For moderate to severe patients 12+ years not adequately controlled with other systemic drugs, including biologics.1
FAVORABLE
BENEFIT-
RISK PROFILE
ESTABLISHED IN ALL 7 FDA-APPROVED INDICATIONS1-3
11 years
of clinical trial experience2†
EVALUATED ACROSS 25
CLINICAL TRIALS‡ IN RA, PsA,
AD,† UC, AS, nr-axSpA, and CD1,2
>13,000
PATIENTS IN GLOBAL CLINICAL TRIALS ACROSS US-APPROVED INDICATIONS, INCLUDING PEDIATRICS 12+ YEARS IN AD1,2‡
~ 5 years
of real world experience1
APPROVED IN
RA, PsA, AD,
UC, AS,
nr-axSpA, AND CD
AND 3 DIFFERENT DOSING STRENGTHS (15 mg, 30 mg, and 45 mg)1
OVER 267,000
PATIENTS PRESCRIBED GLOBALLY ACROSS INDICATIONS SINCE 20191,3§
AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; JAK=Janus kinase; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; UC=ulcerative colitis.
*As of 9/2023. Source: Integrated Symphony Health (PatientSource) and IQVIA (NSP).
†Clinical experience encompasses the time from the first RINVOQ clinical trial to present.
‡Includes 3 Phase 2 trials and 6 Phase 3 RA trials, 2 Phase 3 PsA trials, 1 Phase 2/3 and 1 Phase 3 AS trial, 1 Phase 3 nr-axSpA trial, 1 Phase 2 and 3 Phase 3 AD trials, 3 Phase 3 UC trials, and 1 Phase 2 and 3 Phase 3 CD trials. RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; nr-axSpA: RINVOQ 15 mg; AD: RINVOQ 15 mg and 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg; CD: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in RA, PsA, AS, and nr-axSpA; RINVOQ 15 mg and 30 mg are the approved doses in AD; RINVOQ 15 mg, 30 mg, and 45 mg are the approved doses in UC and CD.1,2
§Based on prescription data with RINVOQ in patients with RA, PsA, nr-axSpA, AS, AD, UC, or CD as of September 2023.3
Well-studied safety profile at 16 weeks5
Adverse events (AEs) of special interest in all subjects through Week 16: integrated safety5
aAll events were eczema herpeticum.
bPer protocol, patients experiencing AEs of malignancy (except for localized NMSC or cancer of the cervix in situ), adjudicated GI perforations, and adjudicated VTE were required to discontinue therapy.
MACE=major adverse cardiac event; n/100 PY=number of subjects with at least 1 event per 100 PY; NMSC=non-melanoma skin cancer; PYs=patient years; TB=tuberculosis; VTE=venous thromboembolism.
AEs of Special Interest: AEs with an onset date that is on or after the first dose of study drug and no more than 30 days after the last dose of upadacitinib and placebo.
MACE defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
Safety rates up to 5 years6
Adverse events of special interest in all subjects: long-term integrated safety6
aRates shown are n/100 PY=number of subjects with at least 1 event per 100 PY. Per protocol, patients experiencing AEs of malignancy (except for localized NMSC or cancer of the cervix in situ), adjudicated GI perforations, and adjudicated VTE were required to discontinue therapy.
Adverse reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.
The adverse reaction profile in the pediatric patients was similar to the adults.1
Safety rates in pediatric patients up to 5 years5-7
Adverse events of special interest in pediatric patients 12+ years: integrated safety5-7
(MEASURE UP 1, 2, and AD UP)
aRates shown are n/100 PY=number of subjects with at least 1 event per 100 PY. Per protocol, patients experiencing AEs of malignancy (except for localized NMSC or cancer of the cervix in situ), adjudicated GI perforations, and adjudicated VTE were required to discontinue therapy.
bLong-term: safety data through November 24, 2020 (64%-66% of patients had >1 year of exposure to RINVOQ; total exposure=2,788 PYs).7
Adverse reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.
The adverse reaction profile in the pediatric patients was similar to the adults.1
SAFETY CONSIDERATIONS1
Serious Infections1: Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death. These infections include tuberculosis (TB) and invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens. 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.
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.
Mortality1: In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ.
Malignancies1: Lymphoma and other malignancies have been observed in patients treated with RINVOQ. In a large, randomized, postmarketing safety study comparing another JAK inhibitor with TNF blockers in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in current or past smokers) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.
Non-melanoma skin cancers have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Advise patients to limit sunlight exposure by wearing protective clothing and using sunscreen.
Major Adverse Cardiovascular Events1: In a large, randomized, postmarketing study comparing another JAK inhibitor with TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.
Thrombosis1: Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death.
In a large, randomized, postmarketing study comparing another JAK inhibitor to TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ and be promptly evaluated.
Gastrointestinal Perforations1: Gastrointestinal perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (eg, patients with a history of diverticulitis or taking NSAIDs or corticosteroids). Promptly evaluate patients presenting with new onset abdominal pain for early identification of gastrointestinal perforation.
Vaccination1: Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, in agreement with current immunization guidelines.
STUDY DESIGNS
Measure Up
MEASURE UP 1 (N=847) and MEASURE UP 2 (N=836) were phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ (15 mg or 30 mg) vs placebo over 16 weeks in adult and pediatric (≥12 years) patients with moderate to severe atopic dermatitis. Patients were randomized 1:1:1 to receive RINVOQ 15 mg, RINVOQ 30 mg, or placebo. Patients who completed the original 16-week double-blind MEASURE UP studies entered the blinded extension treatment period. Following the completion of enrollment of MEASURE UP 1 and MEASURE UP 2, a supplemental study continued to enroll adolescent subjects until 180 adolescents were enrolled in MEASURE UP 1 and 180 adolescents were enrolled in MEASURE UP 2.1,8,9
AD Up
AD UP (N=901) was a phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RINVOQ (15 mg or 30 mg) + TCS vs placebo + TCS in adult and pediatric (≥12 years of age) patients with moderate to severe atopic dermatitis. Co-primary endpoints were EASI 75 and vIGA 0/1 response vs placebo at Week 16. Patients were randomized 1:1:1 to receive RINVOQ 15 mg, RINVOQ 30 mg, or placebo—all in combination with TCS. Patients who completed the original 16-week double-blind AD UP study entered the blinded extension treatment period. Following the completion of enrollment of AD UP, a supplemental study continued to enroll adolescent subjects until 180 adolescents were enrolled in AD UP.9-11
Common adverse events
Most common adverse events ≥1% in all subjects through Week 16: integrated safety1
Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in a broader patient population in clinical practice.
aIncludes: laryngitis, laryngitis viral, nasopharyngitis, oropharyngeal pain, pharyngeal abscess, pharyngitis, pharyngitis streptococcal, pharyngotonsillitis, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinolaryngitis, sinusitis, tonsillitis, tonsillitis bacterial, upper respiratory tract infection, viral pharyngitis, viral upper respiratory tract infection.
bIncludes: acne and dermatitis acneiform.
cIncludes: genital herpes, genital herpes simplex, herpes dermatitis, herpes ophthalmic, herpes simplex, nasal herpes, ophthalmic herpes simplex, herpes virus infection, oral herpes.
dIncludes anaphylactic reaction, anaphylactic shock, angioedema, dermatitis exfoliative generalized, drug hypersensitivity, eyelid oedema, face oedema, hypersensitivity, periorbital swelling, pharyngeal swelling, swelling face, toxic skin eruption, type I hypersensitivity, urticaria.
eIncludes abdominal pain and abdominal pain upper.
fIncludes herpes zoster and varicella.
Most common adverse events in ≥5% in pediatrics 12+ years through Week 16: integrated safety5
Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in a broader patient population in clinical practice.
The adverse reaction profile in the pediatric patients was similar to the adults.1
SAFETY ACROSS INDICATIONS
Long-term safety data across 7 indications1,2
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| RHEUMATOLOGY | DERMATOLOGY | GASTROENTEROLOGY | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| RA | PsA | AS | nr-axSpA | AD | UC | CD | ||||
| TEAE OF SPECIAL INTERESTa (E/100 PY unless otherwise noted) | RINVOQ 15 mg | RINVOQ 15 mg | RINVOQ 30 mg | RINVOQ 15 mg | RINVOQ 30 mg | RINVOQ 15 mg | RINVOQ 30 mg | |||
| (N=3209, PY=11,661.5) | (N=907, PY=2,823.7) | (N=596, PY=1,022.2) | (N=286, PY=388.4) | (N=1,337 PY=3,823.0) | (N=1,346 PY=4,076.9) | (N=285, PY=622.7) | (N=291, PY=721.9) | (N=221, PY=329.5) | (N=760, PY=1371.2) | |
| INFECTIONS | ||||||||||
| Serious infection | 3.6 | 3.3 | 2.4 | 1.3 | 2.2 | 2.6 | 2.9 | 4.4 | 3.6 | 6.7 |
| Opportunistic infection (excluding TB and herpes zoster) |
0.3 | 0.4 | 0.2 | 0.3 | 1.7 | 2.2 | 0.3 | 0.6 | 0.6 | 0.4 |
| Active TB | <0.1 | 0 | 0 | 0 | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 |
| Herpes zoster | 3.2 | 3.1 | 3.1 | 2.6 | 3.1 | 5.5 | 4.3 | 6.6 | 2.7 | 5.0 |
| MALIGNANCYb | ||||||||||
| Malignancy (excluding NMSC) | 0.7 | 0.7 | 0.2 | 0.3 | 0.3 | 0.4 | 0.6 | 0.6 | 0.6 | 0.9 |
| Lymphoma | <0.1 | 0.1c | <0.1c | 0.3 | <0.1 | <0.1 | 0 | 0 | 0 | 0.1 |
| NMSC | 0.4 | 0.7 | 0.3 | 0.3 | 0.4 | 0.3 | 0 | 1.0 | 0 | 0.6 |
| CARDIOVASCULAR EVENTSb | ||||||||||
| Adjudicated MACEd | 0.3 | 0.4 | 0.2 | 0.5 | 0.2 | <0.1 | 0 | 0.4 | 0 | 0.1 |
| Adjudicated VTEe | 0.4 | 0.2 | 0.3 | 0.8 | 0.1 | 0.1 | 0.5 | 0.6 | 0 | 0.3 |
| GASTROENTEROLOGICAL EVENTSb | ||||||||||
| Adjudicated gastrointestinal perforations | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 | 0 | 0 | 0.9 | 0.5 |
In CD studies: Includes 3 phase 3 trials as of 8/2023. Includes those who responded to 45 mg indication dose to RINVOQ at Week 12. In UC studies: Includes 3 phase 3 studies as of 8/2023. Includes those who responded to 45 mg induction dose to RINVOQ at week 8 or 6. In RA studies: Includes 6 phase 3 trials as of 8/2023. In AS studies: Includes 1 phase 2/3 and 1 phase 3 trial as of 8/2023. In AD studies: Includes 3 phase 3 trials including adults and adolescents as of 8/2023. In PsA studies: Includes 2 phase 3 trials as of 8/2023. In nr-axSpA studies: Includes 1 phase 3 trial as of 8/2023.
Adverse reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.
RINVOQ is taken once daily.
Select baseline medical history in
RINVOQ AD phase 3 clinical trials6
Select baseline characteristics in clinical trials6
Select baseline
characteristics in clinical
trials6
aCV risk factors included CV event, hypertension, diabetes mellitus, tobacco/nicotine use, elevated LDL-C, and lowered HDL-C.
CV=cardiovascular; VTE=venous thromboembolic events.
RINVOQ WAS STUDIED IN PATIENTS 12-75 YEARS OLD WITH VARIOUS COMORBIDITIES
>50% had at least 1 CV risk factora
>30% were current or former smokers
~20% of females were using OCP
~15% were ≥50 years of age with ≥1 CV risk factora
Consider benefits and risks for individual patients prior to initiating or continuing therapy with RINVOQ, particularly in those who are current or past smokers and patients with other CV risk factors. Discontinue RINVOQ in patients that have experienced myocardial infarction or stroke. Avoid RINVOQ in patients that may be at increased risk for thrombosis. Patients with symptoms of thrombosis should discontinue RINVOQ and be promptly evaluated.
ADDITIONAL ACNE CONSIDERATIONS1,5
Through Week 16 in all subjects, acne events occurred in 10% and 16% of patients in the RINVOQ 15 mg group (n=899) and RINVOQ 30 mg group (n=906), respectively, compared with 2% in the placebo group (n=902).
(2/1,805) patients discontinued treatment due to acne (15 mg and 30 mg)
>99% of the cases were considered mild or moderate in severity
Among patients who experienced acne, >95% had facial involvement
Monitoring
Lab monitoring1,12
Perform lab tests at baseline,§ at 12 weeks,|| and periodically thereafter
§USPI recommendation for CBC and liver enzymes: at baseline and periodically thereafter
||USPI recommendation for lipids: at 12 weeks and thereafter according to hyperlipidemia guidelines
Treatment may be restarted when blood levels return to acceptable values seen in chart above, drug-induced liver diagnosis is excluded or infection is controlled.1
RINVOQ is not recommended for use in patients with severe hepatic impairment or end-stage renal disease.1
Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.1
Avoid RINVOQ in patients that may be at increased risk of thrombosis.1
Baseline screening1
At baseline and periodically, screen for:
- SERIOUS INFECTIONS1
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ. Interrupt RINVOQ if a patient develops a serious or opportunistic infection.
- TUBERCULOSIS1
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 REACTIVATION1
Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ.
- PREGNANCY1
Based on animal studies, RINVOQ may cause embryo-fetal toxicity when administered to pregnant women. Verify pregnancy status prior to starting treatment. Advise women to use effective contraception during and for 4 weeks after completion of treatment.
- VACCINATIONS1
Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
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For adults <65 years and pediatric patients 12+ years weighing at least 40 kg (88 lb), initiate treatment with RINVOQ 15 mg once daily in pediatric patients (≥12 years, ≥40 kg) and adults <65 years of age. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response. For patients ≥65 years, patients receiving strong CYP3A4 inhibitors, and patients with severe renal impairment, the recommended dose of RINVOQ is 15 mg once daily. Coadministration of RINVOQ with strong CYP3A4 inducers is not recommended.1
