There was a post-hoc analysis done to really understand the sustained impact of nipocalimab in the treatment of patients with generalized myasthenia gravis. So the background of this is that generalized myasthenia gravis is a fluctuating disease. So looking at one time point or one snapshot in time doesn’t paint a full picture in terms of how a patient might be doing. The Vivacity Phase III clinical trial in generalized myasthenia gravis was a randomized control trial that followed patients for 24 weeks, nipocalimab versus placebo...
There was a post-hoc analysis done to really understand the sustained impact of nipocalimab in the treatment of patients with generalized myasthenia gravis. So the background of this is that generalized myasthenia gravis is a fluctuating disease. So looking at one time point or one snapshot in time doesn’t paint a full picture in terms of how a patient might be doing. The Vivacity Phase III clinical trial in generalized myasthenia gravis was a randomized control trial that followed patients for 24 weeks, nipocalimab versus placebo. So in this post-hoc analysis, what we wanted to examine is the long-term or sustained improvements in certain pre-specified clinical outcome measures, mainly relying on the MG-ADL and QMG score. We defined meaningful clinical improvement as a greater than or equal to two-point improvement in the MG-ADL score and a meaningful clinical improvement in the QMG score of three or greater points. There were greater odds of achieving those improvements in eight weeks or more on the ADL and QMG score in the nipocalimab treatment. So for instance, the odds ratio of achieving that MCI was 1.9 compared to placebo in the nipocalimab arm and 3.9 on the QMG in the nipocalimab arm compared to placebo. We also looked at substantial clinical improvement. These were defined as an MG-ADL score of three or more points or a QMG score of four or more points. Again, the odds ratio of achieving those improvements in eight or more weeks was greater in the nipocalimab arm compared to placebo, 3.2 on the ADL versus 4.2 on the QMG, again favoring nipocalimab as compared to placebo. We looked at also more significant clinical improvements where those scores were defined as a four or more point improvement on the ADL score or a five or more point improvement on the QMG score. The odds ratios of achieving each of those was 4.2 and 3.8 respectively. Again, favoring nipocalimab compared to placebo in eight or more weeks during the randomized control clinical trial. We also looked at something called minimum symptom expression, which gets a lot of sort of attention. And minimal symptom expression is defined as an MG-ADL score of zero or one. So essentially, the patient is symptom-free or nearly symptom-free. And that was achieved in eight or more weeks, fourfold greater in the nipocalimab arm compared to placebo. Again, overall, looking at all of these outcome measures in a post-hoc analysis, nipocalimab was favored over placebo in terms of achieving long-term and more durable responses during the 24-week randomized control period, giving us additional information in terms of the impact on the clinical outcomes in participants with generalized myasthenia gravis included in the clinical trial. So again, the purpose here is not just to look at one single snapshot, as was pre-specified in the Phase III clinical trial, but get more color in terms of well how were the patients doing during that 24 week randomized control trial period which is really impactful when speaking with patients about consideration for a medication in terms of how are they going to be doing and faring once the medication has started. So again this provides a great information in terms of how are they going to be doing and faring once the medication is started. So again, this provides great information in terms of the perspective of nipocalimab’s impact and how that can be communicated and shared not only with clinicians treating patients with generalized myasthenia gravis, but also for what the patient experience might be like in terms of achieving clinical outcomes once nipocalimab is started in addition to their standard of care therapy. So while I provided a highlight or top-line results from our recent publication in 2026, I would refer anyone that wants to know additional information about the long-term impact, the durability of responses to the primary publication.
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