Authors of a study published in JAMA Network Open suggest that clinical treatment guidelines should be updated to include the initiation of biosimilars immediately after the failure of methotrexate for individuals with rheumatoid arthritis (RA).1
According to the Arthritis Foundation, methotrexate is one of the most commonly prescribed medications for arthritis, with an estimated 900,000 individuals taking the drug for RA, typically as a first-line treatment. The drug is an anti-inflammatory medication, which can reduce the pain and production of inflammatory proteins and is considered a disease-modifying antirheumatic drug (DMARD), which can slow progression of disease and joint damage.2 Approximately 20% to 50% of patients do not respond to methotrexate, and currently, there is no way to determine who will be a responder to the drug.2
In the most recent American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis, published in 2021, the organization strongly recommends using methotrexate over hydroxychloroquine or sulfasalazine for patients who are DMARD-naïve and have moderate-to-high disease activity and is conditionally recommended over leflunomide for the same patient population. The authors of the study added that combination therapy of methotrexate is frequented with biologic DMARDs if combination therapy with conventional synthetics DMARDs is unsuccessful.1,3
The authors noted that biologics pose a high financial burden for patients, adding that studies have showed that initiating biologics after failure of methotrexate is cost-effective and utilizing biosimilars would improve the cost-effectiveness of this strategy. Investigators aimed to examine the cost-effectiveness of the treatment sequence with biosimilars for infliximab (Remicade; Janssen Immunology) or adalimumab (Humira; AbbVie) compared to leflunomide (Arava; Sanofi), which is frequently used for patients with inadequate methotrexate response.1
In the study, the investigators developed a multistate Markov transition model to simulate the lifetime disease progression of 10,000 patients with RA and inadequate methotrexate response. The hypothetical patients started either leflunomide or biosimilar DMARD as the first-line treatment after failure of methotrexate. As the study progressed, patients either continued their treatment or discontinued and moved onto the next recommended treatment.1
Key Takeaways
- The study suggests that clinical treatment guidelines should be updated to include the initiation of biosimilars immediately after the failure of methotrexate for individuals with rheumatoid arthritis (RA).
- Approximately 20% to 50% of patients do not respond to methotrexate, and currently, there is no way to determine who will be a responder to the drug.
- Biologic DMARDs are a class of medications used to treat moderate to severe RA, but they can be expensive. Biosimilars are a type of biologic drug that is highly similar to an already approved biologic drug.
There were 25,099 patients included in the study, with a mean age of 56 years and 72.2% women. They found that the lifetime health cost and quality-adjusted life-years (QALYs) for leflunomide were $154,632 and 14.82, respectively. Further, for biosimilar infliximab and biosimilar adalimumab, they were $152,326 and 15.35 years and $145,419 and 15.55 years, respectively. Investigators concluded that the total health care cost for infliximab was $6907 greater and had a lower QALY compared with biosimilar adalimumab, but both had lower costs and greater QALYs compared with leflunomide.1
There were several limitations in the study, which included treatment efficacies being pulled from independent randomized-controlled trials and that the population was mainly naïve to biologic DMARDs or only had experience with 1 DMARD, according to the authors.1
Approximately 18 million individuals worldwide in 2019 were living with RA, according to the World Health Organization. Approximately 70% of those with RA are women and 55% are older than 55 years.4
References
1. Peng K, Chan SCW, Wang Y, et al. Cost-Effectiveness of Biosimilars vs Leflunomide in Patients With Rheumatoid Arthritis. JAMA Netw Open. 2024;7(6):e2418800. Published 2024 Jun 3. doi:10.1001/jamanetworkopen.2024.18800
2. Rath L. Understanding Methotrexate. Arthritis Foundation. March 18, 2024. Accessed July 9, 2024. https://www.arthritis.org/drug-guide/medication-topics/understanding-methotrexate
3. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-939. doi:10.1002/acr.24596
4. World Health Organization. Rheumatoid arthritis. June 28, 2023. Accessed July 9, 2024. https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis
