2012. For people aged ≥65 y, we used multivariable regression to assess the association between patient and provider level variables and high-dose influenza vaccine versus standard influenza vaccine. We characterized all off-label high-dose vaccine administered to people younger than 65 y of age, and investigated whether sicker patients were targeted for off-label use by examining the association between various comorbid conditions and receipt of the high-dose vaccine among adults aged 18-64. Among patients aged ≥65 y who received an influenza vaccine, 18.4% received the high-dose vaccine. Uptake was minimal in 2010, but 25% and 32% of influenza shots were the high-dose formulation in 2011 and 2012, respectively. Almost 27,000 seniors received a second high-dose vaccine with a median of 368 d (IQR: 350-387 days) between doses. Older age, family practice physicians, and having PPO insurance were positively associated with receiving high-dose vaccine. There were 36,624 off-label high-dose vaccines administered. Half of the patients receiving off-label doses were aged 50-64. Adults aged 18-64 y receiving high-dose vaccine were more likely to have chronic comorbidities than people receiving standard influenza vaccine; however, there was not one specific illness that seemed to be targeted by physicians. In the first 3 y since licensure, use of the high-dose vaccine among seniors has been limited. The safety of this vaccine should be monitored closely among 2 groups of people - seniors receiving repeat doses and people <65.

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Section: Discussionmentioning

confidence: 99%

On-label and off-label use of high-dose influenza vaccine in the United States, 2010–2012

McGrath

Brookhart

2015

Human Vaccines & Immunotherapeutics

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“…There are many instances where biologics have been successful in treating unlicensed inflammatory diseases [48]. Indeed some off-label uses are integral to disease management and recommended in guidelines.…”

Section: Off-label Use Of Biosimilarsmentioning

confidence: 99%

“…There is concern that if a drug can be used off-label, patients have less incentive to enrol in trials where they may receive a placebo. This may reduce opportunity to develop rigorous data and could explain why most off-label studies are anecdotal reports [48]. Most importantly, unregulated off-label prescribing can potentially expose patients to risky and ineffective treatments [61].…”

Section: Off-label Use Of Biosimilarsmentioning

confidence: 99%

Biosimilars: From Extrapolation into Off Label Use

Zhao

Nair

Moots

2018

CPD

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Biosimilars offer many potential opportunities in improving treatment access and increasing treatment options. The high cost associated with marketing approval means that many bio-originators may never become licenced for rarer inflammatory conditions, despite clinical efficacy. Biosimilars, with lower acquisition cost, may improve access for off-label use of biologics in the management of these patients. They may also provide opportunities to explore off-label treatment of conditions where biologic therapy is less established. However, this potential advantage must be balanced with the awareness that off-label prescribing can potentially expose patients to risky and ineffective treatments. Post-marketing surveillance is critical to developing long-term evidence to provide assurances on efficacy as well as safety.

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“…In real-world clinical settings, recommended treatment regimens are not always adhered to. This may be due to a variety of factors including physicians tailoring therapy to patients’ needs, for example, guided treatment withdrawal [ 7 , 8 ]; however, a number of studies have also reported suboptimal patient compliance and persistence with biologic therapy, which may reduce the clinical effectiveness of the prescribed treatment [ 9 – 11 ].…”

Section: Introductionmentioning

confidence: 99%

A Targeted Literature Review Examining Biologic Therapy Compliance and Persistence in Chronic Inflammatory Diseases to Identify the Associated Unmet Needs, Driving Factors, and Consequences

et al. 2018

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Chronic inflammatory diseases (CIDs) represent a substantial clinical and economic burden to patients, providers, payers and society overall. Biologics, such as tumor necrosis factor inhibitors (TNFi), have emerged as effective treatment options for patients with CIDs. However, the therapeutic potential of biologics is not always achieved in clinical practice, with results from studies examining the use of biologics in real-world settings suggesting lower levels of treatment effectiveness compared with clinical trial results. Using a targeted approach, this literature review demonstrates that compliance and persistence with biologic therapy is suboptimal and that this has implications for both clinical outcomes and treatment costs. The review identified a variety of predictors of treatment compliance and persistence, including increased age, female gender, presence of comorbidities, increased disease activity, longer disease duration, smoking, increased body mass index, higher biologic treatment dose, higher treatment cost and lower health-related quality-of-life scores. Patients often cited factors associated with medication delivery as a reason for non-compliance and non-persistence, and device-related improvements to treatment delivery were associated with higher rates of compliance and persistence. The articles identified in this review provide insights that have the potential to help guide the development of new solutions to improve disease management and optimize treatment regimens. This has the potential to benefit patients’ health by improving clinical outcomes and to reduce the burden to society by limiting the economic impact of patients’ disease.FundingUCB Pharma.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0759-0) contains supplementary material, which is available to authorized users.

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Documentation of off-label use of biologics in Rheumatoid Arthritis

Cited by 9 publications

References 406 publications

On-label and off-label use of high-dose influenza vaccine in the United States, 2010–2012

On-label and off-label use of high-dose influenza vaccine in the United States, 2010–2012

Biosimilars: From Extrapolation into Off Label Use

A Targeted Literature Review Examining Biologic Therapy Compliance and Persistence in Chronic Inflammatory Diseases to Identify the Associated Unmet Needs, Driving Factors, and Consequences

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