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Abstract Number: 0356

Bimekizumab Improves Patient-Reported Outcomes in Psoriatic Arthritis: 48-Week Results from a Phase 2b Study and Association Between Patient-Reported Outcomes and Disease Activity

Laure Gossec1, Philip Mease2, Alice Gottlieb3, Deepak Assudani4, Jason Coarse5, Barbara Ink6 and Laura Coates7, 1Sorbonne Université and Hôpital Universitaire Pitié Salpêtrière, Paris, France, 2Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 3Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 4UCB Pharma, Slough, United Kingdom, 5UCB Pharma, Raleigh, NC, 6UCB Pharma, Slough, 7University of Oxford, Oxford, United Kingdom

Meeting: ACR Convergence 2020

Keywords: Biologicals, Interleukins, Patient reported outcomes, Psoriatic arthritis

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Session Information

Date: Friday, November 6, 2020

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

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

Background/Purpose: Bimekizumab (BKZ), a humanized monoclonal IgG1 antibody that selectively neutralizes interleukin (IL)-17A and IL-17F, has shown clinical improvements in joint and skin outcomes and a favorable safety profile in patients (pts) with active psoriatic arthritis (PsA).1 Here we report the impact of BKZ treatment over 48 weeks on two patient-reported outcome (PRO) measures: Health Assessment Questionnaire Disability Index (HAQ-DI) and Psoriatic Arthritis Impact of Disease-9 (PsAID-9). The PsAID-9 is a questionnaire specifically developed to assess the impact of PsA on pts’ lives.2, 3 We also examine the association between achieving high disease control states (very low disease activity [VLDA], minimal disease activity [MDA] or Disease Activity in PSoriatic Arthritis [DAPSA] remission) and PsAID-9 score.

Methods: In this phase 2b dose-ranging study (BE ACTIVE; NCT02969525), PsA pts received BKZ or placebo.1 Here we report improvements in PROs over 48 weeks using the proportion of pts who achieved a Minimal Clinically Important Difference (MCID) in the functional score HAQ-DI (≥0.35 decrease from baseline). We also show the rate of pts reporting a PsAID-9 Patient Acceptable Symptom State (PASS), which for the PsAID-9 has been proposed as a score ≤4,2 and examine the association of VLDA/MDA (binary disease control states) or DAPSA (where remission is 0–4, low: 5–14, moderate: 15–28, and high disease activity is >28) with PsAID-9 score at Wk 12. The Full Analysis Set (FAS) is used up to and including Wk 12; the Dose-Blind Set (DBS) is used from Wk 12 to Wk 48.

Results: Across 206 randomized pts at baseline, 66.5% had psoriasis body surface area (BSA) ≥3%, 18.9% had prior tumor necrosis factor inhibitor (TNFi) exposure, and 63.6% received concomitant methotrexate. Mean baseline HAQ-DI scores were comparable across all treatment arms (including placebo), ranging from 0.9–1.0; PsAID‑9 scores ranged from 4.3–4.8. The proportion of pts achieving HAQ-DI MCID for BKZ 160 mg, 160 mg plus loading dose (LD), and 320 mg treatment arms was 47.5–58.5% across Wks 12, 24 and 48 (Figure 1a). Additionally, more than 75% of pts receiving BKZ 160/160 LD/320 mg achieved PsAID-9 PASS across Weeks 12, 24 and 48 (Figure 1b). Furthermore, a substantial proportion of pts within these BKZ treatment arms also achieved VLDA, MDA and/or DAPSA remission at Wk 12; this generally increased through to Wk 24 and 48 (Table). PsAID-9 score at Wk 12 was consistently lower for pts with VLDA/MDA or in DAPSA remission (Figure 2).

Conclusion: This patient population with active PsA demonstrated rapid and sustained improvements in patient-reported physical function and psychological wellbeing over 48 weeks of BKZ treatment. Achievement of VLDA/MDA or DAPSA remission was associated with lower mean PsAID-9 scores, reinforcing evidence that achievement of higher disease control in pts with PsA is important for improved quality of life.

References: 1. Ritchlin C. Lancet 2020;395:427–40; 2. Gossec L. Ann Rheum Dis 2014;73:1012–9; 3. Johnson K. Semin Arthritis Rheum 2019;49:241–5.


Disclosure: L. Gossec, Sandoz, 1, AbbVie, 5, 8, Amgen Inc., 5, 8, Biogen, 5, 8, Janssen, 5, 8, Celgene, 5, 8, Eli Lilly, 1, 5, 8, Novartis, 5, 8, Pfizer, 1, 5, 8, UCB Pharma, 5, 8, Sanofi, 5, 8; P. Mease, Amgen, 2, 5, 8, Bristol-Myers Squibb, 2, 5, Novartis, 2, 5, 8, Pfizer Inc, 2, 5, 8, Sun, 2, 5, UCB, 2, 5, 8, AbbVie, 2, 5, 8, Gilead, 2, 5, Janssen, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, GlaxoSmithKline, 5; A. Gottlieb, Janssen, 2, 5, Incyte, 2, 5, Novartis, 2, 5, 8, Xbiotech, 2, 9, Boehringer Ingelheim, 2, 5, UCB Pharma, 2, 5, 8, Beiersdorf, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, Sun Pharma, 2, 5, Leo Pharma, 5, Avotres Therapeutics, 5; D. Assudani, UCB Pharma, 3; J. Coarse, UCB Pharma, 3; B. Ink, UCB Pharma, 3; L. Coates, AbbVie, 2, 5, 8, Celgene, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Amgen Inc., 5, 8, Gilead, 5, 8, Janssen, 5, 8, UCB Pharma, 5, 8, Eli Lilly, 2, 5, 8, Biogen, 8, Medac, 8, Boehringer Ingelheim, 5, MSD, 5.

To cite this abstract in AMA style:

Gossec L, Mease P, Gottlieb A, Assudani D, Coarse J, Ink B, Coates L. Bimekizumab Improves Patient-Reported Outcomes in Psoriatic Arthritis: 48-Week Results from a Phase 2b Study and Association Between Patient-Reported Outcomes and Disease Activity [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/bimekizumab-improves-patient-reported-outcomes-in-psoriatic-arthritis-48-week-results-from-a-phase-2b-study-and-association-between-patient-reported-outcomes-and-disease-activity/. Accessed May 17, 2022.
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