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Abstract Number: 0798

A Randomized, Double-blind Phase 3 Study Comparing the Efficacy, Safety and Immunogenicity of PF-06410293 (Abrilada™), an Adalimumab (ADL) Biosimilar, and Reference ADL (Humira®) in Patients with Moderate to Severe Active RA: Results from Weeks 52-92

Roy Fleischmann1, Daniel Alvarez2, Amy Bock3, Carol Cronenberger4, Ivana Vranic5, Wuyan Zhang6 and Rieke Alten7, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2Pfizer, Collegeville, PA, 3Pfizer, Cambridge, MA, 4Pfizer, Collegeville, 5Pfizer, Tadworth, United Kingdom, 6Pfizer, New York, 7Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany

Meeting: ACR Convergence 2020

Keywords: Anti-TNF Drugs, Biologicals, clinical trial, rheumatoid arthritis

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Session Information

Date: Saturday, November 7, 2020

Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World

Session Type: Poster Session B

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

Background/Purpose: To evaluate the long-term safety, immunogenicity (IG), and efficacy of the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF), in patients (pts) with moderate to severe active RA who continued ADL-PF treatment throughout 78 weeks (wks) or who switched from reference ADL sourced from the European Union (ADL-EU) to ADL-PF at wk 26 or wk 52 in a randomized, double-blind, comparative clinical trial (NCT02480153). This report includes results from wks 52-92 (including 16-wk follow-up [FU]).

Methods: Eligible pts met 2010 ACR/EULAR RA diagnosis criteria for ≥4 months, had an inadequate response to MTX, and had received ≤2 doses of 1 lymphocyte-depleting or non-ADL biologic. Pts stratified by geographic regions were initially randomized (1:1) in treatment period 1 (TP1) to ADL-PF or ADL-EU (40 mg subcutaneously every other wk), both with MTX (10–25 mg/wk). The primary endpoint was ≥20% clinical improvement of ACR criteria (ACR20) at wk 12. Secondary efficacy endpoints included ACR20 other than at wk 12, DAS28; 4 components based on high-sensitivity CRP (DAS28-4[CRP]), and other measures of clinical response or remission. At wk 26 (start of TP2), pts receiving ADL-EU were blindly re-randomized (1:1) to remain on ADL-EU or transition to ADL-PF for 26 wks. At wk 52 (start of TP3), all pts received open-label treatment with ADL-PF for 26 wks; 3 groups (gps) were evaluated corresponding to the treatment sequence during the study: biosimilar; wk 26 switch; wk 52 switch.

Results: Of the randomized TP1 pts (N=597), 552 pts entered TP2. At wk 52, all pts remaining on ADL-EU were switched to ADL-PF; 507 pts continued to participate in TP3. The majority of TP3 pts were female (78.1%) and White (86.6%). ACR20 response rates and DAS28-4(CRP) scores were sustained and comparable across gps (Table). ADL-PF was generally well tolerated, with a comparable safety profile across gps. Incidence of treatment-emergent adverse events (AEs) during TP3 and FU was 42.6% (biosimilar), 37.0% (wk 26 switch), and 50.8% (wk 52 switch); 3 (0.6%) pts overall (all in the wk 52 switch gp) reported treatment-related serious AEs. There was 1 death (wk 52 switch gp). Pre-dose (TP3) anti-drug antibody (ADA) prevalence at wk 52 was 41.5%, 42.5%, and 48.3% for the biosimilar, wk 26, and wk 52 switch gps, respectively. The incidences of pts with a first positive ADA result during TP3 or FU, among pts who were ADA negative on entry to TP3, were 8.9%, 6.3%, and 8.3% for the biosimilar, wk 26, and wk 52 switch gps, respectively; overall, incidences of pts with ADAs in TP3 and FU were comparable among gps (46.1%, 46.5%, and 54.2%, respectively).

Conclusion: Results from TP3 and FU (wks 52–92) are consistent with earlier findings from this study, demonstrating no clinically meaningful differences in safety, IG, and efficacy between treatment gps, independent of a single treatment switch from ADL-EU to ADL-PF at wk 26 or wk 52.


Disclosure: R. Fleischmann, Pfizer, 2, 5; D. Alvarez, Pfizer, 1, 2; A. Bock, Pfizer, 1, 2; C. Cronenberger, Pfizer, 1; I. Vranic, Pfizer, 1, 2; W. Zhang, Pfizer, 1, 2, AbbVie, 1, Abbott, 1; R. Alten, Pfizer, 2, 8, Gilead Sciences, Inc., 2, Novartis, 2, AbbVie, 2, 5, Bristol-Myers Squibb, 2, 5, Lilly, 2, 5, UCB, 2, 5.

To cite this abstract in AMA style:

Fleischmann R, Alvarez D, Bock A, Cronenberger C, Vranic I, Zhang W, Alten R. A Randomized, Double-blind Phase 3 Study Comparing the Efficacy, Safety and Immunogenicity of PF-06410293 (Abrilada™), an Adalimumab (ADL) Biosimilar, and Reference ADL (Humira®) in Patients with Moderate to Severe Active RA: Results from Weeks 52-92 [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/a-randomized-double-blind-phase-3-study-comparing-the-efficacy-safety-and-immunogenicity-of-pf-06410293-abrilada-an-adalimumab-adl-biosimilar-and-reference-adl-humira-in-patie/. Accessed January 18, 2021.
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