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US-RNQ-230019
RINVOQ showed greater inhibitory potency for JAK1 and JAK2 relative to JAK3 and TYK2
Via cell-free isolated enzyme essays1,2


Inhibition of STAT Phosphorylation
In human leukocyte cellular assays, upadacitinib inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation.
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1
IC50 (half-maximal inhibitory concentration) indicates how much drug is needed to inhibit a biological process by half. For this graphic, IC50 is the concentration of upadacitinib whereby 50% of the activity of the respective JAK isoform is inhibited.
*A low IC50 implies a higher potency.
INDICATION & LIMITATIONS OF USE1
INDICATION1
RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for
IMPORTANT SAFETY INFORMATION1
WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, 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, such as azathioprine and cyclosporine. If a
IMPORTANT SAFETY INFORMATION1
WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, 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, such as
INDICATION & LIMITATIONS OF USE1
INDICATION1
RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for
IMPORTANT SAFETY INFORMATION1
WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, 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, such as azathioprine and cyclosporine. If a
IMPORTANT SAFETY INFORMATION1
WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, 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, such as
IMPORTANT SAFETY
INFORMATION & INDICATION1
INDICATION1
RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with other potent immunosuppressants such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION
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 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.
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.
MORTALITY
In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor with 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 CV death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ.
MALIGNANCIES
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.
With RINVOQ, 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. NMSCs 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 EVENTS
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, myocardial infarction, and 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 CV risk factors. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
THROMBOSIS
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.
HYPERSENSITIVITY
RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis and patients taking NSAIDs or corticosteroids). Promptly evaluate patients presenting with new onset abdominal pain for early identification of GI 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-treated patients. 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-treated patients. 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 patients 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 findings in 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
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 varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
MEDICATION RESIDUE IN STOOL
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic or functional GI conditions with shortened GI transit times. Instruct patients to contact their healthcare provider if medication residue is observed repeatedly. Monitor patients clinically and consider alternative treatment if there is an inadequate therapeutic response.
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 for use in patients with severe hepatic impairment.
ADVERSE REACTIONS
The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, rash, and anemia.
Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.
Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.
US-RNQ-230034
Please see full Prescribing Information.
For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1
RINVOQ IS A

RINVOQ is an oral small molecule that inhibits the JAK-STAT signaling pathway, utilized by pro-inflammatory cytokines.1,2
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
IR=intolerance or inadequate response;
TNFi=tumor necrosis factor inhibitor


Ulcerative Colitis:
Mechanism
of Disease (MOD)
Ulcerative Colitis:
Mechanism of
Disease (MOD)

Ulcerative Colitis (UC):
A chronic
& complex
disease
of the colon
UC is an immune-mediated, inflammatory condition of the large intestine and is characterized by bleeding, urgency and tenesmus.3
UC is an immune-mediated, inflammatory condition of the large intestine and is characterized by bleeding, urgency and tenesmus.3
Ulcerative Colitis (UC):
Several key cytokines are thought to use signaling networks such as the JAK-STAT Pathway.
Overexpression of these key cytokines can lead to excess inflammation and may contribute to the signs and symptoms of UC.4,5
CYTOKINES
Pro-inflammatory Cytokines
Involved in UC Pathogenesis1,5
Inside the cell
The cytokines that activate JAK-STAT pathways contribute to the pathogenesis of UC through their role in inflammation. However, these same cytokines are also important for general cellular functions such as immune system modulation, cell growth, and hematopoiesis.1,5
The cytokines that activate JAK-STAT pathways contribute to the pathogenesis of UC through their role in inflammation. However, these same cytokines are also important for general cellular functions such as immune system modulation, cell growth, and hematopoiesis.1,5

Mechanism
of Action

Cytokine
Jak
Rinvoq
How Rinvoq Works
RINVOQ targets JAK, affecting the JAK-STAT pathway inside the cell, which is linked to the signalling of pro-inflammatory cytokines.1,2
Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK1 and JAK2 relative to JAK3 and TYK2.1,2
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not known.
inhibitory Potency
Across Cytokines


Cytokine
Jak
Rinvoq
STAT
How Rinvoq Works
By binding JAK, RINVOQ prevents the phosphorylation and activation of STATs, disrupting the pro-inflammatory signaling cascade.1,2
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not known.
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not known.

ONE PILL,


In clinical trials, RINVOQ has been shown to provide significant clinical remission at Week 8 and Week 52 and powerful histo-endoscopic mucosal improvement* for moderate to severe UC in adult TNFi-IR patients.1
to disease progression and long-term outcomes
was not evaluated.
and long-term outcomes was not evaluated.

Mechanism
of Disease
The Role of the
JAK-STAT PATHWAY4,5
Pro-inflammatory cytokines utilize signaling pathways — such as the JAK-STAT pathway — to communicate with the cell nucleus.
The cytokine binds to a specific receptor on the cell surface that modulates JAK-mediated signaling.

Inside the cell
Jak
Jak
The Role of the
JAK-STAT PATHWAY4,5
The receptor spans the cell's membrane and cytokine binding triggers JAK activation inside the cell.


STAT

STAT
The Role of the
JAK-STAT PATHWAY4,5
The activated JAK then mobilizes STATs,
which transmit the signal into the cell nucleus.

STAT
STAT
Inside the cell
The Role of the
JAK-STAT PATHWAY4,5
This signaling contributes to the inflammatory response in UC.
RINVOQ IS A

By targeting JAK, RINVOQ is thought to block the
recruitment, phosphorylation, and activation of
STATs and inhibit the pro-inflammatory processes
associated with the JAK-STAT pathway.1,4,5
By targeting JAK, RINVOQ is
thought to block the recruitment,
phosphorylation, and activation
of STATs and inhibit the
pro-inflammatory processes
associated with the JAK-STAT
pathway.1,5
The relevance of inhibition of specific JAK enzymes
to therapeutic effectiveness is not currently known.
The relevance of inhibition
of specific JAK enzymes to therapeutic effectiveness is not currently known.
IMPORTANT SAFETY
INFORMATION & INDICATION1
INDICATION1
RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with other potent immunosuppressants such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION
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 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.
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.
MORTALITY
In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor with 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 CV death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ.
MALIGNANCIES
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.
With RINVOQ, 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. NMSCs 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 EVENTS
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, myocardial infarction, and 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 CV risk factors. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
THROMBOSIS
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.
HYPERSENSITIVITY
RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs). Promptly evaluate patients presenting with new onset abdominal pain for early identification of GI 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-treated patients. 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-treated patients. 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 patients 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 findings in 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
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 varicella zoster or prophylactic herpes 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 for use in patients with severe hepatic impairment.
ADVERSE REACTIONS
The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash.
Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.
Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.
US-RNQR-220143
Please see full Prescribing Information.
REFERENCES
- RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
- Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol. 2018;2:23.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.
- Neurath M. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014;14:329–342.
- Salas A, Hernandez-Rocha C, Duijvestein M, et al. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020;17(6):323-337.