Real-World Maintenance Phase Persistence on Ustekinumab and Adalimumab in Ulcerative Colitis

Maryia Zhdanava,1 Sumesh Kachroo,2 Aditi Shah,1 Zhijie Ding,2 Patrick Lefebvre,1 Ruizhi Zhao,2 Caroline Kerner,2 Dominic Pilon1 1Analysis Group, Inc, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Horsham, PA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1-514-394-4469, Fax +1-514-394-4461, Email [email protected]: To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic.Methods: This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan–Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies).Results: Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively.Conclusion: At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab.Keywords: biologics, inflammatory bowel disease, outcomes researc

Abstract P4-14-04: A chart review of patient characteristics, treatment patterns and response in metastatic breast cancer patients treated with ado-trastuzumab emtansine in first-line therapy and beyond

Abstract Background: Ado-trastuzumab emtansine (T-DM1) approved for HER2+ unresectable locally advanced metastatic breast cancer (mBC) has been shown to significantly improve progression-free and overall survival in patients (pts) previously treated with trastuzumab and a taxane. However, little is known about real-world patterns and outcomes of T-DM1. Method: Pt-level data was collected from 90 US oncologists using an online chart extraction tool. Oncologists randomly selected eligible adult mBC pts started on T-DM1 on or after February 22nd 2013. Pts demographics, clinical information, and T-DM1 patterns and responses were described. Among pts whose T-DM1 response was assessed, univariate logistic regression models were used to assess the association between each factor and the probability of achieving complete response (CR). Results: Among the 303 pts, median follow-up after T-DM1 initiation was 5.1 months; 58.4% started T-DM1 in the 2nd half of 2014. Median age was 58 years, most pts were Caucasian (62.0%), median number of metastatic sites was 2, and 65.3% of pts had a mBC diagnosis (dx) within 1 year of the BC dx. Most common metastatic sites were liver (51.5%), lung/pleura (42.6%), and bone/bone marrow (41.6%). Median time from mBC dx to T-DM1 initiation was 7.1 months. 34.0% of pts started T-DM1 in 1st line for mBC, 55.4% in 2nd line, and 10.6% in later lines after mBC dx; most common prior treatments were trastuzumab, pertuzumab, and taxane. Best response achieved while on T-DM1 was CR in 17.5% of pts, partial response (PR) in 46.2%, stable disease in 11.2%, recurrence/progression in 3.6%, and the response was unknown in 21.5% of pts. CR/PR was achieved within a median of 5 months of T-DM1 initiation. At the end of follow-up, 80.2% were still on T-DM1, 3.3% had switched, 12.9% had discontinued without switching, and 3.6% were deceased. 44.9% of pts discontinued/switched after CR/PR and 32.7% after progression. When physicians were surveyed about their practice, 30.0% reported intention to interrupt T-DM1 after CR and 7.8% after an a priori determined number of cycles. Among pts whose response on T-DM1 was assessed (78.5%), race (Asian), initiation of T-DM1 shortly after mBC dx or in 1st line for mBC, ≤ 2 metastatic lesions, single metastatic site, and estrogen (ER)+ /progesterone (PR)+ at T-DM1 initiation were found to be significant predictors of CR, while pts who progressed between mBC dx and T-DM1 were less likely to achieve CR. Table 1. Factors Associated with CR Odds Ratio and 95% Confidence IntervalsAsian (vs non-Asian)2.9 (1.2 - 7.4)T-DM1 ≤ 1 year after mBC dx (vs &amp;gt; 1)3.2 (1.4 - 7.6)T-DM1 in 1st line after mBC dx (vs later lines)3.8 (2.0 - 7.2)≤ 2 metastases (vs&amp;gt;2)3.8 (1.9 - 7.6)1 metastatic site (vs &amp;gt;1)4.4 (2.3 - 8.4)ER+/PR+ (vs other status)4.9 (2.5 - 9.7)Progression between mBC dx and T-DM1 (vs no progression)0.2 (0.1 - 0.4) Conclusions: Most pts started T-DM1 as 1st or 2nd line therapy for mBC and were still treated with T-DM1 at the end of follow-up. CR/PR, assessed by treating oncologists, was achieved in &amp;gt;50% of pts within 5 months of T-DM1 initiation. Citation Format: Gauthier G, Guerin A, Zhdanava M, Wu E, Masaquel A, Barnett B. A chart review of patient characteristics, treatment patterns and response in metastatic breast cancer patients treated with ado-trastuzumab emtansine in first-line therapy and beyond. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-14-04.</jats:p