Patient Support Program May Decrease Rates of Adalimumab Discontinuation Among Patients with IMIDs

Graeme Jones, MD, MBBS

Credit: University of Tasmania

An observational study revealed a Patient Support Program (PSP) could be a beneficial tool for disease management among patients with immune-mediated inflammatory diseases (IMIDs) and decrease the risk of adalimumab discontinuation, according to research published in PLoS One.¹ However, this was only observed in groups where persistence rates were suboptimal, due in part to a lack of patient education and support services.

“Patient education and support in the form of Patient Support Programs are postulated to positively influence biologic disease-modifying antirheumatic drug (bDMARD) persistence, and hence patients’ outcomes, through optimization of factors including correct timing of doses, reduced missed doses, optimal self-injection technique, lifestyle education and support, and education on the medicine,” wrote a team of investigators led by Graeme Jones, MD, MBBS, rheumatologist and professor at the Menzies Institute for Medical Research, University of Tasmania, Australia.¹

However, there have been mixed evidence regarding the benefits of PSPs. Although some research has suggested PSPs improve medication persistence and adherence, other studies report no significant benefits. Investigators believe the ultimate benefits may therefore be influenced by a variety of factors including dosing regimen, the specific medical condition, drug class, accessibility, PSP specific offerings, and the level of patient support provided by their clinicians.^2,3

Australian patients with IMIDs, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa initiating adalimumab between May 2018 and September 2019 were recruited into 2 prospective cohorts based on patient decision to opt into the PSP or decline the PSP. Additionally, a retrospective non-PSP group was analyzed from the Services Australia 10% Pharmaceutical Benefit Scheme (PBS) dataset using information from patients starting adalimumab prior to the introduction of PSPs.¹

Participants were observed for 12 months. The primary endpoint was the time to adalimumab discontinuation among the PSP cohort and either the prospective non-PSP cohort or retrospective non-PSP cohort.¹

The PSP included a Welcome kit, which contained a patient booklet, cold pack, sharps bin, QR codes to injection videos, step-by-step injection guides, and a magnet injection reminder, as well as access to an online resource to learn more about the drug, receive safety information, order replacement sharps bins, and request a nurse injection training session and/or request a health coach. These patients also received information on mental health resources, patient organizations, and sharps disposal.¹

In total, 193 patients were placed in the PSP cohort and 87 were placed in the non-PSP cohort.¹

Results of the Cox proportional hazards model showed no difference in time to discontinuation between the prospective PSP and non-PSP cohorts (hazard ratio [HR] [95% confidence interval (CI)] = 1.256 [.616 – 2.563], P = .5304). At month 12, adalimumab persistence rates were 78% in the PSP group compared with 82% in the prospective non-PSP group.¹

However, discontinuation was less likely in the prospective PSP group (n = 151) compared with the retrospective non-PSP group (n = 297) (HR [95% CI] = .44 [.28 – .68], P <.001). Among these cohorts, the 12-month persistence rates were 81% in the PSP group and 61% in the non-PSP PBS 10% sample.¹

Gender and age were also factors for treatment discontinuation, with results showing men and younger patients (aged 18 – 34 years) were less likely to discontinue adalimumab compared with older patients (aged ≥ 65 years).¹

“Overall, this demonstrates that optimal adalimumab persistence can be achieved with either structured PSP or healthcare support from other sources,” investigators concluded.¹ “The findings may aid in identifying patients most likely to benefit from participation in a PSP.”

References

1. ^{Jones G, Calao M, Begun J, et al. 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;19(6):e0300624. Published 2024 Jun 13. doi:10.1371/journal.pone.0300624}
2. ^{Brixner D, Rubin DT, Mease P, Mittal M, Liu H, Davis M, et al. Patient support program increased medication adherence with lower total health care costs despite increased drug spending. Journal of Managed Care & Specialty Pharmacy. 2019;25(7):770–9. pmid:31081461.}
3. ^{Moss AC, Chaudhary N, Tukey M, Junior J, Cury D, Falchuk KR, et al. Impact of a patient-support program on mesalamine adherence in patients with ulcerative colitis—A prospective study. Journal of Crohn’s and Colitis. 2010;4(2):171–5. pmid:21122501.}