In a study led by JÃ©rÃ´me de Seze, MD, PhD, from the University Hospital of Strasbourg in France, researchers aimed to uncover more information on the medication, ocrelizumab, in patients with primary progressive multiple sclerosis (PPMS).
Data is one thing, but patient reports are another. This relates to all areas of medicine, but specifically we’re talking about multiple sclerosis at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London, England.
In a study led by Jérôme de Seze, MD, PhD, from the University Hospital of Strasbourg in France, researchers aimed to uncover more information on the experimental medication, ocrelizumab, in patients with primary progressive multiple sclerosis (PPMS).
At last year’s ECTRIMS conference in Barcelona, Spain, ocrelizumab yielded positive pivotal trial results in a pair of phase 3 studies. Further research went on to examine adverse events — which occurred in more than 25% of patients during the first transfusion. Now the newest data is talking about patient-reported outcomes with the treatment.
Ocrelizumab, a humanized monoclonal antibody, works by targeting certain CD20+ B cells. In order to identify efficacy and safety, the team conducted a phase 3 trial, called ORATORIO, using patients with PPMS. The cohort was randomized in a two-to-one ratio to either receive ocrelizumab 600 mg or placebo intravenously as two 300 mg infusions 14 days apart, every 24 weeks for at least 120 weeks. Treatments continued until “a prespecified number of 12-week confirmed disability progression events occurred,” the researchers detailed.
The participants filled out two questionnaires, with the first being the Short Form-36 (SF-36). This form looks at the patient’s perception of functional health within eight concepts and it can be viewed by itself or with the Physical Component Summary (PCS) and Mental Component Summary (MCS). The second measure was the Modified Fatigue Impact Scale (MFIS) assesses how the medication impacts fatigue — including on physical, cognitive, and psychosocial functioning.
When the team looked at SF-36 and MFIS scores from baseline, Week 48, and Week 120, it became clear that ocrelizumab did not have a significant impact on all areas of measure.
“There was no statistically significant difference in the decline in SF-36 PCS in the ocrelizumab groups vs. the placebo group,” the authors determined. “However, ocrelizumab significantly improved SF-36 MCS compared with placebo from baseline to Week 120.”
On the other hand, the medication did cause a significant improvement in MFIS total score when compared to placebo. This was observed in all three MFIS subscale components and continued from baseline to the end of the trial period.
Although ocrelizumab did not cause an effect on SF-36 scores, fatigue measures on the MFIS significantly improved.
Ocrelizumab was accepted for priority review by the US Food and Drug Administration (FDA) in June 2016. Marketed under the name Ocrevus, it is the first investigational medicine for both relapsing and primary progressive forms of multiple sclerosis that researchers are seeking marketing authorization for.
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