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The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.1
US-MULT-240253
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI® (risankizumab-rzaa)1 Indications Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults. |
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Inflammatory Bowel Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn's disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn's disease.
Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Please see Full Prescribing Information.
US-SKZG-240258
UC STUDY DESIGN AND BASELINE CHARACTERISTICS
Primary endpoint1:
- Clinical remission at Week 12||
Select secondary endpoints1:
- Clinical response at Week 4¶
- Clinical response at Week 12§
- Endoscopic improvement at Week 12#
- No bowel urgency at Week 12**
aAdvanced therapy-naïve patients include some patients who were exposed to an advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) but did not experience treatment failure.
bAdvanced therapy-failure patients include patients who had an inadequate response or intolerance with one or more advanced therapies (biologics, JAK inhibitors, and/or S1P receptor modulators).
§Clinical response at Week 12 in UC per modified Mayo Score is a composite of Mayo stool frequency, rectal bleeding subscores, and endoscopy subscores, and was defined as a decrease in total score ≥30% and ≥2 points from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.1
||Clinical remission in UC is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.1
¶Clinical response at Week 4 in UC per partial modified Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and was defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.1
#Endoscopic improvement in UC is defined as Mayo endoscopic subscore of 0 or 1 without friability.1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator.
**No bowel urgency in UC is defined as if subject reported no bowel urgency on the most recent 3 days up to 10 days prior to each study visit.3
hs-CRP=high-sensitivity C-reactive protein; IV=intravenous; JAK=Janus kinase; kg=kilogram; mg/L=milligrams per liter; S1P=Sphingosine-1-phosphate; SC=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Data on File, AbbVie Inc. ABVRRTI78805.
- Louis E, Panaccione R, Parkes G, et al. Risankizumab induction therapy in patients with moderately to severely active ulcerative colitis. Presented at: United European Gastroenterology Week; October 14-17, 2023; Copenhagen, Denmark.
Primary endpoint (All Subjects Maintenance Population)1:
- Clinical remission at Week 52||
Select secondary endpoints (All Subjects Maintenance Population)1:
- Corticosteroid-free remission at Week 52¶
- Endoscopic improvement at Week 52#
- Endoscopic remission at Week 52**
- Histo-endoscopic mucosal improvement at Week 52††
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aAdvanced therapy-naïve patients include some patients who were exposed to an advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) but did not experience treatment failure.
bAdvanced therapy-failure patients include patients who had an inadequate response or intolerance with one or more advanced therapies (biologics, JAK inhibitors and/or S1P receptor modulators).
†Patients who achieved clinical response with SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.
§Clinical response at Week 12 in UC per modified Mayo Score is a composite of Mayo stool frequency, rectal bleeding subscores, and endoscopy subscores, and was defined as a decrease in total score ≥30% and ≥2 points from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.1
IIClinical remission in UC is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.1
¶Steroid-free clinical remission in UC is defined as clinical remission per modified Mayo Score (rectal bleeding, stool frequency, endoscopic subscore) at Week 52 and corticosteroid-free for ≥90 days immediately preceding Week 52.1
#Endoscopic improvement in UC is defined as Mayo endoscopic subscore of 0 or 1 without friability.1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator.
**Endoscopic remission in UC is defined as Mayo endoscopic subscore of 0.1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator.
††Histo-endoscopic mucosal improvement in UC is defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
hs-CRP=high-sensitivity C-reactive protein; IV=intravenous; JAK=Janus kinase; kg=kilogram; mg/L=milligrams per liter; S1P=Sphingosine-1-phosphate; SC=subcutaneous; TNF=tumor necrosis factor; UC=ulcerative colitis.
REFERENCES
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Data on File, AbbVie Inc. ABVRRTI78805.
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