Johns Hopkins Receives $13.4 million to Study Early MS Treatment Options

Scientists from Johns Hopkins University have been awarded $13.4 million to conduct research that one day might help newly diagnosed patients with multiple sclerosis (MS) find a clearer picture of which treatment option is best for them.

The funding is coming from the Patient-Centered Outcomes Research Institute, an independent nonprofit agency funded by the government and created by the Affordable Care Act. The decision to fund this MS research came as a result of a stakeholder workshops involving patients, advocacy groups, physicians, government agencies, and insurers.

Joe Selby, MD, MPH, the executive director of PCORI, told MD Magazine that the money is intended to help elucidate the options for MS patients at what can be a confusing time.

“People living with multiple sclerosis (MS) and those who care for them face many decisions about managing the often unpredictable condition,” he said. “There are currently over a dozen approved MS-modifying drugs that may be prescribed — with different side effects and few data that directly compare their effectiveness.”

The Johns Hopkins study will focus on comparing treatments that became available in the mid-1990s to MS-control strategies based on newer medications. Those newer medications appear to be more likely to reduce early episodic symptoms of MS, but it’s not yet known how they perform comparatively over the long-term. The newer treatments can also come with significant risks.

Scott Newsome, DO — who will lead the JHU research along with Ellen Mowry, MD, MCR — said the risks of the new treatments can vary.

“Some of the risks include opportunistic infections, secondary autoimmunity, and malignancy,” Newsome told MD Magazine. “Moreover there are unknown risks with newer therapies, especially those that are deemed higher efficacy.”

Newsome and Mowry are part of a team of investigators at JHU’s Precision Medicine Center of Excellence for Multiple Sclerosis.

The study will follow patients for at least 3.5 years, and possibly as long as 5 years. He hopes to continue following patients after that, though such extended tracking would require additional funding, Newsome said.

During the stakeholder process, Selby said patients also raised questions about telerehabilitation and whether the approach is equal to in-clinic visits when it comes to improving fatigue, endurance, and quality of life.

Telemedicine represents another area where patients are currently inhibited in their abilities to make informed choices, Selby said.

“To choose which treatment options might work best in a specific situation, patients and their clinicians need information about the comparative benefits and harms of available therapies, but such data are often in short supply,” Selby said.

Many of the new treatments come with very high price tags, but Selby said cost-effectiveness won’t be the focus of the research, as PCORI’s authorizing legislation dictates that the organization focus on comparative clinical outcomes. However, patient financial impacts, such as out-of-pocket costs, could be considered in the research, as one of many issues affecting patients.

MS is not the only therapeutic area being studied with funds from PCORI. Other recent PCORI-funded research looked at issues ranging from chest pain, to type 2 diabetes, to opioid prescribing