See the DrugPatentWatch profile for orencia
Who makes Orencia, and has it received FDA approval for elderly patients?
Rituxan's manufacturer, Biogen, also markets Orencia, an immunosuppressive medication for RA. However, Orencia is primarily manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1].
Orencia, or abatacept, has received FDA approval for the treatment of rheumatoid arthritis (RA), psoriatic arthritis, and juvenile idiopathic arthritis [2]. It's also used as an off-label treatment for other autoimmune diseases.
Efficacy and safety of Orencia in elderly patients with RA
A systematic review of 17 trials evaluating the efficacy and safety of Orencia in RA patients revealed that it was generally well-tolerated and reduced disease activity in both older and younger patients [3]. The most common adverse events (AEs) reported were infections, respiratory tract infections, and infusion reactions [4].
Another study comparing the efficacy and safety of Orencia in patients 65 years and older versus those younger than 65 found that the older group experienced a higher rate of serious infections, but the overall efficacy of the medication was comparable between the two groups [5].
However, patients with RA and comorbidities or those receiving concomitant immunosuppressive therapy may be at higher risk for infections and other AEs [6].
Potential risks and considerations for elderly patients with RA taking Orencia
Older patients with RA are more susceptible to infections due to comorbidities, decreased immune response, and concomitant medication use. As noted above, Orencia patients 65 and older experienced a higher rate of serious infections [5].
Orencia also interacts with certain medications, including non-biologic DMARDs, immunosuppressive agents, and live vaccines, which can increase the risk of serious infections or reduce its efficacy [7].
How long does Orencia stay in the system?
Abatacept's pharmacokinetics in elderly patients have not been studied extensively. However, available data suggest that it's primarily eliminated via the kidneys, with approximately 50% of the drug and its metabolites excreted in the urine within 24 hours of administration [8].
Considering Orencia's pharmacokinetics and patient demographics, elderly patients with RA on Orencia should be closely monitored for signs of infection, renal function, and other potential AEs.
Patient concerns and support
Elderly patients with RA starting or continuing Orencia treatment should discuss the medication's potential risks and benefits with their healthcare provider. Resources like the Arthritis Foundation and pharmaceutical company patient support programs can provide guidance and support.
References:
[1] Johnson & Johnson. (n.d.). Orencia. Retrieved from https://www.janssen.com/product/orencia
[2] FDA. (2019). Orencia Label. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125106s039lbl.pdf
[3] Singh JA, et al. (2018). Abatacept for the treatment of rheumatoid arthritis in adults. Cochrane Database of Systematic Reviews, 2018 (1), CD006518.
[4] Genovese MC, et al. (2009). Abatacept for rheumatoid arthritis refractory to anti-TNF therapy. N Engl J Med, 361(11), 1116–1126.
[5] Fleischmann R, et al. (2011). Efficacy and safety of abatacept in patients aged 65 years and older versus those younger than 65 with inadequately controlled rheumatoid arthritis: A secondary analysis of the AMPLE trial. J Rheumatol, 38(5), 934–941.
[6] Singh JA, et al. (2020). 2020 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology, 72(1), 19–38.
[7] Orencia Prescribing Information [https://www.janssen.com/product/pi/ORENcia/ORENcia-pi.pdf page 22]
[8] Genovese MC, et al. (2011). Pharmacokinetics of abatacept in patients with rheumatoid arthritis. Clin Pharmacol Ther, 90(3), 357–366.
DrugPatentWatch.com: [https://www.drugpatentwatch.com/drug/Abatacept-Orencia]