We hope you are off to a happy and prosperous new year! In my last Evidence Base column within the Q4 e-newsletter, I talked about the importance of real world evidence (RWE) for establishing the safety and efficacy of new treatments for our patients and for obtaining the support we need from payors to ensure broader access to care for our patients. As a Public Benefit Corporation, Osmind believes that it is our duty to contribute to RWE using aggregated de-identified data extracted from the EHR.
To that end, we are pleased to report that our manuscript “A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings” will be published in the Journal of Affective Disorders on 01/11/22. It is the largest published real-world analysis of KIT outcomes in a community sample to date.
As persons deeply invested in bringing off-label treatments to patients in need, we hope you can use this paper to obtain broader access to care for your patients and to attract new clients to your practice.
We invite you to attend a webinar to participate in an exclusive preview of the results on Thursday, January 6th at 5pm PT/ 8pm ET. I will host a discussion along with my colleague, Osmind's Medical Director, Dr. Carlene MacMillan, covering:
- An overview of the study and the power of real world evidence (RWE)
- How to best utilize this study for your clinic’s success
- How Osmind can be used for research
You may register and submit questions for the webinar here.
Abstract and Summary of Key Points
- Description: We analyzed ketamine infusion therapy (KIT) outcomes in 537 depressed patients with complete data collected via the MoodMonitor App between 2016 to 2020 at one of 178 community practices across the United States. This is the largest published real-world analysis of KIT outcomes in a community sample to date.
- Efficacy: The most common induction protocol by far was 6 infusions in 2-3 weeks. We observed a 54% response rate and 30% remission rate at 2-4 weeks post-induction. Response was equal across all levels of baseline severity but the largest changes were observed in the most severe patients. Just over 40% of patients who had suicidal ideation (SI) at baseline no longer experienced this symptom after induction and over 70% of patients experienced an overall improvement in SI. After induction 8% of patients worsened.
In contrast to our findings, a previous RWE study of 85 patients by Sakurai and colleagues 2020 reported a response rate of ~20%. While our response rates diverge from those of the Sakurai group, our data is roughly in line with that of Phillips et al. (2019), Singh et al. (2016), Aust et al. (2019) and Wilkinson et al. (2018) who observed response rates between 45-59% after an induction protocol.
- Maintenance and Relapse: Kaplan-Meier analyses showed that a patient who responds to KIT induction has an approximately 80% probability of sustaining response at 4 weeks and approximately 60% probability at 8 weeks, even without maintenance infusions. Just over 50% of patients elected to go into maintenance treatment. The average number of maintenance infusions was between 2-3. We acknowledge that these maintenance statistics maybe upwardly biased by economic and convenience factors. Patients want an expensive treatment to work and this could lead to an upward bias of response and durability. It's also expensive to take time off work to get the treatment. On the other hand, Sakurai et al. (2020) reported a relatively low response rate and a low number of maintenance infusions from data garnered under similar conditions (patient payment for treatment, real world setting), suggesting that any possible upward skewing of response rates is unlikely to fully explain our results.
- Takeaway: The response to KIT for depression was rapid and robust in this study, although we acknowledge that the lack of demographic and clinical data temper conclusions. Still, taken together with findings from findings from previous clinical trials, the true response rate is probably between 20-50% which is comparable to that of TMS, a treatment currently covered by insurers. The response in this study was also relatively durable. Most patients only return for 2-3 boosters over the course of several months after induction, presumably because the treatment is so effective, although cost and inconvenience could also explain the relatively short duration of care. Osmind plans additional longer term follow up studies on KIT patients, in our own data set and in collaboration with others. We hope that with richer demographic and clinical data we can better assess patient safety and the degree to which treatment resistance affects KIT outcomes.
We enthusiastically welcome your feedback. If you have any questions and/or concerns about this article, you may contact me directly at email@example.com. And you can read more about Osmind's research initiatives here.