Benzinga | Nov 9, 2021 11:46AM EST

AbbVie Presents New Efficacy Data On Upadacitinib (RINVOQ) In People With Active Psoriatic Arthritis And Axial Involvement At ACR Convergence 2021

AbbVie (NYSE:ABBV) today announced results from new post-hoc analyses from the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials assessing the efficacy of upadacitinib (RINVOQ(r)) on axial symptoms in adult patients with active psoriatic arthritis (PsA) and axial involvement. The analysis showed that patients with active PsA demonstrated numerically greater clinical responses related to their axial involvement with upadacitinib (15 mg, once daily) compared to placebo at week 24 across both studies and consistently numerically higher responses compared to HUMIRA(r) (adalimumab) at week 24 in SELECT-PsA 1.1

Axial involvement was defined by investigator assessment and patient-reported-outcome-based criteria (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ?4 and BASDAI Question 2 ?4 at baseline).1 These results will be featured at the American College of Rheumatology (ACR) Convergence 2021, in an oral presentation on Tuesday, Nov. 9, from 3:30-3:45 p.m. CT (Abstract #1945).

"These data further add to the body of evidence that support the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We remain committed to advancing research across our portfolio of therapies to help improve care for more people living with rheumatic diseases, including psoriatic arthritis."

At week 24, upadacitinib showed numerically greater responses than adalimumab across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints in SELECT-PsA 1.1 The proportion of patients achieving ASDAS clinically important improvement (CII) at week 24 was greater with upadacitinib (69.8%) versus adalimumab (54.1%, nominal P<0.05).1

Clinical Responses in Patients with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria at Week 24 from SELECT-PsA 1 and SELECT-PsA 21

Endpoint SELECT-PsA 1 SELECT-PsA 2

PBO UPA ADA PBO UPA

Overall BASDAIS: -2.05 -3.47&#x2A;&#x2A;&-2.98 -0.52 -2.48&#x2A;&#x2A;&(mean #x2A; #x2A; (n = (n = (n = change from 90) (n = 98) 78) 51) (n = 46) baseline)

Modified BASDAI (excl. -2.02 -3.38&#x2A;&#x2A;&-2.90 -0.46 -2.40&#x2A;&#x2A;& #x2A; #x2A; Q3)S: (mean (n = (n = (n = change 90) (n = 98) 78) 51) (n = 46) from baseline)

29.3 60.4&#x2A;&#x2A;&#47.1 3.1 29.8&#x2A;&#x2A;&#BASDAI50? (%) x2A; x2A; (n = (n = (n = 99) (n = 106) 85) 64) (n = 57)

ASDASS: (mean -0.81 -1.87&#x2A;&#x2A;&-1.57 -0.11 -1.37&#x2A;&#x2A;&change #x2A; #x2A; (n = (n = (n = from baseline) 89) (n = 98) 77) 50) (n = 46)

10.1 36.8&#x2A;&#x2A;&#29.4 0.0 24.6&#x2A;&#x2A;&#ASDAS ID?,? (%) x2A; x2A; (n = (n = (n = 99) (n = 106) 85) 64) (n = 57)

25.3 61.3&#x2A;&#x2A;&#50.6 4.7 43.9&#x2A;&#x2A;&#ASDAS LDA?,? (%) x2A; x2A; (n = (n = (n = 99) (n = 106) 85) 64) (n = 57)

12.1 47.2&#x2A;&#x2A;&#36.5 0.0 26.3&#x2A;&#x2A;&#ASDAS MI?,? (%) x2A; x2A; (n = (n = (n = 99) (n = 106) 85) 64) (n = 57)

31.3 69.8#&#x2A;&#x2A;&54.1 6.3 45.6&#x2A;&#x2A;&#ASDAS CII?,? (%) #x2A; x2A; (n = (n = (n = 99) (n = 106) 85) 64) (n = 57)

ADA, adalimumab; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI,Bath Ankylosing Spondylitis Disease Activity Index; CII, clinically importantimprovement; EOW, every other week; ID, inactive disease; LDA, low diseaseactivity; MI, major improvement; MMRM, mixed-effect model repeated measures;NRI, non-responder imputation; PBO, placebo; UPA, upadacitinib

&#x2A;&#x2A;&#x2A;P<0.001, UPA 15 mg vs PBO; #P<0.05, UPA 15 mg vs ADA;nominal P-values are presented and were not adjusted for multiple comparisons

?NRI analysis constructed using Cochran-Mantel-Haenszel test adjusting for themain stratification factor of current DMARD use (yes/no) was used for binaryendpoints

? ASDAS thresholds: ID <1.3; LDA <2.1; MI change from baseline ?2; CII changefrom baseline ?1.1

S: MMRM analysis with unstructured variance-covariance matrix, includingtreatment, visit, treatment-by-visit interaction, the stratification factorcurrent DMARD use (yes/no) as fixed factors and the continuous fixed covariateof baseline measurement was used for continuous endpoints

"People with psoriatic arthritis and axial involvement often face significant functional challenges," said Iain McInnes, professor of medicine and Versus Arthritis professor of rheumatology at University of Glasgow, U.K. "These data underscore the potential for upadacitinib to help more patients take control of their disease, including those impacted by axial symptoms."

Findings from the post-hoc analysis are consistent with previous data based on investigator assessment alone.1

Across SELECT-PsA 1 and SELECT-PsA 2 studies, the published safety profile of RINVOQ was consistent with that observed in previously reported studies, with no new safety risks detected.2,3,4

As previously reported, in SELECT-PsA 1, through week 24, serious infections occurred in 1.2% of patients in the 15 mg RINVOQ group compared to 0.9% in the placebo group and 0.7% in the HUMIRA group.2 There were no cases of adjudicated venous thromboembolic events (VTE) in the RINVOQ 15 mg group, two cases in the adalimumab group (0.5%) and one case in the placebo group (0.2%).2 No major adverse cardiovascular events (MACE) were reported in the RINVOQ 15 mg group.2 There was one MACE reported in the placebo group and two MACE reported in the HUMIRA group.2 Herpes zoster was reported in four cases in the 15 mg RINVOQ group (0.9%), three cases in the placebo group (0.7%) and no cases in the HUMIRA group.5 There were no deaths in the RINVOQ 15 mg group, one death in the placebo group (0.2%) and no deaths in the adalimumab group.2

As previously reported, for the SELECT-PsA 2 study, through week 24, serious infections occurred in 0.5% of patients in the RINVOQ 15 mg group compared to 0.5% in the placebo group.4 There was one pulmonary embolism reported in the 15 mg RINVOQ group and none in the placebo group.4 There was one non-fatal adjudicated major adverse cardiovascular event (MACE) in the 15 mg RINVOQ group (acute myocardial infarction) and no MACE in the placebo group.4 Herpes zoster was reported in three cases in the 15 mg RINVOQ group (1.4%) and in two cases in the placebo group (0.9%).6 One death was reported in a patient receiving placebo (motor vehicle accident).4

Use of upadacitinib in psoriatic arthritis is not approved in the U.S. and its safety and efficacy are currently under review by the U.S. Food and Drug Administration (FDA).

The ACR Convergence 2021 abstracts can be found here.