Efficacy

PSORIATIC ARTHRITIS

SELECT-PsA 1

Significantly more patients achieved ACR20 with RINVOQ vs placebo at Week 12^1,2

SELECT-PsA 1: ACR20 response rates at Week 12 (NRI)^1,2

In patients with active PsA and an inadequate response to non-biologic DMARDs, RINVOQ significantly improved joint symptoms vs placebo for ACR20 at Week 12^1,2

SELECT-PsA 1: ACR20/50/70 response rates at Week 12 (NRI)^1,2

ACR20 for RINVOQ vs placebo at Week 12 was a primary, multiplicity-controlled endpoint.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.

ACR20/50/70: American College of Rheumatology 20%/50%/70% improvement in both tender and swollen joint counts plus three of the following patient assessments of pain global disease activity and physical function physician global assessment of disease activity and acute phase reactant (high sensitivity C-reactive protein).

*p<0.001 vs placebo, comparison adjusted for multiplicity. ^†p<0.001 vs adalimumab for non-inferiority, comparison adjusted for multiplicity. ^‡Nominal p<0.001 vs placebo, comparison not adjusted for multiplicity.

SELECT-PsA 1: over time (NRI)²

SELECT-PsA 1: ACR20 response rates (NRI)^1-3

*p≤0.001 vs placebo, statistically significant in the multiplicity-controlled analysis.

^†p≤0.001 vs adalimumab for non-inferiority, statistically significant in the multiplicity-controlled analysis.

^‡Nominal p≤0.001 vs placebo.³#Nominal p≤0.05 vs adalimumab.³ ^§Not significant (nominal p=0.06) vs adalimumab.³

Nominal p-values denote data not controlled for multiplicity. No clinical inferences can be drawn.

Superiority vs adalimumab in ACR20 at Week 12 could not be demonstrated.^1,3At Week 24, all patients randomised to placebo were switched to RINVOQ 15 mg or 30 mg QD in a blinded manner. The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.

ACR20/50/70: American College of Rheumatology 20%/50%/70% improvement in both tender and swollen joint counts plus three of the following patient assessments of pain global disease activity and physical function physician global assessment of disease activity and acute phase reactant (high sensitivity C-reactive protein).

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified but not controlled for multiplicity. Nominal p-values are provided where available. Treatment differences could represent chance findings. No clinical conclusions can be made from these comparisons. Missing data were handled using NRI.

SELECT-PsA 1: ACR50 response rates (NRI)^1-3

^‡Nominal p≤0.001 vs placebo.³ ^#Nominal p≤0.05 vs adalimumab.³ Nominal p-values denote data not controlled for multiplicity. No clinical inferences can be drawn.

At Week 24, all patients randomised to placebo were switched to RINVOQ 15 mg or 30 mg QD in a blinded manner. The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose. Primary endpoint was the proportion of patients achieving ACR20 response with RINVOQ vs placebo at Week 12. ACR50 for RINVOQ vs placebo at Week 12 was an additional key secondary endpoint, not multiplicity-controlled. Comparison vs adalimumab was not prespecified.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Missing data were handled using NRI.

SELECT-PsA 1: ACR70 response rates (NRI)^1-3

^‡Nominal p≤0.001 vs placebo.³ ^#Nominal p≤0.05 vs adalimumab.³Nominal p-values denote data not controlled for multiplicity. No clinical inferences can be drawn.

At Week 24, all patients randomised to placebo were switched to RINVOQ 15 mg or 30 mg QD in a blinded manner. The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose. Primary endpoint was the proportion of patients achieving ACR20 response with RINVOQ vs placebo at Week 12. ACR70 for RINVOQ vs placebo at Week 12 was an additional key secondary endpoint, not multiplicity-controlled. Comparison vs adalimumab was not prespecified.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Missing data were handled using NRI.

Graphs adapted from McInnes et al. 2020

In patients with active PsA and an inadequate response to non-biologic DMARDs, RINVOQ demonstrated significant inhibition of joint damage vs placebo at Week 24

SELECT-PsA 1: Inhibition of structural joint damage progression at Week 24 (linear extrapolation)^1,2

Proportion of patients with no radiographic progression (mTSS change ≤0.5) was higher with RINVOQ vs placebo at Week 24 (96% vs 92%, nominal P≤0.05) and at Week 56† - (97% vs 89%, nominal p≤0.001)^1,5

*p≤0.001 vs placebo, statistically significant in multiplicity-controlled analysis. ^†All patients on placebo switched to RINVOQ at Week 24, all placebo data at Week 56 were derived using linear extrapolation. Nominal p-value denotes data not controlled for multiplicity. No clinical inferences can be drawn.

PsA Efficacy: Efficacy across key PsA manifestations

SELECT-PsA 1: PASI75 RESPONSE AT WEEK 16 (NRI)^1,2

For subjects with ≥3% BSA psoriasis at baseline (n=211, 211, and 214, respectively, for placebo, adalimumab, and RINVOQ).

*p≤0.001 vs placebo, statistically significant in the multiplicity-controlled analysis.
Subjects rescued at Week 16 were imputed as non-responders in the resolution of enthesitis and dactylitis at Week 24.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.

RESOLUTION OF ENTHESIS (LEI=0) at Week 24^1,2

For subjects with baseline presence of enthesitis (LEI>0). (n=241, 265 and 270 respectively, for placebo, adalimumab, and RINVOQ)

*p≤0.001 vs placebo, statistically significant in the multiplicity-controlled analysis.
Subjects rescued at Week 16 were imputed as non-responders in the resolution of enthesitis and dactylitis at Week 24.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.

Achievement of BASDAI50 at Week 24.^4,5

Pre-specified endpoint, statistical analysis not controlled for multiplicity. For subjects with baseline presence of psoriatic spondylitis.

RESOLUTION OF DACTYLITIS (LDI=0) at Week 24^1,2

*Nominal p≤0.001 vs placebo, not multiplicity controlled.

#RINVOQ 15 mg did not meet superiority vs adalimumab for ACR20 response, thus statistical significance vs placebo regarding proportion of patients achieving resolution of dactylitis could not be tested under the hierarchical analysis plan. Subjects rescued at Week 16 were imputed as non-responders in the resolution of enthesitis and dactylitis at Week 24.

DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity with nominal p-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders.

Significantly more patients treated with RINVOQ achieved minimal disease activity vs placebo at Week 24.^1,2,6

SELECT-PsA 1: Minimal disease activity at Week 24 (NRI)^2,6

*p≤0.001 vs placebo, comparison adjusted for multiplicity. Subjects rescued at Week 16 were imputed as non-responders in the MDA analysis. Minimal disease activity with RINVOQ vs placebo at Week 24 was a key ranked secondary, multiplicity-controlled endpoint. Non-responder imputation: Patients dropping out of the study for any reason were considered non-responders

^†Minimal Disease Activity is achieved when meeting 5 of 7 criteria⁷

Tender joint count ≤1
Swollen joint count ≤1
PASI ≤1 or BSA-PsO ≤3%
Patient pain NRS ≤1.5
Patient Global Disease Activity NRS ≤2
HAQ-DI ≤0.5
Tender entheseal points (LEI) ≤1

SELECT-PsA 1: A Phase 3 randomised, double-blind study assessing the efficacy and safety of RINVOQ, compared to placebo and adalimumab in PsA patients with an inadequate response or intolerance to at least one non-biologic DMARD.²

The approved dose of RINVOQ is 15mg QD. Upadacitinib 30mg QD is not an approved dose.

All subjects received x-rays of hands and feet at screening, Week 24, Week 56, Week 104, and Week 152. At Week 16, rescue therapy was offered to subjects classified as non-responders (defined as not achieving at least 20% improvement in TJC and SJC at both Week 12 and Week 16). At Week 24, all placebo subjects were switched to RINVOQ 15mg OD or upadacitinib 30mg OD (1:1 ratio) regardless of response.

Endpoints:

Primary endpoint: ACR20 response at Week 12 for RINVOQ vs placebo

Key secondary endpoints:

Statistically significantly greater improvement with RINVOQ vs placebo in:

mTSS at Week 24
Resolution of enthesitis at Week 24
PASI75 response at Week 16
sIGA 0/1 and >2 point improvement at Week 16
MDA at week 24
HAQ-DI at Week 12
SF-36 PCS at Week 12
FACIT-F at Week 12

Graph adapted from McInnes et al. 2020

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Abbreviations

ACR20/50/70: American College of Rheumatology 20%/50%/70% improvement score; FACIT-F: Functional Assessment of Chronic Illness Therapy – Fatigue; MDA: Mininal Disease Activity, HAQ-DI: Health Assessment Questionnaire – Disability Index; mTSS: modified Total Sharp Score; PASI 75: Psoriasis Area Severity Index 75% improvement; SF-36 PCS: Short Form (36) Health Survey (SF-36) Physical Component Summary; sIGA: Static Investigator's Global Assessment.

References

RINVOQ (upadacitinib) SmPC.
McInnes IB, Anderson J, Magrey M, et al. Efficacy and safety of upadacitinib versus placebo and adalimumab in patients with active psoriatic arthritis and inadequate response to non-biologic disease-modifying antirheumatic drugs (SELECT-PsA 1): a double blind, randomized controlled phase 3 trial. Presented at: European Congress of Rheumatology Annual Meeting; June 3-6, 2020. Oral Presentation LB0001.
AbbVie Data on File. ABVRRTI71394.
AbbVie Data on File. ABVRRTI71397.
Deodhar A, Ranza R, Ganz F, et al. Efficacy and safety of upadacitinib in patients with psoriatic arthritis and axial involvement [abstract]. Arthritis Rheumatol. 2020;72(suppl. 10):1372.
Coates LC et al. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis 2010;69:48–53. doi:10.1136/ard.2008.102053.

RINVOQ PRESCRIBING INFORMATION

ADALIMUMAB PRESCRIBING INFORMATION

UK-UPAD-210141. Date of preparation: May 2021.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com

SELECT-PsA 1

Significantly more patients achieved ACR20 with RINVOQ vs placebo at Week 12^1,2