A recently approved Phase III clinical trial being conducted at Temple University Hospital is investigating whether a new, investigational drug for lupus is more effective than medications currently in use. In early phases, the drug, anifrolumab, reduced symptoms in more than half of patients after a year. Patients on the drug also had a decreased need for corticosteroids to treat inflammation that is common in lupus.
“The data from the Phase II trial was so promising that the FDA has granted fast-track approval for this new medication,” says Roberto Caricchio, MD, the trial’s primary investigator at Temple and Director of the Temple Lupus Clinic at the Lewis Katz School of Medicine at Temple University. “That’s excellent news because currently there are only four other drugs that have been approved to treat lupus, and only one of those was approved in the past 50 years. It is hoped that this treatment will help patients. However, this cannot be guaranteed.”
Temple is the only hospital in the Philadelphia region serving as an investigational site for the new drug, developed by AstraZeneca.
A diverse and complicated autoimmune disease, lupus affects approximately 1.5 million Americans, and more than 16,000 new cases are reported every year. Many of the medications used to manage lupus symptoms – such as joint and muscle pain, fever, rashes, and fatigue – are actually prescribed off-label.
“That means these drugs haven’t been tested with rigorous clinical trials in patients with lupus, which could lead to undesirable side effects, especially when used long-term,” Dr. Caricchio says. “Lupus causes such a spectrum of manifestations ranging from mild to life-threatening and everything in between, which is why it’s difficult to develop medications to treat it and to determine whether patients are responding to those medications.”
Intended for patients with moderate to severe systemic lupus erythematosus, anifrolumab targets interferon type-1, a protein involved in inflammation that has been known for decades to be important in the pathogenesis of the disease.
“Interferon type-1 is a molecule called a cytokine, which activates a variety of immune cells in lupus and triggers flares,” Dr. Caricchio explains. “Each immune cell has a ‘lock’ (receptor) that is opened by the ‘key’ interferon type-1. Once the lock is open the cell activates and so does the lupus. Previous lupus medications tried to block the interferon type-1 cytokine, but anifrolumab directly blocks the receptor (the lock) on the cell instead, making it more effective.”
Temple investigators are seeking 10 to 20 study participants between the ages of 18 and 70 with moderate to severe lupus who are currently taking prescription medication to treat lupus. The clinical trial will last a year and a half and requires 16 total visits. All study-related care will be provided at no cost, and patients will continue to take their current lupus medications in addition to receiving the new medication intravenously once a month. Patients will also complete regular questionnaires from home and submit them electronically.
For more information about this or other clinical research trials at the Temple Lupus Clinic, email firstname.lastname@example.org or call 215-707-4479.
Editor’s Note: Neither Dr. Caricchio nor any member of his immediate family has financial interest in AstraZeneca.
Date Published: Tuesday, September 13, 2016
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