CONTACT
A REP
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
US-MULT-240253
For moderate to severe Crohn's disease (CD) in adult TNFi-IR patients.1
For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1
IMPORTANT SAFETY INFORMATION & INDICATION1
INDICATION1
RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biological therapies for Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)
SERIOUS INFECTIONS
- 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.
MORTALITY
MALIGNANCIES
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
THROMBOSIS
HYPERSENSITIVITY
GASTROINTESTINAL PERFORATIONS
LABORATORY ABNORMALITIES
EMBRYO-FETAL TOXICITY
VACCINATION
MEDICATION RESIDUE IN STOOL
LACTATION
HEPATIC IMPAIRMENT
ADVERSE REACTIONS
STUDY DESIGN AND BASELINE CHARACTERISTICS
For adult patients with moderately to severely active Crohn's disease (CD).1
1st clinical trials for an approved moderate-to-severe Crohn's treatment to require steroid taper during induction period
12-WEEK INDUCTION
TRIALS
Randomized double-blind, placebo-controlled trials
(N=857)
52-WEEK MAINTENANCE
TRIAL
Randomized double-blind, placebo-controlled trial, that evaluated patients who achieved clinical response* after 12 weeks of treatment with RINVOQ 45 mg once-daily in induction trials (N = 343)
*Clinical response was defined as a reduction of Crohn's disease activity index (CDAI) ≥100 points from baseline
†The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
‡Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
§Induction responders achieved clinical response, defined as a reduction of CDAI score ≥100 points from baseline.
||Bio-naïve patients included some patients who were exposed to but did not have inadequate response, loss of response, or intolerance to one or more biologic treatments for Crohn's disease.
U-EXCEL Induction & U-EXCEED Induction
CO-PRIMARY ENDPOINTS1
- Clinical remission at Week 12*
- Endoscopic response at Week 12†
SELECT SECONDARY ENDPOINTS1
- Clinical response at Week 2‡
- Endoscopic remission at Week 12§
- Steroid-free clinical remission at Week 12||
*Clinical remission was defined as CDAI >150 points.
†Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
‡Clinical response was defined as a reduction of Crohn's disease activity index (CDAI) ≥100 points from baseline.
§Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
||Steroid-free clinical remission at Week 12 was defined as discontinuation of corticosteroid use for CD and achievement of CDAI clinical remission among patients on steroid at baseline.
<<Swipe table to see more
RINVOQ is indicated for TNFi-IR patients.
aThe mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
bPrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
cStratification factors for randomization.
dBio-naïve patients included some patients who were exposed to but did not have inadequate response, loss of response, or intolerance to one or more biologic treatments for Crohn's disease.
AP=abdominal pain; CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn's disease; hs-CRP=high-sensitivity C-reactive protein
REFERENCES: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on File. ABVRRTI75381.
U-ENDURE Maintenance
CO-PRIMARY ENDPOINTS1
- Clinical remission at Week 52*
- Endoscopic response at Week 52†
SELECT SECONDARY ENDPOINTS1
- Endoscopic remission at Week 52‡
- Steroid-free clinical remission at Week 12§
*Clinical remission was defined as CDAI >150 points.
†Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES-CD assessment).
‡Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
§Steroid-free clinical remission at Week 52 was defined as no corticosteroid use for CD ≥90 days prior to Week 52 and achievement of CDAI clinical remission
(among the subset of patients who were on steroids at induction baseline).
<<Swipe table to see more
RINVOQ is indicated for TNFi-IR patients.
aThe mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well as some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
bBio-naïve patients included some patients who were exposed to but did not have inadequate response, loss of response, or intolerance to one or more biologic treatments for Crohn's disease.
cPrior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
AP=abdominal pain; CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn's disease; hs-CRP=high-sensitivity C-reactive protein
REFERENCES: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on File. ABVRRTI75382.
US-MULT-231358