Is Orencia (abatacept) contraindicated in patients with cancer?

From the Guidelines

Orencia (abatacept) is not absolutely contraindicated in all cancer patients, but caution is warranted, as evidenced by a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis 1. The decision to use Orencia in cancer patients should be made on a case-by-case basis, weighing potential benefits against risks. Orencia works by inhibiting T-cell activation, which may theoretically reduce immune surveillance against malignancies.

• Patients with a history of malignancy or active cancer should be carefully evaluated before starting Orencia therapy, considering the adjusted hazard ratio (aHR) for malignancies in patients on biologic DMARDs compared with patients on conventional synthetic DMARDs, which was found to be around 0.9 for most types of cancer 1.
• For patients with a remote history of cancer who are considered cured, Orencia may be an option after appropriate cancer screening, taking into account the aHR for solid cancer (excluding non-melanoma skin cancer) which was around 1.0 for Orencia (abatacept) compared to conventional synthetic DMARDs 1. The medication's immunosuppressive effects could potentially allow cancer cells to grow unchecked, though clinical data on this specific risk is limited.
• Patients with lymphomas or other hematological malignancies may be at higher risk of complications, with an aHR of around 1.0 for lymphoma in patients on tumor necrosis factor inhibitors (TNFi) compared to conventional synthetic DMARDs 1. Regular cancer screening is recommended for patients on Orencia, and any new symptoms should be promptly evaluated.
• If cancer develops during treatment, temporary or permanent discontinuation of Orencia may be necessary, depending on the cancer type and treatment plan, considering the potential risks and benefits of continued therapy 1.

From the FDA Drug Label

The possibility exists for drugs inhibiting T-cell activation, including ORENCIA, to affect host defenses against infections and malignancies since T cells mediate cellular immune responses. In clinical trials in patients with adult RA, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients [see Warnings and Precautions (5. 3) and Adverse Reactions (6.1)]. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood [see Adverse Reactions (6.1)].

Orencia is not directly contraindicated in cancer patients. However, the drug label warns that the possibility exists for ORENCIA to affect host defenses against infections and malignancies. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood.

• Key points to consider:
  • In clinical trials, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients.
  • The rate observed for lymphoma is approximately 3.5-fold higher than expected in an age- and gender-matched general population.
  • Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma.
  • There have been reports of malignancies, including skin cancer in patients receiving ORENCIA.
  • Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer 2 2.

From the Research

Orencia (Abatacept) in Cancer Patients

• Orencia, also known as abatacept, is a medication used to treat rheumatoid arthritis by modulating the immune system 3, 4, 5.
• The use of abatacept in cancer patients is a topic of interest, as it may affect the risk of malignancies or interact with cancer treatments 6, 7.

Malignancy Risk

• A 10-year international post-marketing study found no statistically significant increase in the risk of overall malignancies in patients treated with abatacept compared to those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or other biologic/targeted synthetic (b/ts)DMARDs 3.
• Another study found that the risk of malignancies with abatacept was not statistically significant versus other bDMARDs or versus csDMARDs 5.
• However, a comprehensive evaluation of randomized controlled trials and observational studies suggested a potential increase in non-melanoma skin cancer risk with abatacept use compared to csDMARDs, but no significant increase was observed compared to b/tsDMARDs 7.

Immune System Effects

• Chemotherapy can induce immune suppression, which can have significant implications for patient outcomes, including an increased risk of infections and a weakened anti-tumor immune response 6.
• Abatacept, as an immunomodulatory agent, may interact with chemotherapy-induced immune suppression, but the exact effects are not well understood and require further study 4, 5.

Use in Cancer Patients

• There is no clear contraindication for the use of orencia in cancer patients, but caution is advised due to the potential risks and interactions with cancer treatments 3, 5, 7.
• Patients with a history of cancer or those undergoing cancer treatment should be closely monitored for signs of malignancy or immune suppression when treated with abatacept 3, 6.