Real-world data from a 78-week postmarketing observational study showed an association between participation in an AbbVie patient support program (PSP) and a statistically significant improvement in functional outcomes in patients with moderate-to-severe rheumatoid arthritis (RA) treated with adalimumab (Humira).
 
The PASSION study was designed to evaluate the efficacy of treatment with adalimumab and patient satisfaction regarding PSP utilization, according to a press release.
 
For the study, investigators enrolled 1025 patients with moderate-to-severe RA who had an insufficient response to at least 1 disease-modifying antirheumatic drug (DMARD) into PSPs in the EU, Switzerland, Israel, Mexico, Puerto Rico, and Australia.
 
Although the elements of PSPs varied between the countries, they all included a call center/hotline support, nursing services, and a starter pack consisting of medication and injection guides, as well as educational material about RA, such as patient booklet or DVD.
 
The primary endpoint was the percentage of participants who achieved a minimal clinically important difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) and a patient-reported questionnaire to measure RA function at week 78 compared with baseline.
 
The endpoints were included in the prospective analysis, and comparisons between PSP and non-PSP users were part of a secondary analysis, according to a release.
 
The results of the study showed that 72.1% of patients achieved the MCID in HAQ-DI at week 78 compared with baseline.
 
Using a non-responder imputation for further analysis, the investigators found that 42.8% of patients achieved MCID in HAQ-DI at week 78 from baseline.
 
The investigators also evaluated the potential impact of PSP participation on function outcomes in patients with RA compared with patients who did not participate in a PSP, according to the release. The results showed that 48.1% of PSP participants achieved HAQ-DI MCID compared with 37.8% of non-participants at week 78.
 
“We have the ability to treat rheumatoid arthritis with therapies that have had a positive clinical impact, but it is also important to further understand what patients living with this disease need beyond medicine, including access to patient support programs,” primary study investigator Professor Filip Van Den Bosch, said in a release. “Rheumatoid arthritis can be a debilitating disease that has a significant emotional and physical impact of a patient support program in helping patients better manage their disease and improve functional outcomes.”
 
No new safety signals were identified with adalimumab treatment, according to the release. Adverse events were comparable to the known safety profile across approved indications. Furthermore, study discontinuation rates were significantly lower among PSP participants (25.5%) compared with PSP non-users (41.6%).
 
“AbbVie is committed to helping patients living with immune-mediated inflammatory diseases like RA improve how they manage their disease, which includes understanding the factors that may contribute to care management,” Dominik Hochli, vice president of Global Medical Affairs at AbbVie, said in a release.
 
Rheumatoid arthritis is ranked in the top 15% of conditions causing global disability. It affects approximately 23.7 million individuals worldwide.
 
The data will be presented at the Annual European Congress of Rheumatology meeting in Madrid in June.