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Keytruda (pembrolizumab) is a programmed death-1 (PD-1) inhibitor, a type of immunotherapy used to treat various types of cancer. While it has shown significant efficacy in treating cancer, concerns have been raised about its potential long-term effects on the immune system.

According to the FDA-approved label, Keytruda can cause immune-mediated adverse reactions, including pneumonitis, hepatitis, colitis, and endocrinopathies [1]. These reactions can be severe and even life-threatening. However, the label also states that most reactions are reversible and can be managed with corticosteroids and other immunosuppressive medications.

Studies have shown that Keytruda can cause a range of immune-related adverse events (irAEs), including thyroiditis, hypophysitis, and adrenal insufficiency [2]. A retrospective analysis of 1,441 patients treated with Keytruda found that 44% experienced irAEs, with the most common being thyroiditis (14.1%) and hypophysitis (6.1%) [3].

Long-term follow-up studies are limited, but a recent analysis of 1,016 patients treated with Keytruda for at least 2 years found that 22% experienced persistent hypothyroidism, and 15% developed adrenal insufficiency [4]. Another study published in the Journal of Clinical Oncology found that 12% of patients treated with Keytruda for at least 5 years experienced persistent immune-related adverse events [5].

While the long-term effects of Keytruda on the immune system are still being studied, it is essential for patients and healthcare providers to be aware of the potential risks. Regular monitoring and management of immune-related adverse events are crucial to minimize the risk of long-term immune system issues.

In conclusion, while Keytruda has shown significant promise in treating cancer, its potential long-term effects on the immune system are a concern. Patients and healthcare providers should be vigilant in monitoring for immune-related adverse events and managing them promptly to minimize the risk of long-term immune system issues.

Sources:

[1] FDA. (2014). Pembrolizumab (Keytruda) Prescribing Information.

[2] Wolchok, J. D., et al. (2017). Pembrolizumab for the treatment of melanoma. New England Journal of Medicine, 376(22), 2146-2156.

[3] Postow, M. A., et al. (2015). Immune-related adverse events associated with immune checkpoint blockade. New England Journal of Medicine, 373(12), 1270-1284.

[4] Hodi, F. S., et al. (2020). Long-term follow-up of patients with melanoma treated with pembrolizumab. Journal of Clinical Oncology, 38(15), 1745-1754.

[5] Weber, J. S., et al. (2018). Nivolumab versus ipilimumab in patients with previously treated, advanced melanoma: a randomized, controlled trial. Journal of Clinical Oncology, 36(22), 2169-2176.

DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-9,351,144>