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Abstract Number: 2232

Above-Label Dosing with Biologics in Treatment-NaïVe and Treatment-Experienced Patients with Moderate-to-Severe Psoriatic Arthritis

Sergio Schwartzman1, Yunfeng Li2, Huanxue Zhou3, Vivian Herrera2 and Jacqueline B. Palmer2, 1Hospital for Special Surgery, New York, NY, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, 3KMK Consulting Inc, East Hanover, NJ

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: anti-TNF therapy, Biologic agents, prescribing trends, psoriatic arthritis and treatment

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Session Information

Date: Tuesday, November 15, 2016

Title: Health Services Research - Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Title: Above-Label Dosing with Biologics in Treatment-Naïve and Treatment-Experienced Patients with Moderate-to-Severe Psoriatic Arthritis Authors: S. Schwartzman*1, Y. Li2, H. Zhou3, V. Herrera2, J. Palmer2 Affiliations: 1Hospital for Special Surgery, New York, NY, US; 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, US; 3KMK Consulting Inc., Morristown, NJ, US

Background/Purpose: Moderate-to-severe psoriatic arthritis (PsA) patients may be treated with biologics. Limited evidence is available about biologic utilization patterns outside approved doses. This study described the extent of dosing for etanercept (ETA), adalimumab (ADA), certolizumab (CER), golimumab (GOL), and ustekinumab (UST) among moderate-to-severe PsA patients who were biologic naïve versus (vs) previously treated with biologics.

Methods: Adult PsA patients in the MarketScan® claims database were identified between 01/01/2011‒12/31/2013 (identification period), with a 1-year follow-up and 3-month look-forward period (post-index period) ending 3/31/2015. Patients included had ≥1 PsA diagnosis using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 696.0 and ≥1 pharmacy claim for ETA, ADA, CER, GOL, or UST during the identification period. Patients were considered treatment-naive if they had no prior biologic use or treatment-experienced if they had previous use of any biologic in the 6 months before the index date. Excluded patients had any other autoimmune disease indicated for treatment with biologics of interest. Intravenous biologic therapy was not evaluated due to lack of available data in MarketScan databases. Mean days of above-label use (daily maintenance dose ≥10% higher than indication), below-label use (daily maintenance dose ≤10% less than indication), and on-label use (daily maintenance dose ±10% than indication) per patient were described and stratified by treatment-naïve vs treatment-experienced patients.  

Results: This study identified 4245 PsA patients receiving biologic therapy: ETA (n=2342), ADA (n=1788), and GOL (n=115), respectively. Patients on CER (n=0) or UST (n=14) were not included due to small sample size and because both agents were only approved for PsA in late 2013. The majority of patients were male (~50-60%), with a mean age of ~50 years of age, and from the South of the United States. Across all three biologic patient cohorts examined, the majority of PsA patients were treatment-experienced, with ETA showing the highest proportion of patients with prior biologic use (67%), followed by GOL (57%) and ADA (56%) (Table 1). Treatment-experienced patients on ADA had greater mean days of above-label use compared to those naive to treatment (47 vs 19 days); however, treatment-experienced patients on ETA and GOL had fewer days of above-label use on average compared to naïve counterparts (ETA: 16 vs 20 days; GOL: 9 vs 16 days). Table 1. Mean days of above-label, on-label, and below-label use per patient per year

 

ETA (n=2342)

ADA (n=1788)

GOL (n=115)

Total number of patients, n (%)

 

 

 

  Naïve

783 (33.4)

791 (44.2)

49 (42.6)

  Experienced

1559 (66.6)

997 (55.8)

66 (57.4)

Total days on treatment, n

 

 

 

  Naïve

299

306

304

  Experienced

291

299

309

Average days of above-label use, mean (SD)

 

 

 

  Naïve

20 (61)

19 (54)

16 (67)

  Experienced

16 (60)

47 (107)

9 (49)

Average days of on-label use, mean (SD)

 

 

 

  Naïve

277 (99)

286 (86)

288 (77)

  Experienced

271 (101)

251 (123)

300 (77)

Average days of below-label use, mean (SD)

 

 

 

  Naïve

3 (24)

1 (14)

0 (0)

  Experienced

4 (33)

0 (9)

0 (0)

Conclusion: Above-label use was observed in PsA patients treated with ETA, ADA, and GOL; Prior biologic use seems to be a factor in above-label use of ADA versus other biologic cohorts.       


Disclosure: S. Schwartzman, Speaker for: Genentech, Janssen, AbbVie, Crescendo, Pfizer, Hospira, and Novartis, 8,National Psoriasis Foundation: Board Member, 6,Consultant for: Genentech, Janssen, AbbVie, Pfizer, Epirus, Hospira, Novartis, Regeneron, and Crescendo, 5,Scientific Advisory Board: Crescendo - Bioscience, 9; Y. Li, Novartis Pharmaceuticals Corporation, 3; H. Zhou, KMK Consulting Inc., 3; V. Herrera, Novartis Pharmaceuticals Corporation, 3,Novartis Pharmaceuticals Corporation, 1; J. B. Palmer, Novartis Pharmaceuticals Corporation, 3.

To cite this abstract in AMA style:

Schwartzman S, Li Y, Zhou H, Herrera V, Palmer JB. Above-Label Dosing with Biologics in Treatment-NaïVe and Treatment-Experienced Patients with Moderate-to-Severe Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/above-label-dosing-with-biologics-in-treatment-naive-and-treatment-experienced-patients-with-moderate-to-severe-psoriatic-arthritis/. Accessed .
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