Jason Freeman, MD, MBA, and James Stankiewicz, MD, discuss the poster “Real-World Experience With Ofatumumab” presented at ACTRIMS 2023. Sponsored By Novartis.
Jason Freeman, MD, MBA: Welcome to ACTRIMS 2023. I'm your host, Dr Jason Freeman, Medical Director, Novartis Medical Affairs, providing you with updates from ACTRIMS 2023. The information herein is provided for disease educational purposes only, and is not intended to be, nor does it imply medical or diagnostic advice.
Indications and usage of ofatumumab. Ofatumumab is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis to include clinically isolated syndrome, relapsing remitting disease, active secondary progressive disease in adults. Contraindications: active HPV infection. Warnings and precautions: infections: delay ofatumumab administration in patients with an active infection until the infection is resolved. Vaccination with live attenuated, or live vaccines is not recommended during the treatment with ofatumumab and after discontinuation until B-cell repletion. Injection-related reactions: management for injection-related reactions depends on the type and severity of the reaction. Reduction in immunoglobulins: monitor the level of immunoglobulin at the beginning, during and after discontinuation of the treatment with ofatumumab until B-cell repletion. Consider discontinuing ofatumumab if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise. Fetal risk: may cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for the 6 months after stopping ofatumumab. Adverse reactions: most common adverse reactions (incidents greater than 10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions. Please see the full prescribing information for additional information.
Jason Freeman, MD, MBA: Joining us today from ACTRIMS is Dr James Stankiewicz, Executive Medical Director with Novartis Pharmaceuticals. Welcome, James.
James Stankiewicz, MD: Thank you.
Jason Freeman, MD, MBA: We're going to discuss a poster titled “Real-World Experience With Ofatumumab.” So, tell us a little bit about real-world evidence studies and really what they mean to patients and clinicians.
James Stankiewicz, MD: So, I think fundamentally real-world evidence studies are different from randomized controlled studies, which actually helps you understand if you're a clinician, what is that going to look like. Clinical trials have restricted inclusion-exclusion criteria and I think one of the things that most often is different is that the age of enrollment oftentimes is limited with real-world studies. For example, the age of enrollment can be higher and there aren't exclusions related to patients that are more likely to be infected or run into trouble so it's a little bit of a different animal, and there are advantages and disadvantages to each type of trial design.
Jason Freeman, MD, MBA: What are some of the advantages?
James Stankiewicz, MD: So, the advantages are, again, I think a little bit like what I said which just relate to a more inclusive population. You can see across the spectrum how a drug, for example, or an intervention affects patients more broadly.
Jason Freeman, MD, MBA: So, sort of getting to, as a clinician in dealing with patients, is this drug going to work for me in my situation versus an isolated clinical trial setting?
James Stankiewicz, MD: Yeah, I wouldn't say it's that dramatic. I think there are advantages to trials as well but there can be certain populations that are not captured in a clinical trial. Again, I think a nice example would be a patient that's 65, for example, wouldn't be captured in, I think, any of the phase 3 MS [Multiple Sclerosis] trials. Whereas in a real-world study, there's no restriction for age and so you get to see in a subset of patients that are older, what happens potentially, for example.
Jason Freeman, MD, MBA: So, describe for us how real-world data was collected in this study, and what particular information was then analyzed?
James Stankiewicz, MD: So, this particular study was a study out of Australia. There were 140 patients that were enrolled in the study. It was basically, looking at experience on ofatumumab and seeing how patients did. The focus of this particular presentation was really more about where did the patients come from and why did they come onto ofatumumab?
Jason Freeman, MD, MBA: Got it. What are some of the results of patients then switching therapy in MS and some of the safety signals that were seen in this real-world setting?
James Stankiewicz, MD: They reported on why did patients switch and the main 2 medicines switched from were ocrelizumab and natalizumab. They were ultimately switched most often from natalizumab because of JC virus status and with ocrelizumab relating to proportion of patients that experienced infection. There were various other DMTs [disease-modifying therapies] that were captured but I think that's, to me, the main message of this work.
Jason Freeman, MD, MBA: Well, Dr Stankiewicz, thanks for your time today and we appreciate the information that you shared with us.
James Stankiewicz, MD: Sure. I'm glad to do it.
Jason Freeman, MD, MBA: Thank you for watching the ACTRIMS 2023 updates sponsored by Novartis. We look forward to seeing you at AAN 2023 for more exciting updates.
Transcript Edited for Clarity