Post-Psych Congress Recap Part 2: Drs Chepke and Goldberg Discuss REAL-BD Study Exploratory Results for Aripiprazole Monohydrate Every-Two-Month Formulation in Adults Living With Bipolar I Disorder

Drs Craig Chepke and Joseph Goldberg review new data, including medication management and healthcare resource utilization outcomes, during the 12 months after transition to aripiprazole monohydrate every-2-month long-acting injectable in bipolar I disorder.

View the Real-World, Long-Term Impact of Transitioning From Oral Antipsychotics or Aripiprazole Once-Monthly to Aripiprazole 2-Month Ready-To-Use in Adults Diagnosed with Bipolar I Disorder: Exploratory Outcomes from the REAL-BD Study poster here.

Craig Chepke, MD: Hey, Joe, thanks for making time again. I'm excited to talk some more about the REAL-BD study. The hospitalization findings supporting clinical stability were the headlined primary outcome measure in the first poster, but after our last conversation, I went back to the second REAL-BD poster. And this one looks at what was happening around the rest of the treatment experience, right?

Joseph Goldberg, MD: Exactly. This was the exploratory analysis that asked whether other aspects of care changed during the same 12 months after transitioning to aripiprazole monohydrate 2-month ready-to-use 960 mg, that’s Ari every-2-month formulation, for adults living with bipolar I disorder.

Chepke: So, the 2 things that immediately caught my eye were psychotropic medication burden and healthcare resource use.

Chepke: Before we dive into the numbers, give me a quick refresher on what this analysis was looking for.

Goldberg: Sure. This is the same REAL-BD cohort and pre-post design that we reviewed in the first video: 72 adults living with bipolar I disorder, comparing outcomes during the 12 months before and after transition from an oral antipsychotic or aripiprazole monohydrate once-monthly 400 mg, also known as AOM 400, to Ari every-2-month formulation. And the exploratory questions were: did the number, or burden, of prescribed psychotropic medications change? Did treatment patterns change? Did healthcare visits and hospitalizations change? And, what did psychiatric hospitalization look like across clinically relevant subgroups?

Chepke: Okay. So, the second poster is really asking whether the primary hospitalization finding is part of a broader pattern of how these people living with bipolar I disorder were being managed.

Goldberg: That's a good way to put it.

Chepke: Thanks. Let's start with the prescribed psychotropic medication numbers. What changed?

Goldberg: Well, the average number of prescribed psychotropic medications decreased from 2.8 pre-index to 2.0 post-index—an average difference of 0.8 medications.

Chepke: So, practically speaking, that's almost 1 fewer psychotropic medication per adult living with bipolar I disorder, on average. In bipolar I, where polypharmacy is common, that could be meaningful. A less burdensome regimen may reduce some of the challenges that come with managing multiple medications—like drug interactions, adverse effects, and adherence.

Goldberg: Well, absolutely. Efforts to simplify overall psychotropic drug regimens in people with bipolar I disorder is an important yet challenging goal. Poor adherence to medication regimens is unfortunately common in bipolar disorder, where people may find themselves taking 3 or 4, or even more psychotropic drugs. And, controlled trials are now needed to better affirm these initial findings. We saw fewer prescribed psychotropic medications after transitioning to Ari every-2-month formulation; we don't know which medications were removed, why they were removed, or whether that translated to better adherence or tolerability. 

Chepke: Right. So, the takeaway isn't necessarily “less medication is better”—it's that the medication regimen appeared less complex after transition to Ari every-2-month formulation, which to me, is an interesting real-world finding to consider alongside the clinical outcomes.

Goldberg: Exactly.

Chepke: And what about treatment changes?

Goldberg: The average number of any treatment changes decreased from 1.8 to 1.1 during  REAL-BD. Looking at individual categories of medication adjustments, such as initiations, augmentations, switches, and dose adjustments, each decreased significantly; discontinuations increased numerically but not with statistical significance.

Chepke: So, each of these types of modification to a patient’s medication regimen were less frequent after transition to Ari every-2-month formulation, but we shouldn't infer clinician intent.

Goldberg: Exactly.

Chepke: The other result that stood out to me was healthcare resource utilization. Tell me what you saw there?

Goldberg: The average number of healthcare visits and hospitalizations decreased from 0.6 pre-index to 0.0 post-index. It’s an average difference of 0.5 when accounting for rounding.

Chepke: Wow, that's a pretty direct measure—fewer recorded healthcare visits and hospitalizations in the post-index period.

Goldberg: Yes, it tells us what was observed, but it doesn't establish why the utilization changed.

Chepke: Let’s talk about that subgroup table. It’s dense, but one thing is hard to miss in my eye: that there were no post-index inpatient psychiatric hospitalizations in any of the subgroups you looked at.

Goldberg: That's correct. The analysis looked across age, sex, race, education, employment, insurance, geographic region, and lead-in treatment. No post-index inpatient psychiatric hospitalizations were observed in any of those assessed subgroups. I want to note, though, that the subgroup analyses were limited by small sample sizes.

Chepke: Yeah, I think that’s the most useful way to read that table: descriptive context around the overall hospitalization finding, and not a basis for subgroup treatment selection.

Goldberg: Yes, exactly.

Chepke: Okay, so, let’s sum it up. When you put the 2 posters together, what do you think the exploratory analysis finds?

Goldberg: Well, the first poster focused on major clinical outcomes, especially psychiatric hospitalization. The second broadens the picture. After transition to Ari every-2-month formulation, the cohort had fewer prescribed psychotropic medications, and the majority of medication adjustments occurred less frequently. Healthcare resource utilization was lower, and no post-index psychiatric hospitalizations were observed within any assessed subgroups. The subgroup analyses add descriptive context to the hospitalization result.

Chepke: Yeah, and the key here is not to overstate it. These are exploratory findings from a retrospective pre-post study, so while they're useful for describing the real-world treatment course, they remain hypothesis-generating only.

Goldberg: Exactly. What they do is add context. Without a comparator group, we can’t prove causality, but alongside the primary findings, these analyses help us understand how Ari every-2-month formulation may change a patient’s treatment course across several dimensions of care that matter when we're thinking about long-term bipolar I disorder maintenance and clinical stability.

Chepke: Yeah, that's really helpful. Thanks so much for walking me through both posters, Joe. I definitely got a lot more out of them than I did from just catching the posters between sessions.

Goldberg: Anytime, Craig. Glad we finally got to compare notes.

Chepke: Thank you for joining our discussion on the REAL-BD study. As a reminder, the posters with full details of the REAL-BD study are available at the links provided.

Craig Chepke, MD

Dr Craig Chepke is a board-certified psychiatrist in clinical practice as the medical director of Excel Psychiatric Associates in Huntersville, North Carolina. He serves as an adjunct associate professor of psychiatry for the Atrium Health Psychiatry Residency Program and is the chief medical officer of Psych Congress. As part of an interdisciplinary treatment team in his practice, he employs a person-centered care model to tailor treatments to each individual's needs, integrating traditional pharmacotherapy with psychotherapeutic and physical health and wellness interventions. His clinical and academic interests include serious mental illness, movement disorders, ADHD, and sleep medicine. Dr Chepke has been recognized as a distinguished fellow of the American Psychiatric Association and is a recipient of the National Alliance on Mental Illness Exemplary Psychiatrist Award. 

Joseph Goldberg, MD

Dr Joseph Goldberg is a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai. He is also the immediate-past president of the American Society of Clinical Psychopharmacology and deputy editor-in-chief of the Journal of Clinical Psychiatry. Dr Goldberg attended medical school at Northwestern University. He completed his residency and chief residency in psychiatry, as well as a fellowship in psychopharmacology, at the Payne Whitney Clinic, New York Presbyterian Hospital. He later served there as faculty and was the site principal investigator at Weill-Cornell Medical Center for the NIMH STEP-BD program. He has published over 260 peer-reviewed papers on bipolar disorder, as well as 5 books on bipolar disorder and psychopharmacology. Dr Goldberg is a distinguished life fellow of the American Psychiatric Association and has been listed for many years in “Best Doctors in America” and Castle Connolly's "America's Top Doctors."