Download THREE-MONTHLY LONG-ACTING ANTIPSYCHOTIC THERAPY

THREE-MONTHLY LONG-ACTING ANTIPSYCHOTIC THERAPY
RESULTS IN A BETTER TREATMENT CONTINUITY COMPARED TO A
ONE-MONTHLY OR BI-WEEKLY TREATMENT IN SCHIZOPHRENIA
Tedouri F1, Denee TR2, Malfait B3, Van Impe K2
1Janssen
Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium, [email protected]; 2Janssen-Cilag BV, Doctor Paul Janssenweg 150, 5026 RH Tilburg; 3Janssen-Cilag NV, Antwerpseweg 15-17,
2340 Beerse, Belgium.
INTRODUCTION AND OBJECTIVE
RESULTS
 Schizophrenia is a chronic and severe mental disorder that affects how
a person thinks, feels, and behaves. Typical and atypical long-acting
antipsychotic therapies that aim to improve symptoms of illness and
patient’s health-related quality of life (HRQL) are widespread available.
Treatment continuity is a key element to improve treatment outcomes
in schizophrenia patients. Treatment discontinuation has been
determined as a strong indicator of relapse1,2,3,; with each relapse
having a clinical and economic impact4, due to the high cost of
hospitalizations5. De Hert et al. demonstrated in a recent review that
patients who were continuously treated with an antipsychotic had three
times lower relapse risk than those who follow an intermittent
treatment strategy1.
 The objective of this research is to investigate the impact of a threemonthly long-acting antipsychotic therapy (LAT) versus one-monthly
and bi-weekly therapies, using real-world evidence (RWE) from
paliperidone
palmitate
one-monthly
(PP1M)
and
risperidone
microspheres (RM) LAT in Belgium and the Netherlands.
 Treatment continuity is higher for three-monthly LAT versus PP1M and
RM.
 Percentage increase in time on treatment in the base case scenario for
three-monthly LAT was 28% versus PP1M and 57% versus RM in
Belgium, and 15% versus PP1M and 46% versus RM in the Netherlands.
 In the additional scenario, the percentage increase in time on treatment
for three-monthly LAT was 32% versus PP1M and 61% versus RM in
Belgium, and 18% versus PP1M and 50% versus RM in the Netherlands.
Figure 3. Mean days on treatment in 1 year , ∆ = % increase in time on treatment
METHODS
 RWE studies assessing the treatment continuity in patients with
schizophrenia in Belgium and the Netherlands were used to investigate
the impact of a three-monthly LAT on time on treatment versus onemonthly and bi-weekly. These RWE studies were developed using the
IMS LifelinkTM Treatment Dynamics database in both countries6,7. Four
cohorts including patients who were treated in outpatient settings were
defined, two cohorts including patients treated with paliperidone
palmitate one-monthly (n=813) and risperidone microspheres (n=568)
in Belgium and two cohorts including patients treated with paliperidone
palmitate one-monthly (n=524) and risperidone microspheres (n=411)
in the Netherlands.
 The mean treatment duration in the first 12 months for PP1M and RM
was determined by calculating the area under the Kaplan-Meier curve of
patients who were still on treatment8.A half-cycle correction was applied
to avoid overestimation of time on treatment9.
Simulation of 90-day therapy interval:
 PP1M estimates were used to simulate time on treatment of a threemonthly interval antipsychotic. Two scenarios, a base case and an
additional scenario were formulated to show the sensitivity of the
results when using different assumptions.
 The base case scenario was built on the theoretical assumption that
patients treated with three-monthly LAT could only discontinue after
three months of every administration and it was assumed that the
proportion of patients who were still on treatment on the three-monthly
LAT drops after every three months to the level of PP1M (figure 1).
 In the additional scenario, it was assumed that the proportion of
patients who were on three-monthly treatment drops after three
months to the level of patients who were on PP1M after one month and
then mimics the remainder of the PP1M survival curve (figure 2).
 The mean number of treatment days per cohort and per country were
calculated accordingly as shown in figure 3.
Figure 1. Time on medication in
Belgium as described in the base
case scenario
DISCUSSION
 Longer drug coverage periods can reduce the number of therapy
administrations and results in an improved treatment continuity
reducing the relapse risk due to longer drug half-life elimination10. In
addition, less frequent therapy administrations (three-monthly) result in
a higher quality of life than those with more frequent administrations
(one-monthly and bi-weekly)11. A recent analysis has shown that
therapies with extended coverage and longer administration interval
reduce the risk of relapse after discontinuation10.
 The assumption made in the base case can be considered conservative
as it shows that three-monthly antipsychotic therapy has the same
continuation rate as the one-monthly therapy after 90 days of
treatment but higher time on treatment due to the fact that patients
could only discontinue the three-monthly therapy after 90 days of
administration. The additional scenario is likely based on a realistic
assumption, since the continuation rate after the first administration
interval is similar to that of PP1M.
 The European Medicine Agency has recently granted the marketing
authorization to paliperidone palmitate three-monthly formulation
(Trevicta®) which is the first therapy to be administered only four times
a year in schizophrenia for patients who have been stable on treatment
with PP1M12.
LIMITATIONS
 There is more than one reason for patients to discontinue their
treatments. Unfortunately, those reasons were not identified in the
previous analyses that were conducted in Belgium and the
Netherlands6,7, thus it was assumed in the simulation of 90-day therapy
interval that factors affecting treatment discontinuation of the threemonthly therapy are similar to those of the one-monthly therapy.
 This analysis was based on conservative assumptions, therefore further
investigation on the impact of administration interval on time on
treatment in the real world is needed.
CONCLUSIONS
Figure 2. Time on medication
in Belgium as described in the
additional scenario
 Therapies with a longer administration interval can prolong time on
treatment and decrease the relapse risk.
 Therapies with less frequent administration allow physicians to focus on
other elements of patient care, and patients to focus on aspects in life
that means most to them.
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