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

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

The first RA therapy
to demonstrate
superiority in
separate head-to-head trials against 2 biologics2,3

SELECT-COMPARE
(JAK inhibitor vs TNF inhibitor)

A study in MTX-IR patients:

  • RINVOQ + MTX vs HUMIRA® (adalimumab) + MTX

RINVOQ + MTX achieved superiority in its ranked secondary endpoints at Week 12 vs HUMIRA® (adalimumab) + MTX:

ACR50, HAQ-DI, and Pain Reduction

SELECT-CHOICE
(JAK inhibitor vs T-cell inhibitor)

A study in bDMARD-IR patients:

  • RINVOQ + csDMARDs vs ORENCIA® (abatacept) + csDMARDs

RINVOQ + csDMARDs achieved superiority in its ranked secondary endpoint at Week 12 vs ORENCIA® (abatacept) + csDMARDs:

DAS28-CRP<2.6

ACR=American College of Rheumatology; CRP=C-reactive protein; csDMARDs=conventional synthetic disease modifying anti‑rheumatic drugs; DAS28=disease activity score 28 joints; HAQ-DI=health assessment questionnaire disability index; IR=intolerance or inadequate response; JAK=janus kinase; MTX=methotrexate; TNF=tumor necrosis factor

Clinical Trial Overview

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

*P≤0.001 vs RINVOQ vs Placebo or MTX

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. Patients on background MTX were randomized to receive RINVOQ 15 mg once daily (n=651), placebo (n=651), or adalimumab 40 mg EOW (n=327). The primary endpoint was ACR20 response at Week 12 vs Placebo.

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

P<0.001 vs ORENCIA® (abatacept); Treatment difference for change in DAS28‑CRP from baseline was -0.52 (-0.69, -0.35).

SELECT‑CHOICE Study Design Intro:3,4 
24-week, double-blind, active comparator–controlled study of 612 adult patients with moderate to severe RA who had an inadequate response or intolerance to bDMARDs. Patients on stable csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=303) or weight‑based abatacept IV at 0, 2, and 4 weeks, and every 4 weeks thereafter (n=309). The primary endpoint was ΔDAS28‑CRP (noninferiority) at Week 12.

RINVOQ + MTX
vs a TNFi + MTX

Demonstrated superiority in ACR50,
HAQ-DI & pain reduction at week 122

RINVOQ + MTX vs HUMIRA (adalimumab) + MTX

SELECT-COMPARE:
Superiority Data

A study in MTX‑IR patients

15
29
45*†
-0.3
-0.5
-0.6§
-16
-26
-32∣∣
SELECT-COMPARE: ACR50, HAQ-DI, and PAIN SELECT-COMPARE: ACR50, HAQ-DI, and PAIN SELECT-COMPARE: ACR50, HAQ-DI, and PAIN
SELECT-COMPARE: Superiority Data Legend

P≤0.001 for RINVOQ + MTX vs Placebo + MTX; Analyses were not controlled for multiplicity; P‑values obtained through nominal statistical testing.

Signs and Symptoms, Physical Function & Pain Reduction

RINVOQ + MTX vs
HUMIRA (adalimumab) + MTX

SELECT-COMPARE:

DEMONSTRATED SUPERIORITY

IN ACR50 AT WEEK 122,5-10

A study in MTX‑IR patients

SELECT-COMPARE: ACR50 SELECT-COMPARE: ACR50 SELECT-COMPARE: ACR50
SELECT-COMPARE: Chart legend

Treatment groups are by initial randomization. Observations after rescue were handled using NRI (weeks 14-22) and LOCF (Week 26). For patients who discontinued at any time before or at Week 72, NRI was used.

P≤0.001 for RINVOQ + MTX vs Placebo + MTX; analysis was not controlled for multiplicity;
P-value obtained through nominal statistical testing.

Please see HUMIRA full Prescribing Information.

Please see HUMIRA full Prescribing Information.

SELECT-COMPARE:

DEMONSTRATED SUPERIORITY

in HAQ-DI AT WEEK 122,5-9,11

A study in MTX‑IR patients

SELECT-COMPARE: HAQ-DI SELECT-COMPARE: HAQ-DI SELECT-COMPARE: HAQ-DI
SELECT-COMPARE: Chart legend SELECT-COMPARE: Chart legend SELECT-COMPARE: Chart legend

Treatment groups are by initial randomization (ANCOVA). Observations after rescue treatment switch were imputed as LOCF.

Please see HUMIRA full Prescribing Information.

Please see HUMIRA full Prescribing Information.

SELECT-COMPARE:

DEMONSTRATED SUPERIORITY

in PAIN REDUCTION AT WEEK 122,5-9,12

In MTX-IR patients

SELECT-COMPARE: Pain Reduction SELECT-COMPARE: Pain Reduction SELECT-COMPARE: Pain Reduction
SELECT-COMPARE: Chart legend

Treatment groups are by initial randomization (ANCOVA). Observations after rescue treatment switch were imputed as LOCF.

P≤0.001 for RINVOQ + MTX vs Placebo + MTX; Analysis was not controlled for multiplicity;
P-value obtained through nominal statistical testing.

Please see HUMIRA full Prescribing Information.

Please see HUMIRA full Prescribing Information.

Educational Speaker Program Webinar

SELECT‑COMPARE

Watch as Dr. Roy Fleischmann discusses RINVOQ efficacy and safety information from the SELECT‑COMPARE study.

SELECT-COMPARE Study Design

Video 1/4

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

SELECT-COMPARE Results

Video 2/4

A look at the results of the SELECT‑COMPARE study.

SELECT-COMPARE Safety Data

Video 3/4

An overview of the SELECT‑COMPARE study safety data.

SELECT-COMPARE Highlights

Video 4/4

A summary of the SELECT‑COMPARE trial and important safety information.

RINVOQ + csDMARDs vs
a T‑Cell Inhibitor + csDMARDs

Demonstrated superiority
in
remission at week 123

DAS28-CRP<2.6* with RINVOQ + csDMARDs vs ORENCIA® (abatacept) + csDMARDs

SELECT-CHOICE: DAS28-CRP <2.6*

A study in bDMARD-IR patients

SELECT-CHOICE: DAS28-CRP<2.6*

A study in bDMARD-IR patients

SELECT-COMPARE: DAS28-CRP<2.6 RINVOQ + MTX vs Placebo + MTX at Week 12 SELECT-COMPARE: DAS28-CRP<2.6 RINVOQ + MTX vs Placebo + MTX at Week 12 SELECT-COMPARE: DAS28-CRP<2.6 RINVOQ + MTX vs Placebo + MTX at Week 12
SELECT‑CHOICE Study Legend

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

Starting at Week 12, patients who did not achieve ≥20% improvement in both TJC and SJC compared to baseline at 2 consecutive visits were to have background medications adjusted or added.

Treatment groups are by initial randomization (CMH) and missing data handling by NRI.

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 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

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 such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • 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 infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-RNQR-200725

Please see full Prescribing Information.

Please see full Prescribing Information.

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. 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.
  3. Rubbert-Roth A, Enejosa J, Pangan AL, et al. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. The New England Journal of Medicine. 2020,383(16):1511-1521. 
  4. Rubbert-Roth A, Enejosa J, Pangan AL, et al. Efficacy and Safety of Upadacitinib vs Abatacept in Patients with Active Rheumatoid Arthritis and Prior Inadequate Response or Intolerance to Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-CHOICE): A Double-Blind, Randomized Controlled Phase 3 Trial. Ann Rheum Dis 2020;79(Suppl 1):1011.
  5. 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.
  6. Fleischmann RM, Genovese MC, Enejosa JV, et al. Supplement - 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.
  7. 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.
  8. 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.
  9. Data on File. ABVRRTI68439.
  10. Data on File. ABVRRTI70894.
  11. Data on File. ABVRRTI70896.
  12. Data on File. ABVRRTI70897.

 

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 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

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 such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • 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 infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-RNQR-200725