Hideki Garren, MD, PhD

“Patients don’t have to wait for visits to their doctor’s office every 6 months or every 3 months. We can look for progression in these patients.”

As part of the mixture between the desire to collect quality data for physicians and the efforts of an ongoing open access trial, Genentech has developed an app to collect information about patients with MS to improve physician insight.

At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany, Hideki Garren, MD, PhD, the Global Head of Neuroimmunology at Genentech, spoke with 

 about this development, and the plans for the larger, ongoing trial.

An original proof-of-concept trial to assess the tool’s capability showed a high rate of adherence and satisfaction with the tool. The application, which is downloadable on a smartphone, is used to asses both passive and active measures of disease progression. This allows both the patients and physicians to access the information about the clinical status of their disease.

Currently, the program is initiating an open-access trial, called FLOODLIGHT OPEN, which is open for any patient in the United States and Canada—whether or not they have MS&mdash;to join, with an ultimate goal of gathering data on 5000 patients in the next decade.

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The smartphone application-led program, Floodlight Open, recently initiated in the US and Canada.

Hideki Garren, MD, PhD: Measuring MS Progression With Floodlight Open

“In PPMS, the preservation of upper extremity function is very important, especially as patients advance.”

At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany, data from the ORATORIO trial of ocrelizumab (Ocrevus, Genentech) in patients with primary progressive multiple sclerosis (PPMS) was presented. Those data included an assessment of upper limb function as measured by the 9-hole peg test.

Ultimately, ocrelizumab showed promising results in helping patients maintain this function. This is an important finding for these patients, as those with advanced disease often have impairments in the function of their lower body, making upper extremity function ever more important.

Now, another phase III trial, the first of its kind, called ORATORIO-HAND, will be exploring this exact measure of upper extremity function in more advanced patients with PPMS. It is set to begin in the first half of 2019, and will seek to enroll 1000 patients with Expanded Disability Status Scale scores between 3 and 8.

To find out more about the upcoming trial, Hideki Garren, MD, PhD, the Global Head of Neuroimmunology at Genentech, sat with 

 to discuss it while on site at ECTRIMS 2018. 

The Global Head of Neuroimmunology at Genentech discussed the upcoming phase III trial of ocrelizumab while on-site at ECTRIMS 2018.

Hideki Garren, MD, PhD: The ORATORIO-HAND Trial in PPMS

"The story actually goes all the way back to 2015, at ECTRIMS."

, at the American Academy of Neurology’s (AAN) 70th Annual Meeting in Los Angeles, California, to discuss the history of a well-known therapy for multiple sclerosis: ocrelizumab (Ocrevus).

The group medical director of neuroscience at Genentech spoke about the therapy’s beginnings, with the unblinded data presentation of the OPERA trials at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting a few years back. Now, the OPERA trials are presenting additional data at AAN, this time of an open-label extension period.

Now that the patients in the study have been followed for 4 years, including a switch after year 2 from interferon ß-1a to ocrelizumab, the findings have revealed additional information that could aid in better treatment of patients with MS. Garren mentioned the findings showed that those who had been treated with ocrelizumab for the entire 4 years had less disease progression than those who switched to the therapy, highlighting the need to treat patients earlier. He also noted that this data included measurements of cognition for the first time.

Additionally, Garren spoke to the need for a biomarker in MS, and how neurofilament light, or NFL, may be one of the best available, as it has indicated a decline in cognition and disability—and how ocrelizumab reduced its levels.

The group medical director of neuroscience at Genentech discussed the history of a well-known therapy for multiple sclerosis: ocrelizumab (Ocrevus).

Author | Hideki Garren, MD, PhD

Articles

Hideki Garren, MD, PhD: Measuring MS Progression With Floodlight Open

Hideki Garren, MD, PhD: The ORATORIO-HAND Trial in PPMS

Hideki Garren, MD, PhD: Past and Future Ocrelizumab Analyses