Can immunotherapy treat cancer in patients with autoimmune diseases?

Historically, cancer patients with autoimmune disease likes lupus, Type 1 diabetes and rheumatoid arthritis have been excluded from clinical trials studying immune checkpoint inhibitors. As a result, they haven’t been able to receive these immunotherapy drugs, which turn off the brakes of T cells to allow them to more effectively attack cancer cells.

“There are more than 80 different types of autoimmune diseases that affect 24 million people in the U.S.,” says Ecaterina Ileana Dumbrava, M.D., assistant professor of Investigational Cancer Therapeutics. The National Cancer Institute estimates there are almost 2 million new cancer diagnoses in the U.S. each year. Researchers are exploring how to expand immunotherapy to patients with autoimmune diseases who are facing a cancer diagnosis.

Immunotherapy may intensify autoimmune disease symptoms

Side effects of immune checkpoint inhibitors can be similar to symptoms of an autoimmune disease. “These drugs can cause inflammation throughout the body, so side effects involving organs can mimic autoimmune diseases like Crohn’s disease, autoimmune hepatitis or pneumonitis,” Dumbrava says.

In addition to the symptoms and side effects mirroring each other, treatment is similar, too. Steroids and immunosuppressants help to take down the inflammation and calm the immune system.

Although only about 5% of patients on immunotherapy experience these side effects, that number is thought to be higher in patients with autoimmune diseases. Also, it’s unknown if immunotherapy worsens the autoimmune disease.

While oncologists are well-versed in the medicine of cancer, Dumbrava stresses they not experts in autoimmune diseases. “With the revolution of immune checkpoints, oncologists are expected to be immunologists and rheumatologists and so forth, but we’re not,” she says. “So, for safety reasons, these patients have been excluded from immunotherapy clinical trials.”

Autoimmune diseases increase cancer risk

Despite the lack of research surrounding immunotherapy for patients with autoimmune diseases, there’s a great need for effective treatments for these patients with advanced cancer.

“Cancer cells occur in all of us, but an immune system that’s functioning normally is able to recognize the cancer cells and eliminate them,” says Dumbrava. Eventually, the cancer cells can evade the immune system and progress to a cancer diagnosis.

But the immune systems of patients with an autoimmune disease don’t behave the same way. “Their immune systems are wired differently,” Dumbrava says. It’s more difficult for the immune system to recognize those initial cancer cells, which puts patients with these chronic illnesses at a much higher risk for developing cancer.  

Determining safety of immunotherapy in patients with autoimmune diseases

Under the national leadership of Hussein Tawbi, M.D., Ph.D., a multicenter Phase I clinical trial is exploring the safety of nivolumab in patients with autoimmune diseases. Dumbrava serves as the principal investigator of the clinical trial at MD Anderson. The study is evaluating a flat dose of the immune checkpoint inhibitor nivolumab in patients with escalating levels of severity of autoimmune disease symptoms. Based on the symptom severity and the treatments that they’re receiving for the autoimmune disease, patients are classified as having mild, moderate and severe disease. Currently, the clinical trial is enrolling patients with mild autoimmune disease and will progress to enrolling patients with more severe disease in the future.

“The goal of the trial isn’t to determine the effectiveness of the immune checkpoint inhibitor – that’s been established. Instead, we’re looking at the safety of the drug in these patients,” Dumbrava says.

Despite previous hesitation with offering immunotherapy as a cancer treatment to patients with an autoimmune disease, Dumbrava is hopeful that this clinical trial will serve as a basis to include patients with autoimmune disease in future studies.

“This trial will help set a precedent for clinical trials on the horizon,” she says. “If you’re a patient with an autoimmune disease, know that this field is rapidly changing. Things that weren’t possible a few years ago are now saving lives. Don’t lose hope.” 

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