A COMPARISON OF EFFICACY AND SAFETY OF SUSTAINED-RELEASE LANREOTIDE (LANREOTIDE AUTOGEL) IN JAPANESE AND EUROPEAN ACROMEGALIC PATIENTS

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 130-162-Neuroendocrinology
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-154
Akira Shimatsu*1, Akira Teramoto2, Naomi Hizuka3, Kazuo Kitai4, Joaquim Ramis5 and Kazuo Chihara6
1National Hospital Organization Kyoto Medical Center, Kyoto, Japan, 2Nippon Med Sch, Tokyo, Japan, 3Tokyo Women's Medical Univ, Tokyo, Japan, 4Teijin Pharma Limited, 5Ipsen Pharma, S.A, Barcelona, Spain, 6Hyogo Prefectural Kakogawa Med C, Kakogawa-City, Japan
Introduction: Efficacy and safety of lanreotide Autogel (LAN) are well established in European patients, but not as yet in Japanese patients. We compare the data from our new phase 3 study in Japanese patients [1], with an earlier phase 3 study in European patients [2].

Methods: Both studies were prospective, open-label multicenter trials that enrolled acromegalic patients who were treatment naïve or previously treated (after washout) to receive 4 injections of LAN every 4wks at 90mg over a 16wk fixed-dose phase, followed by 8 or 9 injections of LAN 60, 90 or 120mg (according to GH/IGF-I levels and/or clinical symptoms) during a dose-titration phase of 32 or 36wks (in European and Japanese study, respectively). GH and IGF-I levels, clinical symptoms, and safety were assessed in both studies. In addition, pituitary tumor size was evaluated (using central assessment) in the Japanese study.

Results: In the Japanese study (n=32), LAN resulted in GH levels ≤2.5ng/mL in 15 of 32 patients (43%) at 52wks.  In the European study (n=63), GH assay were different, so GH could not be compared. IGF-I levels were within the normal reference range in similar proportions of Japanese (17/32 patients; 53% [95% CI 35–71]) and Europeans (27/63 patients; 43% [95% CI 31–55]) at end of treatment. In Japanese patients, the mean IGF-I SD score decreased from 6.0 to 2.1, a tendency towards normal range (this was not evaluated in the European study). The Japanese study also found that 7 of 22 evaluable patients (32%) achieved tumor size reduction of ≥ 30% (from baseline to wk52). In both studies, LAN improved acromegaly symptoms, including swelling of extremities (16/25 patients [64%] and 23/29 patients [79%] respectively) and excessive perspiration (13/18 patients [72%] and 21/26 patients [81%] respectively). LAN had a similar safety/tolerability profiles in both studies; the most common adverse events (AEs) were gastrointestinal symptoms, such as diarrhea (36/63 patients [57%] and 17/32 patients [53%] respectively). There was only 1 patient with treatment-related serious AE in the Japanese study (upper abdominal pain), and 1 in the European study (thrombophlebitis).

Conclusions: Lanreotide Autogel provided sustained control of GH and IGF-I levels, improved acromegaly symptoms, and was well tolerated in Japanese patients with acromegaly or pituitary gigantism. These findings indicate that treatment effects in Japanese patients are generally consistent with those in European patients.

[1] A Shimatsu, A Teramoto, N Hizuka, K Kitai, J Ramis, K Chihara. Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism. Endocrine Journal 2013[Advance Publication Released: January 19, 2013]. Available at:  https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ12-0417/_article [2] Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B. Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol 2008;69(2):299–305.

Disclosure: AS: Medical Advisory Board Member, Teijin Pharma Limited. AT: Medical Advisory Board Member, Teijin Pharma Limited. NH: Medical Advisory Board Member, Teijin Pharma Limited. KK: Employee, Teijin Pharma Limited. JR: Employee, Ipsen. KC: Medical Advisory Board Member, Teijin Pharma Limited.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

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