Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

For moderate to severe rheumatoid arthritis (RA) in adult MTX‑IR patients1

Power to help stop further joint damage with or without MTX Power to help stop further joint damage with or without MTX Power to help stop further joint damage with or without MTX

Achieved ranked secondary endpoint
of mean change from baseline in radiographic progression (ΔmTSS) at Week 26 or 24, with responses observed up to 96 weeks.2-5

RINVOQ is not indicated for MTX‑naïve patients


IR=intolerance or inadequate response; MTX=methotrexate; mTSS=modified total sharp score

Clinical Trial Overview

SELECT-COMPARE: Primary endpoint was ACR20 response at Week 12 MTX-IR

*P≤0.001 RINVOQ vs Placebo

SELECT‑COMPARE (Study RA‑IV) Study Design Intro:1,2
48‑week, randomized, double‑blind, active
comparator‑controlled study of 1629 adult patients with moderate to severe RA who had an inadequate response to MTX. The primary endpoint was ACR20 response at Week 12 vs Placebo. Prespecified blinded rescue protocol occurred at weeks 14, 18, 22, or 26.

SELECT-EARLY Study: primary endpoint was ACR50 response at week 12 MTX-naïve

*P≤0.001 RINVOQ vs MTX

RINVOQ is not indicated for MTX-naïve patients

SELECT‑EARLY (Study RA‑I) Study Design Intro:1,3
48‑week, randomized, double‑blind, active comparator‑controlled study of 947 adult patients with moderate to severe RA who were MTX-naïve. The primary endpoint was ACR50 response at Week 12. At Week 26, non‑responding patients were rescued according to prespecified criteria. 

Radiographic inhibition even without MTX Radiographic inhibition even without MTX Radiographic inhibition even without MTX

SELECT‑COMPARE: Radiographic Response: Week 26

SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26)

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

SELECT-COMPARE results are based on random coefficient model.b Data observed after rescue are not included in the analysis.

SELECT‑EARLY: Radiographic Response: Week 24

SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24)

RINVOQ is not indicated for MTX‑naïve patients

Please see HUMIRA full Prescribing Information.

Radiographic inhibition even without MTX Radiographic inhibition even without MTX Radiographic inhibition even without MTX

SELECT-COMPARE
Radiographic Response: mTSS

Subgroup Analysis (As Observed)

SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26) SELECT-COMPARE: Radiographic Response (Week 26)

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

Subgroup Analyses:5 Prespecified subgroup analyses include data for patients that were not rescued, had both baseline and follow-up X-rays, and were reported as observed (AO), without imputation for missing data.

SELECT-EARLY
Radiographic Response: mTSS

Subgroup Analysis (As Observed)

SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24) SELECT-EARLY: Radiographic Response (Week 24)

RINVOQ is not indicated for MTX‑naïve patients

SELECT-COMPARE: Radiographic Response - mTSS4,5
up to 96 Weeks
Subgroup Analysis (As Observed)

SELECT‑COMPARE was not designed to evaluate comparative effectiveness of radiographic outcomes vs HUMIRA + MTX. This presentation cannot be interpreted as evidence of superiority, non‑inferiority, or similarity of HUMIRA + MTX to RINVOQ + MTX or Placebo + MTX.

For change from baseline in mTSS least squares mean estimator was based on an ANCOVA model with treatment and prior bDMARD as fixed factor and baseline value as a covariate.5

Please see HUMIRA full Prescribing Information.

SELECT-EARLY: Radiographic Response - mTSS4,7
up to 96 Weeks
Subgroup Analysis (As Observed)

RINVOQ is not indicated for MTX‑naïve patients

For change from baseline in mTSS least squares mean estimator was based on an ANCOVA model with treatment and geographic region as fixed factor and baseline value as a covariate.5

SELECT‑EARLY

Watch as Dr. Stephen Hall discusses RINVOQ efficacy and safety information from the SELECT‑EARLY study.

SELECT-EARLY Study Design

Video 1/4

Background information on the Phase 3 clinical program for RINVOQ and study details for SELECT‑EARLY.

SELECT-EARLY Results

Video 2/4

A look at the primary endpoint and ranked secondary endpoint results of the SELECT‑EARLY study.

SELECT-EARLY Safety Data

Video 3/4

In this chapter, the SELECT-EARLY safety data including rates of adverse events are explored.

SELECT-EARLY Highlights

Video 4/4

A summary of the SELECT‑EARLY study and important safety information.

RINVOQ SAFETY DATA

Review the well-studied safety profile of RINVOQ,
including both short- and long-term analyses

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking