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

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

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

Older woman in a harness, ziplining

Durable
remission
even without mtx2,3

RINVOQ achieved DAS28-CRP<2.6* (ranked secondary endpoint) at Week 12 or 14, with durable remission rates up to 84 weeks. Remission was also evaluated using additional measures.1,3-9

*Does not mean drug-free remission or complete absence of disease activity

CRP=C-reactive protein; DAS28=disease activity score 28 joints;
IR=intolerance or inadequate response; MTX=methotrexate

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:1,5
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-MONOTHERAPY: Primary endpoint was ACR20 response at Week 14 MTX-IR

*P<0.0001 RINVOQ vs MTX

SELECT‑MONOTHERAPY (Study RA-II) Study Design Intro:1,8 
14‑week, randomized, double‑blind, active comparator‑controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX. The primary endpoint was ACR20 response at Week 14.

Remission data across measures
even without mtx1,5-9

SELECT‑COMPARE:
Clinical Remission Data (Week 12)

~30% of RINVOQ + MTX patients achieved Remission (DAS28‑CRP<2.6) at 12 Weeks

SELECT‑MONOTHERAPY:
Clinical Remission Data (Week 14)

~30% of RINVOQ patients achieved
Remission (DAS28‑CRP<2.6) at 14 Weeks

SELECT-MONOTHERAPY: Clinical Remission Data SELECT-MONOTHERAPY: Clinical Remission Data SELECT-MONOTHERAPY: Clinical Remission Data
Educational Speaker Program Webinar

SELECT‑MONOTHERAPY

Watch as Professor Paul Emery discusses RINVOQ efficacy and safety information from the SELECT‑MONOTHERAPY study.

SELECT-MONOTHERAPY Study Design

Video 1/4

Background information on a Phase 3 clinical trial program for RINVOQ as monotherapy.

SELECT-MONOTHERAPY Results

Video 2/4

A showcase of the results of the SELECT‑MONOTHERAPY study.

SELECT-MONOTHERAPY Safety Data

Video 3/4

A look at the safety data for the SELECT‑MONOTHERAPY study.

SELECT MONOTHERAPY Highlights

Video 4/4

Featuring the highlights of the SELECT‑MONOTHERAPY study and important safety information.

Switching from MTX to UPADAC monotherapy: See the results

 

Professor Paul Emery, Rheumatologist reviews SELECT-MONOTHERAPY, a phase 3 trial comparing MTX patients who switched to UPADAC vs those who remained on MTX.

Durable remission
rates even
without
MTX2-6,8,9,11-13

SELECT‑COMPARE:
Clinical Remission Data (Up to Week 72)
DAS28-CRP<2.6

41% of RINVOQ + MTX patients
achieved remission at 72 weeks

SELECT‑MONOTHERAPY:
Clinical Remission Data (Up to Week 84)
DAS28-CRP<2.6

46% of RINVOQ patients
achieved remission at 84 weeks

SELECT-MONOTHERAPY: Clinical Remission Data SELECT-MONOTHERAPY: Clinical Remission Data SELECT-MONOTHERAPY: Clinical Remission Data

RINVOQ SAFETY DATA

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

IMPORTANT SAFETY INFORMATION & INDICATION1

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 one or more TNF blockers.

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.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Fleischmann RM, Genovese MC, Enejosa JV, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019;78(11):1454‑1462.
  3. Smolen J, Emery P, Rigby W, et al. Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks from the SELECT‑MONOTHERAPY Study. Poster presented at: The European Congress of Rheumatology, 3-6 June 2020, E-Congress.
  4. Fleischmann R, Song I-H, Enejosa J, et al. Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients With Rheumatoid Arthritis: Results at 72 Weeks From the SELECT-COMPARE Study. Poster presented at: The European Congress of Rheumatology, 3-6 June 2020, E‑Congress.
  5. Fleischmann R, Pangan AL, Song I‑H, et al. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
  6. Fleischmann R, Pangan AL, Song I-H, et al. Supplement - Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
  7. Data on File. ABVRRTI68651.
  8. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT‑MONOTHERAPY): a randomised, placebo‑controlled, double‑blind phase 3 study. Lancet. 2019;393(10188):2303‑2311.
  9. Smolen JS, Pangan AL, Emery P, et al. Supplement - Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT‑MONOTHERAPY): a randomised, placebo‑controlled, double‑blind phase 3 study. Lancet. 2019;393(10188):2303‑2311.
  10. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
  11. Data on File. ABVRRTI70898.
  12. Data on File. ABVRRTI68439.
  13. Data on File. ABVRRTI70899.

INDICATION & LIMITATION OF USE1

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
INFORMATION & INDICATION1

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 immunosuppressants

INDICATION & LIMITATION OF USE1

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
INFORMATION & INDICATION1

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 immunosuppressants

IMPORTANT SAFETY INFORMATION & INDICATION1

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 one or more TNF blockers.

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.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS