HUMIRA® for HCPs
SkyRizi™ for HCPs
RINVOQ™ for HCPs

NOW APPROVED  For moderate to severe rheumatoid arthritis (RA) in adult MTX-IR patients.1

Safety data from a large registrational clinical program in RA Safety data from a large registrational clinical program in RA Safety data from a large registrational clinical program in RA
Well-studied safety profile. Five robust Phase 3 trials. Greater than 4500 patients evaluated. Greater than 3300 patient-years of exposure.

aSELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-EARLY, SELECT-NEXT, and SELECT-BEYOND.

bRINVOQ 15 mg, upadacitinib 30 mg, methotrexate, TNFi, placebo

clong-term data as of 11/14/18

RINVOQ 15 mg is the only approved dose

IR=intolerance or inadequate response; MTX=methotrexate; TNFi=tumor necrosis factor inhibitor

Clinical Trial Overview

SELECT-EARLY (Study RA-I) Study Design Intro:1,4
48-week, double-blind, active comparator-controlled study of 947 adult patients with moderate to severe RA who were MTX-naïve. Patients were randomized to receive RINVOQ 15 mg once daily (n=317) or MTX (n=314). The primary endpoint was ACR50 response at week 12. At week 26, non-responding patients were rescued according to prespecified criteria.

SELECT-MONOTHERAPY (Study RA-II) Study Design Intro:1,5
14-week, double-blind, active comparator-controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX. Patients were randomized to receive RINVOQ 15 mg once daily (n=217) or cMTX weekly (n=216). The primary endpoint was ACR20 response at week 14.

SELECT-NEXT (Study RA-III) Study Design Intro:1,6
12-week, double-blind, placebo-controlled study of 661 adult patients with moderate to severe RA who had an inadequate response to csDMARDs. Patients on background csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=221) or placebo (n=221). The primary endpoint was ACR20 response at week 12.

SELECT-BEYOND (Study RA-V) Study Design Intro:1,8
12-week, double-blind, placebo-controlled study of 499 adult patients with moderate to severe RA who have had an inadequate response or intolerance to bDMARDs. Patients on background csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=164) or placebo (n=169). The primary endpoint was ACR 20 response at week 12.

SELECT-COMPARE (Study RA-IV) Study Design Intro:1,7
48-week, 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. Prespecified blinded rescue protocol occurred at weeks 14, 18, 22, or 26.

Well-studied safety profile Well-studied safety profile Well-studied safety profile

Adverse Events of Special Interest 1,10

Patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as Week 12 depending on the study design.

Vaccination:1 Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines

TEAE=treatment emergent adverse event, defined as an adverse event with an onset date on or after the first dose of oral study drug in controlled short term period and prior to any treatment switching, and no more than 30 days after the last dose of oral study drug1

Long term 1-year analysis cuts at first dose of upadacitinib + 365 days.10

Adverse Events of Special Interest3,9
Long-term safety data as of November 14, 2018 based on >3400 patient-years of exposure from the Phase 3 Program

Long-term safety data Long-term safety data Long-term safety data

Patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as week 12 depending on the study design.

Please see HUMIRA full Prescribing Information.

SELECT-COMPARE was not designed to evaluate safety outcomes between RINVOQ and HUMIRA. Thus, no safety comparison can be made based upon this presentation.

Vaccination:1 Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines

*Included RINVOQ monotherapy and combination therapy with MTX across 5 trials

TEAE=treatment emergent adverse event, defined as an adverse event with an onset date on or after the first dose of oral study drug and up to 30 days after last dose of RINVOQ or 70 days for HUMIRA.9

Most Common Adverse Reactions from SELECT-COMPARE, SELECT-NEXT, and SELECT-BEYOND (12 weeks)1
Adverse reactions reported in ≥1% of moderate to severe rheumatoid arthritis patients treated with RINVOQ 15 mg pooled from the placebo-controlled studies.

Common adverse events Common adverse events Common adverse events


Infections

  • In the placebo‑controlled studies SELECT-COMPARE, SELECT-NEXT, and
    SELECT-BEYOND through 12/14 weeks, infections were reported in 20.9% of patients treated with placebo + csDMARDs and 27.4% in patients treated with RINVOQ 15 mg + csDMARDs
  • In the 12 month pooled safety data,c the incidence rate of infection was 83.8* per 100 patient years for patients treated with RINVOQ 15 mg.

aPatients were on background MTX or csDMARDS.
bURTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection
cSELECT-EARLY, SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-BEYOND
*615/733.6

SELECT-BEYOND:A study of UPADAC in difficult-to-treat patients

 

Dr. Bernard Combe, Rheumatologist, outlines a phase 3 trial in patients with moderately to severely active RA who had failed ≥1 biologic DMARD.

Monitoring and dose interruptions Monitoring and dose interruptions Monitoring and dose interruptions
Lab monitoring Lab monitoring Lab monitoring

Treatment with RINVOQ should not be initiated, or should be interrupted if:

Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection*

*Treatment can be initiated or restarted after levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.

PREGNANCY STATUS:1

  • Verify no pregnancy prior to starting treatment
  • Advise women to use effective contraception during and 4 weeks after treatment

RINVOQ is not recommended for use in patients with severe hepatic impairment.1

Serious Infections:1 Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ.

Tuberculosis:1 Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation:1 Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ.

Embryo-Fetal Toxicity:1 Based on animal studies, RINVOQ may cause fetal harm when administered to pregnant women.

Lab abnormalities from the Controlled Period
of the Phase 3 program (Week 12 or 14)1

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm3) occurred in 1.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lymphopenia: Decreases in lymphocyte counts (<500 cells/mm3) occurred in 0.9% of patients treated with RINVOQ in the first 3 months of exposure.

Anemia: Hemoglobin decreases below 8 g/L in at least one measurement occurred in <0.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lipid Elevations: Increases in lipid parameters including total cholesterol, triglycerides, LDL, and HDL were observed in patients treated with RINVOQ. Elevations in LDL and HDL cholesterol peaked by week 8 and remained stable thereafter.

Liver Enzyme Elevations: Increases in liver enzyme levels >3 times the upper limit of normal were observed in patients treated with RINVOQ.

Creatine Phosphokinase Elevations: Increases in creatine phosphokinase (CPK) levels >5 times the upper limit of normal were observed in patients treated with RINVOQ. Most elevations >5x ULN were transient and did not require treatment discontinuation.

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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