P174 Upadacitinib response rates in patients with psoriatic arthritis enrolled in the SELECT-PsA-1 and SELECT-PsA-2 trials assessed according to modified PsARC
Authors: Coates Laura C , Garrood Toby , Gullick Nicola , Helliwell Philip , Kent Toby , Marks Jonathan , Tillett William , Kaur-Papadakis Daljit , Tahir Hasan , Haaren Stijn van , McInnes Iain 
Published: April 2021

Background/Aims 

The objective of this analysis was to describe the upadacitinib (UPA) response rates of patients with psoriatic arthritis (PsA) enrolled in the SELECT-PsA-1 and SELECT-PsA-2 randomised controlled trials according to modified Psoriatic Arthritis Response Criteria (PsARC). The UK National Institute for Health and Care Excellence recommends assessing PsA treatment responses using PsARC (advanced therapy-specific time points: after weeks [W] 12, 16 or 24).

Methods 

PsARC responses were assessed from W2 through W24 post-initiation for patients enrolled in SELECT-PsA-1 (upadacitinib 15 mg once-daily [UPA-15mg], placebo and adalimumab 40 mg every other week [ADA] treatment arms) and SELECT-PsA-2 (UPA-15mg and placebo treatment arms). PsARC responses were derived from tender joint count 68 (TJC), swollen joint count 66 (SJC), patient global self-assessment (PtGA) and physician global assessment (PGA) and analysed using non-responder imputation.

Results 

UPA-15mg PsARC response rates increased progressively from W2 through to W12 in SELECT-PsA-1 (78.3%) and SELECT-PsA-2 (70.6%; see Table). Despite relatively high placebo response rates, UPA-15mg response rates were statistically significantly higher than placebo at all assessments between W2 and W24 in SELECT-PsA-1 and SELECT-PsA-2 and were statistically significantly higher than ADA from W20 (SELECT-PsA-1; see Table). Baseline characteristics (including sex, PsA duration, body mass index, tobacco use, body surface area ≥3%, enthesitis and dactylitis) were generally balanced between W24 PsARC responders and non-responders in each SELECT-PsA-1 and SELECT-PsA-2 treatment arm. Differences in PsARC response rates at W24 for UPA-15mg versus placebo (pooled SELECT-PsA-1 and SELECT-PsA-2 data) and versus ADA (SELECT-PsA-1) were similar in patients stratified by baseline characteristics and in patients receiving UPA-15mg monotherapy versus combination therapy. By W12, UPA-15mg response rates for individual PsARC components (SJC and TJC: ≥30% improvement; PtGA and PGA: ≥20% improvement) ranged between 77.6%-89.5% in SELECT-PsA-1 and between 70.1%-82.5% in SELECT-PsA-2.

Conclusion 

PsARC responses greater than placebo were seen as early as W2, with stable response rates from W12 in both SELECT-PsA-1 and SELECT-PsA-2. Statistically significantly higher response rates versus ADA were observed by W20. Differences in W24 PsARC responses versus placebo and versus ADA were generally consistent across baseline characteristics and UPA-15mg mono/combination therapy. P174 Table 1:Modified PsARC response rates at W2 to W24 in SELECT-PsA-1 and SELECT-PsA-2 trialsStudy and week of assessmentTreatment armResponse rate % (95% CI)Response rate difference % (95% CI) UPA-placeboResponse rate difference % (95% CI) UPA-ADASELECT-PsA-1W2Placebo (n = 423)27.2 (22.9-31.4)14.8 (8.5-21.1)*−2.3 (−9.0-4.3)ADA (n = 429)44.3 (39.6-49.0)UPA-15mg (n = 429)42.0 (37.3-46.6)W12Placebo (n = 423)54.6 (49.9-59.4)23.7 (17.6-29.9)*2.8 (−2.8-8.4)ADA (n = 429)75.5 (71.5-79.6)UPA-15mg (n = 429)78.3 (74.4-82.2)W16Placebo (n = 423)55.1 (50.3-59.8)24.4 (18.3-30.5)*1.9 (−3.6-7.4)ADA (n = 429)77.6 (73.7-81.6)UPA-15mg (n = 429)79.5 (75.7-83.3)W20Placebo (n = 423)62.4 (57.8-67.0)21.3 (15.5-27.1)*6.3 (1.0-11.6)*ADA (n = 429)77.4 (73.4-81.3)UPA-15mg (n = 429)83.7 (80.2-87.2)W24Placebo (n = 423)59.3 (54.7-64.0)24.3 (18.5-30.2)*7.0 (1.7-12.3)*ADA (n = 429)76.7 (72.7-80.7)UPA-15mg (n = 429)83.7 (80.2-87.2)SELECT-PsA-2W2Placebo (n = 212)25.5 (19.6-31.3)22.4 (13.5-31.3)*-UPA-15mg (n = 211)47.9 (41.1-54.6)W12Placebo (n = 212)36.3 (29.8-42.8)34.3 (25.4-43.2)*-UPA-15mg (n = 211)70.6 (64.5-76.8)W16Placebo (n = 212)34.4 (28.0-40.8)31.4 (22.4-40.5)*-UPA-15mg (n = 211)65.9 (59.5-72.3)W20Placebo (n = 212)41.5 (34.9-48.1)28.6 (19.6-37.7)*-UPA-15mg (n = 211)70.1 (64.0-76.3)W24Placebo (n = 212)36.3 (29.8-42.8)31.9 (22.9-40.9)*-UPA-15mg (n = 211)68.2 (62.0-74.5)SELECT-PsA-1: randomised controlled trial assessing the safety and efficacy of UPA versus placebo versus ADA in patients with PsA and prior inadequate response or intolerance to ≥ 1 non-biologic disease-modifying antirheumatic drug (DMARD).SELECT-PsA2: randomised controlled trial assessing the safety and efficacy of UPA versus placebo in patients with PsA and prior inadequate response or intolerance to ≥ 1 biologic DMARD.95% confidence intervals (95% CI) for response rates calculated based on normal approximation to the binomial distribution.95% CI for response rate difference based on normal approximation.*Statistically significant at 0.05 level; nominal p values constructed using Cochran-Mantel-Haenszel test adjusting for current disease-modifying antirheumatic drug use (yes/no).

Disclosure 

L.C. Coates: Consultancies; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Honoraria; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Member of speakers’ bureau; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Grants/research support; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. T. Garrood: Consultancies; AbbVie, Pfizer and Gilead. Honoraria; AbbVie, Pfizer and Gilead. Grants/research support; AbbVie, Pfizer and Gilead. N. Gullick: Consultancies; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. Member of speakers’ bureau; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. Grants/research support; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. P. Helliwell: Consultancies; Eli Lilly. Other; fees for educational services from Pfizer, Novartis and Janssen. T. Kent: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. J. Marks: Honoraria; AbbVie, Gilead, Novartis, Pfizer and UCB for participation in advisory boards and to support educational activities unrelated to the publication. W. Tillett: Consultancies; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. Honoraria; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. Member of speakers’ bureau; AbbVie, Janssen and Celgene. Grants/research support; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. D. Kaur-Papadakis: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. H. Tahir: Consultancies; Fees for consultation or participation in advisory boards from AbbVie, Novartis, Pfizer, UCB, Eli-Lilly and Janssen. Other; Education Grants from Novartis and Pfizer. S. van Haaren: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. I. McInnes: Honoraria; Bristol-Myers Squibb, Celgene, Eli Lilly and Company, AbbVie, Gilead, Janssen, Novartis, Pfizer, and UCB. Grants/research support; Bristol-Myers Squibb, Celgene, Eli Lilly and Company, AbbVie, Gilead, Janssen, Novartis, Pfizer, and UCB.