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Abstract Number: 0381

Efficacy of Tofacitinib on Dactylitis in Individual Digits in Patients with Active Psoriatic Arthritis

Ana-Maria Orbai1, Philip Mease2, Philip Helliwell3, Oliver FitzGerald4, Mohamed Bedaiwi5, Dona Fleishaker6, Rajiv Mundayat6 and Pamela Young7, 1Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 2Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, 5Division of Rheumatology, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia, 6Pfizer Inc, Groton, CT, 7Pfizer Inc, Collegeville, PA

Meeting: ACR Convergence 2020

Keywords: Inflammation, Outcome measures, Psoriatic arthritis

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Session Information

Date: Friday, November 6, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

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

Background/Purpose: Dactylitis, a hallmark of psoriatic arthritis (PsA), is a uniformly diffuse and sometimes painful swelling of the fingers and/or toes.1 Up to 50% of patients (pts) with PsA may experience dactylitis;1,2 as such, dactylitis is an accepted domain of PsA that should be considered in treatment decisions.3 In PsA, dactylitis typically involves feet more than hands; dactylitic joints more frequently have erosive damage, compared with non-dactylitic joints.2 There remains a need for effective therapies to treat dactylitis in pts with PsA. Improvements in dactylitis have been associated with tofacitinib, an oral Janus kinase inhibitor for the treatment of PsA.4,5 Here, we assessed the effect of tofacitinib on dactylitis by location (hands/feet) and individual digit involvement in pts with PsA.

Methods: These post hoc analyses used data pooled from two Phase 3 studies (12-month OPAL Broaden [NCT01877668];5 6-month OPAL Beyond [NCT01882439]4) in pts with active PsA treated with tofacitinib 5 mg twice daily (BID; approved dose; to Month [M]6), tofacitinib 10 mg BID (to M6), or placebo (PBO; to M3); pts were treated continuously with a single conventional synthetic DMARD. Pts were categorized by the presence of dactylitis at baseline (BL) in the hands and/or feet. Endpoints included change from BL (CFB) in Dactylitis Severity Score (DSS),6 the number of dactylitic digits, and the proportion of pts with dactylitis in individual digits at M1, M3, and M6. Descriptive statistics were generated by visit and treatment arm.

Results: Data were pooled from 373 pts with DSS > 0 at BL. BL characteristics were similar across dactylitis groups, except pts with dactylitis in both hands and feet had higher DSS at BL, compared to those with dactylitis in hands only or feet only, likely due to having more dactylitic digits (Table). Regardless of location, pts treated with tofacitinib had cumulative improvements from BL to M6 in DSS (Figure 1a) and in the number of dactylitic digits (Figure 1b); improvements were greater at M1 and M3, compared with PBO. Pts treated with tofacitinib 10 mg BID typically had numerically greater improvements in DSS, compared with pts treated with tofacitinib 5 mg BID (Figure 1a). Most pts treated with tofacitinib experienced improvement of dactylitis across all fingers and toes (Figure 2); mean dactylitis presence was ≤ 15% at M6 in pts treated with tofacitinib for all digits. Generally, at M1 and M3, fewer pts treated with tofacitinib had dactylitis in any digit, compared with PBO (Figure 2).

Conclusion: Among pts with pre-existing dactylitis, treatment with tofacitinib resulted in improvements in dactylitis in hands, feet, or both, and in all digits as early as M1, and up to M6.

  1. Kaeley GS et al. Semin Arthritis Rheum 2018; 48: 263-273.
  2. Brockbank JE et al. Ann Rheum Dis 2005; 64: 188-190.
  3. Coates LC et al. Arthritis Rheumatol 2016; 68: 1060-1071.
  4. Gladman D et al. N Engl J Med 2017; 377: 1525-1536.
  5. Mease P et al. N Engl J Med 2017; 377: 1537-1550.
  6. Helliwell PS et al. J Rheumatol 2005; 32: 1745-1750.

Acknowledgments: Study sponsored by Pfizer Inc. Medical writing support was provided by Eric Comeau, PhD, CMC Connect, and funded by Pfizer Inc.


Disclosure: A. Orbai, Eli Lilly, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer Inc, 5, UCB, 5, AbbVie, 2, Celgene, 2, Horizon, 2; 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; P. Helliwell, AbbVie, 2, 8, Janssen, 2, Pfizer Inc, 8, Celgene, 8, Galapagos, 8, Amgen, 8, Novartis, 2, UCB, 8; O. FitzGerald, AbbVie Inc., 2, 5, Amgen, 2, 5, Bristol Myers Squibb, 2, 5, Celgene, 2, 5, Janssen, 2, 5, Eli Llilly, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, UCB, 2, 5; M. Bedaiwi, AbbVie, 8, Pfizer Inc, 8; D. Fleishaker, Pfizer Inc, 1, 3; R. Mundayat, Pfizer Inc, 1, 3; P. Young, Pfizer Inc, 1, 3.

To cite this abstract in AMA style:

Orbai A, Mease P, Helliwell P, FitzGerald O, Bedaiwi M, Fleishaker D, Mundayat R, Young P. Efficacy of Tofacitinib on Dactylitis in Individual Digits in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-tofacitinib-on-dactylitis-in-individual-digits-in-patients-with-active-psoriatic-arthritis/. Accessed .
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