番茄社区

SAN DIEGO -- Patients with moderate to severe opioid use disorder (OUD) reported improvements in employment, health, and insurance status following a year of treatment with a once-monthly injectable depot buprenorphine formulation (Sublocade).

"Most of the drug studies up to now measure two things -- retention and drug use," said Walter Ling, MD, of the University of California Los Angeles, during a poster presentation at the here. "We don't measure getting a life."

Ling focused on the benefits of one patient-reported outcome (PRO) tool in particular, the Treatment Effectiveness Assessment (TEA), which can rapidly evaluates four aspects of a patient's life -- substance use, health domain, lifestyle domain, and community domain. "It takes 2 minutes," said Ling.

Using the TEA tool during monthly check-ups, the researchers asked patients' to describe changes in their lives with the four dimensions in mind and report a score from 0 to 10 for each. A total score was also calculated (0-40).

"This is intuitively what we do in our practice," said Ling.

In total, the study evaluated various PROs in 669 patients: 412 patients who were new to the study (de novo group) and received 12 months of Sublocade, and 225 patients who were from a previous 6-month phase III randomized trial and went on to receive an additional 6 months of treatment (roll-over group).

Other PROs used included the visual analog scale (VAS), SF-36v2 mental and physical component scores, EQ-5D-5L index, and Addiction Severity Index-Lite (ASI-Lite).

Comparing scores from baseline to week 49 in the de-novo group, significant improvement was seen with the SF-36v2 mental component score (difference 5.00, 95% CI 3.46 to 6.54).

And from baseline to week 49, each TEA domain saw a roughly 2- to 3-point improvement:

• Substance use, from 6.5 to 8.8
• Health domain, from 6.0 to 8.7
• Lifestyle domain, from 6.5 to 8.8
• Community domain, from 6.5 to 8.7

Total TEA score improved by roughly 9 points, from 25.4 to 35.0.

ASI scores also improved from baseline in all but one (alcohol use) of 7 problem areas. Notably, employment increased (44.2% to 51.2%) and insurance status remained stable (54.4% to 55.4%). And treatment satisfaction was reported by 88.8% at the end of study.

Other PROs in the de-novo group remained stable: EQ-5D-5L index (difference -0.01, 95% CI -0.03 to 0.02), VAS scores (difference 1.64, 95% CI -1.01 to 4.30), and SF-36v2 physical component score (difference 0.73, 95% CI -0.32 to 1.79).

In the roll-over groups (the second of which was a 32-patient placebo comparison arm), less pronounced improvements were seen from baseline to week 49 for TEA scores (roughly 1 point for each domain and 4 points for total TEA score), and for ASI problem areas.

EQ-5D-5L index and SF-36v2 scores were stable, as were the proportion of employed and insured patients. In the roll-over groups, 86% of patients on Sublocade reported treatment satisfaction versus 81% of those on placebo.

Sublocade was approved by the FDA in 2017 based on safety and efficacy data from 848 patients with moderate to severe OUD who took part in a randomized controlled trial as well as an open-label trial.

Postmarketing studies, required by the FDA as part of the approval, will assess various aspects of treatment with Sublocade: who might benefit from a higher dosing regimen, whether an initial dose stabilization period with sublingual buprenorphine is necessary, the feasibility of longer dose intervals than once per month, and determining the necessity of the loading dose during the first 2 months of treatment for patients with long-term stability on transmucosal buprenorphine.

Comment