Monday, 18 Jun 2018

You are here

Above-Label Dosing and Noncompliance with Biologics in Psoriatic Arthritis

In this era of treat-to-target or remission targeted therapeutics, the options in managing nonresponders are many; often including off-label doses (i.e., dose escalations or reduction, increasing frequency; interrupted treatment). The use of above-label dosing, and its' effect on drug costs, has seldom been studied. 

Schwartzman and colleagues have studied biologic utilization in psoriatic arthritis (PsA), and the economic impact of increased doses, specifically looking at costs associated with above-label dosing and noncompliance with biologics in PsA.

Using MarketScan claims data they analyzed the first biologic claim with a 1-year follow-up period. The duration of use was stratified into three groups: <30, 30–179, and ≥180 days and defined above-label dosing as >10% of the labeled dose. They analyzed 4245 PsA patients treated with common biolgics (etanercept; n = 2342 ; adalimumab 1788, golimumab 115) between 2011 - 2013.

Above-label dosing for  <30 days was common and seen in 85% of adalimumab, 90.4% of etanercept, and 95.7% of golimumab patients. Longer term (≥180 days) was less common  (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab).

The mean number of days of on-label use ranged from 267 (adalimumab) to 295 (golimumab).

The mean number of days of above-label use was lowest with golimumab (12 days) and highest with adalimumab (35 days). Etanercept days of above-label use was 17  days.

Noncompliance could be inferred by no-use or below-label use days.  Below-label use was onlyreported for etanercept (4days) and adalimumab (1 day). No use was significantly higher for etanercept (71 days), compared to adalimumab (63 days), and golimumab (59 days).

All-cause total healthcare costs rose substantially with above-label use (p < 0.05).

These analyses suggest noncompliance with biologics is very common and that above-label use of anti-TNF biologics not only occurs, but is associated with significantly increased healthcare costs.

The clinical consequences or associations of these off-label dosing practices could not be studied in this claims dataset.

Dr. Schwartman collaborated with Novartis to perform these studies.

 

Disclosures: 
The author has received research/grant financial support on this subject
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Increased Risk of Infection in Psoriasis and Psoriatic Arthritis

As we gather more knowledge about psoriatic arthritis ( PsA) and psoriasis (PSO) over time, and achieve better outcomes with new therapies, more questions arise about quality of life, survival  and comorbidities in PsA and PSO. Similarly to RA, we learned about increased risk of CVD and malignancy. With more data compiled in cohorts it is possible now to ask the same questions as we asked in RA.

Cardiovascular Risk Factors in Psoriasis, PsA and Seronegative SpA

Not a surprise to anyone anymore, increased risk of cardiovascular disease poses a danger of significant morbidity and mortality in patients underlying inflammatory arthritides. A single center cross -sectional observational study was designed to conduct deeper analysis of Cardiovascular Risk Factors (CVRF) in patients with PsA, PSO without arthritis and SpA without PSO (THU 0297).

MRI Imaging for Sacroiliitis Requires Bone Marrow Edema for Reliability

de Winter and colleagues from the Netherlands have reported on magnetic resonance imaging of the sacroiliac joints of healthy subjects, patients with axial spondyloarthritis, runners and those with chronic back pain, and found a high incidence of sacroiliitis in many, but that deep bone marrow edema was most specific for those with axial SpA.

Cancer Risk Raised in Psoriatic Arthritis

Patients with psoriatic arthritis (PsA) were at increased risks for malignancy, and possibly more so if they were treated with conventional disease-modifying antirheumatic drugs (DMARDs), a meta-analysis found.

In nine cohort studies that included more than 43,000 PsA patients, the pooled relative risk for overall malignancy was 1.29 (95% CI 1.04-1.60) compared with the general population, according to Yunyun Fei, MD, and colleagues from Peking Union Medical College in Beijing.

Trends in Psoriatic Arthritis Treatment 2004-2015

Lee and colleagues from Brigham and Women's Hospital have analyzed the last decade of disease‐modifying antirheumatic drugs (DMARDs) use in patients with psoriatic arthritis (PsA) and found nearly 40% were treated with a bDMARD, along with a decreasing trend in complete DMARD discontinuations.