17/10/2022, 12:09 Efficacy of Upadacitinib in Patients with Psoriatic Arthritis Stratified by Number of Prior Biologic Disease-modifying Anti-rheumatic Drugs

difying Anti-rheumatic Drugs - ACR Meeting Abstracts

ABSTRACT NUMBER: 1356

Efficacy of Upadacitinib in Patients with Psoriatic Arthritis

Stratified by Number of Prior Biologic Disease-modifying
Anti-rheumatic Drugs
Philip Mease1, Apinya Lertratanakul2, Bruce Strober3, Shigeyoshi Tsuji4, Pascal Richette5, Charlie
Lovan6, Dai Feng2, Jaclyn K Anderson2 and Filip Van den Bosch7, 1Seattle Rheumatology Associates,
P.L.L.C., Seattle, WA, 2AbbVie Inc., North Chicago, IL, 3Yale University School of Medicine and Central
Connecticut Dermatology, New Haven, 4Department of Orthopaedics/Rheumatology, National
Hospital Organization, Osaka Minami Medical Center, Osaka, Japan, 5Department of Rheumatology,
Lariboisière Hospital, Paris, France, 6AbbVie Inc., North Chicago, 7Ghent University Hospital, Ghent,
Belgium
Meeting: ACR Convergence 2020
Keywords: Psoriatic arthritis

SESSION INFORMATION
Date: Sunday, November 8, 2020 Session Type: Poster Session C
Session Title: Spondyloarthritis Including Session Time: 9:00AM-11:00AM
Psoriatic Arthritis – Treatment Poster III

Background/Purpose: Upadacitinib (UPA) has shown efficacy and safety in patients (pts) with active
PsA in the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials.1,2 Historically efficacy has been
lower with second- and third-line therapy compared with first-line anti-TNF therapy in PsA;3,4
however, clinical trial data that describe efficacy in pts who have had an inadequate response (IR) to
multiple biologic DMARDs (bDMARDs) are limited. This analysis assessed the effects of prior bDMARD
failure on UPA efficacy in the SELECT-PsA 2 trial.

Methods: The SELECT-PsA 2 study enrolled pts with prior IR or intolerance to ≥1 bDMARD (N=642).
Pts were randomized to placebo (PBO), UPA 15 mg once daily (QD, UPA15), or UPA 30 mg QD
https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/ 1/4
17/10/2022, 12:09 Efficacy of Upadacitinib in Patients with Psoriatic Arthritis Stratified by Number of Prior Biologic Disease-modifying Anti-rheumatic Drugs - ACR Meeting Abstracts

(UPA30). Stable background treatment of ≤2 non-bDMARDs was permitted; background therapy was
not required. Only the pts who had IR to ≥1 bDMARD were included in this analysis; pts were
subgrouped based on the number of bDMARDs failed prior to enrollment (1, 2, or ≥3). This analysis
includes assessment of proportion of pts achieving ACR20/50/70, and change in HAQ-DI, FACIT-
Fatigue, and SF-36 Physical Component Summary at Wk 12; static Investigator Global Assessment of
Psoriasis of 0 or 1 and at least a 2-point improvement from baseline, PASI75, and change in Self-
Assessment of Psoriasis Symptoms at Wk 16; and proportion of pts achieving minimal disease activity
(MDA) at Wk 24. Non-responder imputation was used for binary endpoints. Mixed-effects model for
repeated measures was used for continuous endpoints. Point estimates and 95% confidence
intervals (CIs) of the PBO subtracted treatment effect were calculated.

Results: 641 pts were randomized and received study drug; 92% were bDMARD-IR: 391 (61%) of pts
failed 1 bDMARD, 116 (18%) failed 2 bDMARDs, and 83 (13%) failed ≥3 bDMARDs.
In the overall study population, UPA15 and UPA30 demonstrated superiority vs placebo for all
endpoints evaluated. In this post hoc analysis, the PBO subtracted treatment effect demonstrates
generally consistent efficacy as compared to the overall study population for UPA15 and UPA30
across efficacy endpoints in the subgroups of pts with IR to 1, 2, or ≥3 prior bDMARDs (Figure). Due
to limited sample sizes for pts with IR to >1 bDMARD and the pt subsets analyzed for psoriasis-
related endpoints, results should be interpreted with caution.

Conclusion: Upadacitinib demonstrated consistent efficacy in treating clinical manifestations of PsA

including musculoskeletal symptoms, psoriasis, physical function, fatigue, and quality of life in pts
with IR to 1 or multiple prior bDMARDs. In addition, comprehensive disease control as measured by
MDA, was generally consistently achieved with upadacitinib regardless of number of prior bDMARDs
tried.

References
1. McInnes IB, et al. Ann Rheum Dis, 2020; 79:12.
2. Genovese MC, et al. Ann Rheum Dis, 2020; 79:139.
3. Costa L, et al. Drugs R D. 2017;17:509‐522.
4. Reddy SM, et al. 2016;35:2955‐2966.

https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/ 2/4
17/10/2022, 12:09 Efficacy of Upadacitinib in Patients with Psoriatic Arthritis Stratified by Number of Prior Biologic Disease-modifying Anti-rheumatic Drugs - ACR Meeting Abstracts

Disclosure: 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. Lertratanakul, AbbVie Inc., 1, 3; B. Strober, AbbVie Inc., 1, 2, Amgen, 1, 2, Eli
Lilly, 1, 2, Janssen, 1, 2, Ortho Dermatologics, 1, 2, Corrona Psoriasis Registry, 1, Almirall, 1, Arcutis, 1,
Arena, 1, Aristea, 1, Boehringer Ingelheim, 1, Bristol Myers Squibb, 1, Celgene, 1, Dermavant, 1,
Dermira, 1, Leo, 1, Meiji Seika Pharma, 1, Novartis, 1, Pfizer, 1, GlaxoSmithKline, 1, UCB Pharma, 1,
Sun Pharma, 1, Regeneron, 1, Sanofi-Genzyme, 1, Journal of Psoriasis and Psoriatic Arthritis, 1,
Dermavant, AbbVie, Corrona Psoriasis Registry, Dermira, Cara, Novartis, 1; S. Tsuji, AbbVie Inc., 1,
Asahi Kasei, 1, Chugai, 1, Daiichi Sankyo, 1, Eli Lilly, 1, Eisai, 1, Mitsubishi Tanabe, 1, Celgene, 1,
Novartis Pharma K.K., 1; P. Richette, AbbVie Inc., 1, Biogen, 1, Janssen, 1, BMS, 1, Roche, 1, Pfizer, 1,
Amgen, 1, Sanofi-Aventis, 1, UCB, 1, Lilly, 1, Novartis, 1, Celgene, 1; C. Lovan, AbbVie Inc., 1, 3; D.
Feng, AbbVie Inc., 1, 2; J. Anderson, AbbVie Inc., 1, 3, 4; F. Van den Bosch, AbbVie, 5, 8, Celgene, 5, 8,
Eli Lilly, 5, 8, Galapagos, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Gilead, 5, Merck, 5, 8.

To cite this abstract in AMA style:

Mease P, Lertratanakul A, Strober B, Tsuji S, Richette P, Lovan C, Feng D, Anderson J, Van den
Bosch F. Efficacy of Upadacitinib in Patients with Psoriatic Arthritis Stratified by Number of Prior
https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/ 3/4
17/10/2022, 12:09 Efficacy of Upadacitinib in Patients with Psoriatic Arthritis Stratified by Number of Prior Biologic Disease-modifying Anti-rheumatic Drugs - ACR Meeting Abstracts

Biologic Disease-modifying Anti-rheumatic Drugs [abstract]. Arthritis Rheumatol. 2020; 72 (suppl

10).
https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-
stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/. Accessed
October 17, 2022.

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-

psoriatic-arthritis-stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/

https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-stratified-by-number-of-prior-biologic-disease-modifying-anti-rheumatic-drugs/ 4/4