Impact of a Patient Support Program on time to discontinuation of adalimumab in Australian adult patients with immune-mediated inflammatory diseases-an observational study

PLoS One. 2024 Jun 13;19(6):e0300624. doi: 10.1371/journal.pone.0300624. eCollection 2024.

Abstract

This observational study evaluated the impact of a sponsor company-provided Patient Support Program (PSP) on discontinuation of adalimumab in adult Australian patients eligible for Pharmaceutical Benefit Scheme (PBS)-reimbursed adalimumab for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD), Ulcerative Colitis (UC), or Hidradenitis Suppurativa (HS). Patients initiating adalimumab between May 2018 and September 2019 were enrolled into two prospective cohorts based on their decision to opt for or decline the PSP (PSP or non-PSP cohorts). In addition, a historical, retrospective Non-PSP cohort was established from the Services Australia 10% PBS dataset by extracting data of patients initiating adalimumab prior to the introduction of adalimumab PSPs and based on adalimumab PBS listing dates (AS: April 2007 to March 2009; PsA/RA: January 2007 to December 2008; CD: January 2009 to December 2010; HS and UC indications not included). Follow-up for all cohorts was 12 months. The primary endpoint was the time to discontinuation, compared between the prospective PSP cohort and the prospective or retrospective Non-PSP cohort. Inverse probability of treatment weighting was used to balance the cohorts. A Cox proportional hazards model indicated no difference in time to discontinuation between the prospective PSP (n = 162) and non-PSP (n = 65) cohorts (HR [95% CI] = 1.256 [0.616-2.563], p = 0.5304). The 12-month adalimumab persistence rates (95% CI) were 78% (69%, 84%) and 82% (67%, 90%), respectively. In contrast, discontinuation was less likely in the prospective PSP (n = 151) compared with the retrospective non-PSP (n = 297) cohort (HR [95% CI] = 0.44 [0.28-0.68], p<0.001). The 12-month persistence rates (95% CI) were 81% (76%, 90%) and 61% (56%, 67%), respectively. Overall, this study suggests that optimal adalimumab persistence can be achieved with either a structured PSP or healthcare support from other sources, but this was not the case more than a decade ago.

Publication types

  • Observational Study

MeSH terms

  • Adalimumab* / administration & dosage
  • Adalimumab* / therapeutic use
  • Adult
  • Aged
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / therapeutic use
  • Australia
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Retrospective Studies
  • Spondylitis, Ankylosing / drug therapy
  • Withholding Treatment

Substances

  • Adalimumab
  • Antirheumatic Agents

Grants and funding

AbbVie sponsored the study; contributed to the design; participated in the collection, analysis, and interpretation of data; in writing, reviewing, and approval of the final version of the manuscript. No honoraria or payments were made for authorship. MC and SS are employees of AbbVie. AW is an employee of AbbVie and owns AbbVie stock. This does not alter MS, SS and AW adherence to PLOS ONE policies on sharing data and materials. GJ declares no conflicts of interest in this work. JB reports that he has received speaking fees and consultancy fees from Abbvie. MHK is a former employee of Prospection Pty Ltd, the company contracted by AbbVie to conducted by AbbVie to undertake the analyses using PBS 10% sample data according to the protocol. EY is a former employee of Southern Star Research Pty Ltd, the company contracted by AbbVie to conduct and analyze the prospective component of the study. P.F-P has served on advisory boards for: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squib, Eli Lilly, Jansssen, L'Oreal, LEO Pharma, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and UCB; has given educational lecture for AbbVie, Amgen,Bristol Myers Squib, Eli Lilly, Jansssen, L'Oreal, LEO Pharma, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and UCB Pharma and Zeullig Pharma; has conducted clinical trials for AbbVie, Akaal, Akesobio, Amgen, Arena, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, CSL, Eisai, Eli Lilly, Galderma, Incyte, Janssen, Jiangsu Hengrui, KoBioLabs, Kyowa Hakko Kirin, Merck, Merck Sharp & Dohme, miRagen, Moderna, Nektar, Novartis, OncoSec, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma… AJO has reported Consultant +/- Advisory +/- Undertaken clinical trials for AbbVie, BMS, Janssen, Lilly, Novartis & Pfizer.