Top 3 Autoimmune Drugs

In 2018, most of the pharma activity for autoimmune conditions involved using existing FDA-approved medications for new indications or developing new drugs in existing drug classes. For example, Cosentyx (secukinumab) was first approved for plaque psoriasis and is now FDA approved for both psoriatic arthritis and ankylosing spondylitis.

“Drugs can oftentimes be used for different autoimmune diseases because one of the characteristics of these conditions, inflammation, can be triggered by the same autoimmune mechanism,” says Scott Zashin, MD, clinical professor of internal medicine in the rheumatology division at UT Southwestern Medical School at Dallas and a private practice rheumatologist at Presbyterian Hospitals of Dallas.

Here’s a look at three innovative drugs used to treat autoimmune conditions that made the news this year.

1. Xeljanz (tofacitinib)

In May 2012 FDA approved Pfizer’s tofacitinib citrate for moderately to severely active rheumatoid arthritis patients who either couldn’t tolerate or didn’t have success with methotrexate. In 2018, FDA approved it for adults with moderately to severely active ulcerative colitis.

“Tofacitinib is an option for patients who have failed other biological therapies; however, prior use of biologic therapy is not a requirement,” says Niket Sonpal, MD, FACP, DABIM, assistant professor of medicine at Touro College of Osteopathic Medicine in New York, New York.

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The drug is innovative because it blocks a newly-discovered receptor called Janus Kinase (JAK) 1-3. “When stimulated, this receptor can cause inflammation in patients and give symptoms of inflammatory bowel disease (IBD),” Sonpal says. By blocking the JAK 1-3 receptor, it shuts down an inflammatory pathway that in IBD patients causes inflammation and damage. Tofacitinib does this by affecting how cells in the body read and interpret DNA.

Tofacitinib is unique because most other IBD medications address a different inflammatory reaction caused by proteins called tumor necrosis factor (TNF) alpha. “Research shows that not all patients’ IBD symptoms are due to the same inflammatory reaction and by blocking a new receptor, new treatment options are available for IBD,” Sonpal says.

“Patients can take the drug by mouth and avoid going to the hospital for an intravenous infusion or injection-which many other IBD medications require,” he says. “This saves patients a lot of pain and hospital trips.”

2. Olumiant (baricitinib) 

Ely Lily and Company’s Olumiant 2 mg was FDA approved on June 1, 2018. Olumiant is effective in treating moderate-to-severe rheumatoid arthritis. It is intended as a third- or fourth-line therapy after patients have tried and failed to improve on older disease modifying therapies such as methotrexate and TNF inhibitors. “It is being investigated to treat other autoimmune conditions, such as psoriatic arthritis and lupus,” says Molly Magnano, MD, a rheumatologist at Sutter East Bay Medical Group in Berkeley, California.

Olumiant has several advantages over biological arthritis treatments. It is taken orally, rather than administered as an injection, and works quickly, Magnano says. In clinical trials, some patients experienced early symptom relief (at least 20% improvement) within one week.

“Olumiant is an effective treatment option for patients who have failed to improve on TNF inhibitors, which is important because this patient population has typically been considered the most difficult to treat,” she says. Its price is 60% lower than Humira, the leading TNF inhibitor, and 50% lower than tofacitinib, the first JAK inhibitor on the market for rheumatoid arthritis.

Olumiant, the second JAK inhibitor approved by FDA, works inside cells and results in dramatically reducing production of pro-inflammatory cytokines, which dampen rheumatic arthritis activity. In comparison, biological arthritis medications work outside cells to suppress inflammation.

3. Cosentyx (secukinumab)

Novartis’ Cosentyx was brought into the marketplace in 2015 as the first and only fully human interleukin 17A (IL-17A) antagonist approved for moderate to severe plaque psoriasis. Then, in 2016, FDA approved it for psoriatic arthritis and ankylosing spondylitis. It can also be used off-label to treat rheumatoid arthritis, says Joshua W. Gaborcik, PharmD, BCPS, specialty practice pharmacist-internal medicine, The Ohio State University Wexner Medical Center in Columbus. There are now other IL-17A antagonists on the market, but none are FDA-approved for all three conditions that Cosentyx treats.

IL-17A is a protein elevated in patients with plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. These diseases are caused by excess IL-17A and other proteins, which cause inflammation.

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Cosentyx, an injectable biologic, is a protein-based medication made from living cells. Biologics target specific parts of the immune system, rather than the entire immune system, says Evan Reidy, PharmD candidate 2019 at The Ohio State University Wexner Medical Center. Cosentyx is a human monoclonal antibody that inhibits IL-17A. By doing this, Cosentyx can decrease the body’s inflammatory response, which causes plaque psoriasis and psoriatic arthritis to occur.  

In 2018, Novartis received FDA approval for Cosentyx to help slow the progression of joint damage in psoriatic arthritis. This disease can lead to irreversible joint damage and disability caused by years of inflammation.

Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.