- New data of rheumatoid arthritis patients who participated in a HUMIRA (adalimumab) patient support program in select countries showed an association between the use of a patient support program and improvements in functional outcomes
MADRID, June 14, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today presented results from a 78-week post-marketing observational study showing that participation in an AbbVie patient support program (PSP) in the EU, Switzerland, Israel, Mexico, Puerto Rico and Australia was associated with statistically significant improvement in functional outcomes in patients with moderate to severe rheumatoid arthritis (RA) who initiated HUMIRA therapy.1,2 These data were presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid.
"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," said Dominik Hochli, Vice President, Global Medical Affairs at AbbVie.
The primary endpoint of the PASSION study was the percentage of study participants who achieved a minimal clinically important difference (MCID, or improvement of ≥ 0.22) in the Health Assessment Questionnaire Disability Index (HAQ-DI), a patient-reported questionnaire to measure RA function, at week 78, compared to baseline. Results showed that 72.1 percent of patients achieved the MCID in HAQ-DI at week 78 versus baseline (as observed).1,2
In further analysis using non-responder imputation (NRI), 42.8 percent of the patients achieved MCID in HAQ-DI at week 78 from baseline.1,2 PASSION also evaluated the potential impact of patient support program participation on functional outcomes in patients with moderate to severe RA compared to patients not participating in a support program. Results demonstrated that 48.1 percent of PSP participants achieved HAQ-DI MCID, compared to 37.8 percent of non-participants, at week 78, utilizing NRI (P<0.001).1,2
"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," said Professor Filip Van Den Bosch, Ghent University Hospital, primary investigator of the study. "Rheumatoid arthritis can be a debilitating disease that has a significant emotional and physical impact on one's life. The PASSION study results provide additional information on the 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. The incidence of adverse events was comparable to the known safety profile of adalimumab across approved indications.1,2 Study discontinuation rates were significantly lower among PSP participants compared to PSP non-users (25.5 percent vs 41.6 percent, P<0.001).1,2
About the PASSION Study
The observational PASSION study was designed to evaluate the effectiveness of HUMIRA on the course of RA treatment and patient treatment satisfaction in the context of patient support program utilization. The study enrolled patients in the European Union, Switzerland, Israel, Mexico, Puerto Rico, and Australia with moderate to severe RA (n=1,025) who had experienced an insufficient response to at least one disease-modifying anti-rheumatic drug (DMARD). Patients could have treatment with ≤1 prior biologic DMARD, but were naïve to HUMIRA treatment. Patients were prescribed HUMIRA according to the local product label with an option to utilize the PSP. Elements of the PSPs varied between countries, but all included a starter pack (medication and injection guides, and educational material such as patient booklet or DVD about RA), call center/hotline support, and nursing services.1,2 The primary endpoints were included in the prospective analysis. Comparisons between PSP and non-PSP users were part of a secondary analysis. Only observed confounders were accounted for, hence the findings of the study should be interpreted with the caution of unobserved confounding. Additionally, the study only collected data on study discontinuation rates and not on discontinuation of HUMIRA; therefore, no conclusions about drug adherence or persistence can be made from the current analysis. The estimated dropout rate was 30 percent.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic disease that imposes a substantial physical and economic burden on patients and society.3 RA was ranked in the top 15 percent of conditions causing global disability4 and affects approximately 23.7 million people worldwide.5
About HUMIRA in the European Union6
HUMIRA EU Therapeutic Indications
HUMIRA is approved for use in adults with moderate to severe active and progressive rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in adults and adolescents from 12 years of age with active moderate to severe hidradenitis suppurativa, pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indications.
Important EU Safety Information6
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.
Globally, prescribing information varies; refer to the individual country product label for complete information.
(See SmPC for full safety details)
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Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
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- Van den Bosch F, et al.  "Impact of Participation in the Adalimumab (HUMIRA) Patient Support Program on Functional and Clinical Outcomes among Patients with Rheumatoid Arthritis: PASSION Study." Poster presented at the Annual European Congress of Rheumatology (EULAR) 2017, June 14-17, 2017, Madrid.
- Van den Bosch, F., Ostor, A.J.K., Wassenberg, S. et al. Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study. Rheumatol Ther (2017). doi:10.1007/s40744-017-0061-7.
- Birnbaum H, et al. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. Vol. 26, No. 1, 2010, 77–90.
- Cross M et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-22
- World Health Organization. The Global Burden of Disease, 2004 Update. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Last accessed April 24, 2017.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated March 31, 2017. Accessed April 24, 2017.