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
INDICATIONS1-4
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 7/2022. Source: Integrated Symphony Health (PatientSource) and IQVIA (NSP).
†Adults and pediatrics 12+.
‡Based on prescription data with RINVOQ in patients with RA, PsA, AS, AD, or UC as of December 2022.
Well-studied safety profile at 16 weeks6
Adverse events (AEs) of special interest in all subjects through Week 16: integrated safety6
aAll events were eczema herpeticum.
bPer protocol, patients experiencing AEs of malignancy (except for localized NMSC or cancer of the cervix in situ) 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 4 years4
Adverse events of special interest in all subjects: long-term integrated safety4
cRates 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) 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 4 years4
Adverse events of special interest in pediatric patients 12+ years: integrated safety4
(MEASURE UP 1, 2, and AD UP)
dRates 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) 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 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). 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 with all immunizations, including prophylactic 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 of age) patients with moderate to severe atopic dermatitis. Adult patients who completed the original 16-week double-blind MEASURE UP studies were eligible for blinded, extended treatment for at least 52 weeks.1,7
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 over 16 weeks in adult and pediatric (≥12 years of age) patients with moderate to severe atopic dermatitis. Patients who completed the original 16-week double-blind AD UP study were eligible for blinded, extended treatment for at least 52 weeks.8,9
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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.
eIncludes: 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.
fIncludes: acne and dermatitis acneiform.
gIncludes: genital herpes, genital herpes simplex, herpes dermatitis, herpes ophthalmic, herpes simplex, nasal herpes, ophthalmic herpes simplex, herpes virus infection, oral herpes.
hIncludes 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.
iIncludes abdominal pain and abdominal pain upper.
jIncludes herpes zoster and varicella.
Most common adverse events in ≥5% in pediatrics 12+ years through Week 16: integrated safety6
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
Select baseline medical history in
RINVOQ AD phase 3 clinical trials10
Select baseline characteristics in clinical trials10
kCV 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 COMORBIDITIES10
>50% had at least 1 CV risk factork
>30% were current or former smokers
~20% of females were using OCP
~15% were ≥50 years of age with ≥1 CV risk factor
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.
Monitoring
§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
- 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.
Lab abnormalities: placebo-controlled period through 16 weeks1,8,13
>99% of patients did not experience a treatment interruption due to lab changes8
kIncludes subjects from M16-048, MEASURE UP 1, MEASURE UP 2, and AD UP.
AD=atopic dermatitis; ALT=alanine aminotransferase; AST=aspartate transaminase; CPK=creatine phosphokinase; HDL=high-density lipoprotein; LDL=low-density lipoprotein; ULN=upper limit of normal.
Lab changes (ANC, ALC, Hgb, LFT) occurred within the first 4-8 weeks, were transient, and generally returned to baseline levels within the normal range without study drug discontinuation8,9,13
For adults <65 years and pediatric patients 12+ years weighing at least 40 kg (88 lb), initiate treatment with RINVOQ 15 mg once-daily. 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
