Survival of Etanercept (ETN) Responders after Methotrexate (MTX) Failure When ETN Is Initiated As Mono or Combination Therapy or after MTX Withdrawal from ETN/MTX Combination in Long Standing Rheumatoid Arthritis (RA). a Single Center Retrospective Study

Edward C. Keystone¹, Abdulaziz ALKhalaf^2,3, Sabri ALSaeedi^4,5, Mosaab Makkawy^4,6, Deborah Weber⁷ and Daming Lin⁸, ¹Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ²Rheumatology Division, Medicine Department, UNIVERSITY OF TORONTO/Mount Sinai Hospital, Toronto, ON, Canada, ³Rheumatology Division, Medicine Department, King Saud University, Riyadh, Saudi Arabia, ⁴Rheumatology Division, Medicine Department, UNIVERSITY OF TORONTO/ Mount Sinai Hospital, Toronto, ON, Canada, ⁵Rheumatology Division, Medicine Department, King Fahd Hospital, Jeddah, Saudi Arabia, ⁶Rheumatology Division, Medicine Department, Prince Mohammad Bin Abdulaziz Hospital, Riyadh, Saudi Arabia, ⁷Advanced Therapeutics, Mt Sinai Hosp 2nd Floor 02-205, Toronto, ON, Canada, ⁸Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Biologics, combination therapies, etanercept and rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 10, 2015

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The long term sustainability of ETN as monotherapy (mono) or in combination (combo) with methotrexate (MTX) is uncertain in patients with longstanding RA responding to ETN after MTX failure.

Objectives: The purpose of this study was to evaluate the long term sustainability of ETN for efficacy in ETN responsive patients after MTX failure when initiated as mono or combo therapy.

Methods: A retrospective cohort based on a chart review of 140 pts from a single rheumatology center who initiated ETN as their first biologic was carried out. Only data from 104 (74.3%) pts who had achieved DAS 28 low disease or remission by 18 months (mo.) were considered for analysis in order to more stringently define secondary ETN efficacy failures in the survival analysis. Pts discontinuing ETN before 18 mo or for adverse effects at any time were excluded from the long term survival analysis. Three groups of pts were included in the long term survival analysis: (i) pts initiating combo ETN plus MTX, (ii) patients initiating ETN mono because of prior intolerance to MTX, (iii) patients initiating ETN mono after withdraw of MTX from the ETN/ MTX combo.

Results: Of the 140 total ETN treated pts, 36(25.7%) discontinued ETN for efficacy before 18 mo: 11 (7.9%) before 6 mo, 17 (12.1%) between 6-12 mo and 8 (5.7%) between 12-18 mo. In the 104 pts achieving low disease or remission for 18 mo, 93(82%) were women, mean (SD) age 52.4(12.6) with a disease duration of 22.4(9.7) years of which 71(77.2%) were seropositive. Baseline disease activity (at ETN initiation) of the 46 pts initiating ETN mono revealed a tender joint count (tjc) of 4.9(7.0) a swollen joint count (sjc) of 7.5(5.9), an ESR of 29.5(21.3) and DAS28 score of 4.3(1.4). Of 35 patients adding ETN to the MTX combo, the baseline (at MTX initiation) tjc was 4.9(5.1), sjc 9.1(5.9), ESR 40.4(31.1) and DAS28 score of 4.8(0.9). A separate population of 23 pts receiving combo therapy withdrew MTX (mean (SD) time from withdrawl was 21.8 (19.3) mo with a median of 16 mo). The baseline (at MTX initiation) tjc was 2.52(3.8), sjc 9.1(4.5), ESR 25.6(14.3) and DAS28 score of 3.8 (1.1) The results of the survival analysis of the 104 pts ( figure 1) revealed comparable survival of the all 3 groups at 10 years (log rank 0.8582). Survival of ETN after MTX withdrawl appeared greater than the other groups but its survival analysis was initiated 18 months after MTX withdrawl.

Conclusion: In this preliminary analysis of extremely long standing RA pts, ETN responders who achieve low disease or remission by18 months have a high likelihood of ETN sustainability whether initiating ETN as mono or combo therapy or withdrawing MTX from the combo. Larger pt populations need to be studied for confirmation of the results.

Image:

Survival curves in RA pts achieving low disease or remission after 18 months for biologic naïve patients initiating ETN mono therapy or adding ETN in combination with MTX, or initiating ETN mono after discontinuing MTX from combo therapy.

Disclosure: E. C. Keystone, Amgen, 2,Amgen, 5,Amgen, 9; A. ALKhalaf, None; S. ALSaeedi, None; M. Makkawy, None; D. Weber, None; D. Lin, None.

To cite this abstract in AMA style:

Keystone EC, ALKhalaf A, ALSaeedi S, Makkawy M, Weber D, Lin D. Survival of Etanercept (ETN) Responders after Methotrexate (MTX) Failure When ETN Is Initiated As Mono or Combination Therapy or after MTX Withdrawal from ETN/MTX Combination in Long Standing Rheumatoid Arthritis (RA). a Single Center Retrospective Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/survival-of-etanercept-etn-responders-after-methotrexate-mtx-failure-when-etn-is-initiated-as-mono-or-combination-therapy-or-after-mtx-withdrawal-from-etnmtx-combination-in-long-standing-rheumato/. Accessed May 25, 2022.

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