Contributions
Abstract: P928
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Efficacy and safety of ocrelizumab were demonstrated in three phase 3 randomized controlled trials. This study evaluates generalizability to a real-world setting.
Objectives: Evaluate the effectiveness, safety and tolerability of ocrelizumab in clinical practice.
Methods: This is a prospective longitudinal cohort study. Patients were identified by chart review and data was abstracted from the electronic medical record. Patients had to be 18-75, start ocrelizumab after regulatory approval, be followed clinically for at least 6 months prior to starting ocrelizumab, and have a confirmed diagnosis of MS. Demographic data, disease course, disease duration, prior disease modifying therapies, baseline and monitoring MRIs, screening and monitoring laboratory assessments, infusion-related reactions (IRRs), on-treatment side effects, and quantitative neuro-performance and patient reported outcomes were collected.
Results: As of 14-MAY2018, a total of 748 patients have been treated at the Cleveland Clinic. We report the results of the first 191 patients with 6-month follow up. 56% had relapsing-remitting (RR) MS, 31% had secondary progressive (SP) MS, and 13% had primary progressive (PP) MS. Demographics were similar to the clinical trial population: median age 47, 61.3% women, 86.4% white, 10.5% black. Our population had longer disease durations (median 14 years), fewer clinical relapses (0.16 ± 0.36), and fewer enhancing lesions (18.9%) at baseline compared to clinical trials. 5/191 had a clinical relapse corroborated by exam or MRI (3 in the first 3 months). 3/112 with contrast MRIs had new enhancing lesions. 46/191 had at least 1 infection (primarily UTIs and URIs), 31/191 had at least one IRR, and 1/191 had a new diagnosis of cancer (basal cell carcinoma).
Conclusions: Ocrelizumab is a highly effective treatment for multiple sclerosis with similar adverse events to clinical trials. The rate of IRRs was approximately half of that seen in phase 3 trials. The patients started on ocrelizumab at our center had different disease characteristics, with longer disease durations, fewer relapses, and fewer enhancing lesions at baseline.
Disclosure: Brandon Moss is supported by National Multiple Sclerosis Society Institutional Clinician Training Award ICT 0002.
Erica Utigard: nothing to disclose
Laura Baldassari has received personal fees for serving on a scientific advisory board for Teva, and receives funding via a Sylvia Lawry Physician Fellowship Grant through the National Multiple Sclerosis Society (#FP-1606-24540).
Jeffrey Cohen has received personal fees for consulting from Adamas, Celgene, Convelo, EMD Serono, Novartis, and PendoPharm; speaking for Mylan; and serving as Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Daniel Ontaneda has received research support from National Multiple Sclerosis Society, National Institutes of Health, Patient Centered Research Institute, Race to Erase MS Foundation, Genentech, and Genzyme. He has also received consulting fees from Biogen Idec, Genentech/Roche, Genzyme, and Merck.
Abstract: P928
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Efficacy and safety of ocrelizumab were demonstrated in three phase 3 randomized controlled trials. This study evaluates generalizability to a real-world setting.
Objectives: Evaluate the effectiveness, safety and tolerability of ocrelizumab in clinical practice.
Methods: This is a prospective longitudinal cohort study. Patients were identified by chart review and data was abstracted from the electronic medical record. Patients had to be 18-75, start ocrelizumab after regulatory approval, be followed clinically for at least 6 months prior to starting ocrelizumab, and have a confirmed diagnosis of MS. Demographic data, disease course, disease duration, prior disease modifying therapies, baseline and monitoring MRIs, screening and monitoring laboratory assessments, infusion-related reactions (IRRs), on-treatment side effects, and quantitative neuro-performance and patient reported outcomes were collected.
Results: As of 14-MAY2018, a total of 748 patients have been treated at the Cleveland Clinic. We report the results of the first 191 patients with 6-month follow up. 56% had relapsing-remitting (RR) MS, 31% had secondary progressive (SP) MS, and 13% had primary progressive (PP) MS. Demographics were similar to the clinical trial population: median age 47, 61.3% women, 86.4% white, 10.5% black. Our population had longer disease durations (median 14 years), fewer clinical relapses (0.16 ± 0.36), and fewer enhancing lesions (18.9%) at baseline compared to clinical trials. 5/191 had a clinical relapse corroborated by exam or MRI (3 in the first 3 months). 3/112 with contrast MRIs had new enhancing lesions. 46/191 had at least 1 infection (primarily UTIs and URIs), 31/191 had at least one IRR, and 1/191 had a new diagnosis of cancer (basal cell carcinoma).
Conclusions: Ocrelizumab is a highly effective treatment for multiple sclerosis with similar adverse events to clinical trials. The rate of IRRs was approximately half of that seen in phase 3 trials. The patients started on ocrelizumab at our center had different disease characteristics, with longer disease durations, fewer relapses, and fewer enhancing lesions at baseline.
Disclosure: Brandon Moss is supported by National Multiple Sclerosis Society Institutional Clinician Training Award ICT 0002.
Erica Utigard: nothing to disclose
Laura Baldassari has received personal fees for serving on a scientific advisory board for Teva, and receives funding via a Sylvia Lawry Physician Fellowship Grant through the National Multiple Sclerosis Society (#FP-1606-24540).
Jeffrey Cohen has received personal fees for consulting from Adamas, Celgene, Convelo, EMD Serono, Novartis, and PendoPharm; speaking for Mylan; and serving as Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.
Daniel Ontaneda has received research support from National Multiple Sclerosis Society, National Institutes of Health, Patient Centered Research Institute, Race to Erase MS Foundation, Genentech, and Genzyme. He has also received consulting fees from Biogen Idec, Genentech/Roche, Genzyme, and Merck.