SAFETY PROFILE FOR SKYRIZI
Consistent Safety Profile Observed up to ~10 Years in Crohn’s and UC2-7
SKYRIZI SAFETY PROFILE
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| Pooled Induction Trial Data from Phase 2 and ADVANCE & MOTIVATE Crohn’s at Week 12 |
INSPIRE UC at Week 12 |
||||
|---|---|---|---|---|---|
| Adverse Events (AEs) | SKYRIZI 600 mg IV* N=620 |
Placebo N=432 |
SKYRIZI 1200 mg IV† N=712 |
Placebo N=383 |
|
| Treatment-emergent AEs | % | % | % | % | |
| Any AE | 54.7 | 63.4 | 42.3 | 51.7 | |
| Serious AE | 6.6 | 15.5 | 2.7 | 10.2 | |
| AE Leading to Discontinuation of Study Drug |
2.1 | 8.6 | 0.8 | 4.4 | |
| Death | 0 | 0.5 | 0.1 | 0 | |
| AEs of Special Interest | % | % | % | % | |
| Infections | |||||
| Infections | 19.7 | 24.8 | 14.9 | 16.7 | |
| Serious Infection | 1.0 | 3.7 | 0.7 | 1.0 | |
| Opportunistic Infection (Excluding TB/Herpes Zoster) | 0 | 0.7 | 0 | 0 | |
| Active Tuberculosis (TB) | 0.2 | 0.2 | 0 | 0 | |
| Herpes Zoster | 0.3 | 0.2 | 0.3 | 0.3 | |
| Malignancy | |||||
| NMSC | 0 | 0 | 0 | 0 | |
| Malignancy (Excluding NMSC) | 0 | 0 | 0 | 0.8 | |
| Cardiovascular Events | |||||
| Adjudicated MACE‡ | 0 | 0 | 0 | 0 | |
| Other | |||||
| Hypersensitivity (Serious Events Only) | 0.2 | 0.2 | 0 | 0.3 | |
| Adjudicated Anaphylactic Reaction | 0 | 0 | 0 | 0 | |
| Hepatic Events | 1.6 | 1.6 | 1.5 | 4.2 | |
| Injection Site Reactions | 0.8 | 1.2 | 0.7 | 1.6 | |
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.1
In the treatment of Crohn’s, drug-induced liver injury during induction has been reported. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin levels at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management.1
In the Crohn’s 12-week induction studies, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include upper respiratory infections, headache, and arthralgia.1
In the UC 12-week induction study, the most common adverse reactions (≥3% of patients and at a higher rate than placebo) include arthralgia.1
*Data pooled from 12-week SKYRIZI induction treatment in patients with moderately to severely active Crohn's disease in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2) and a randomized, double-blind, placebo-controlled, dose-finding study (CD-4; NCT02031276).2
†Data are integrated from a Phase 2b and a Phase 3 clinical trial in UC.
‡Defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.3
AEs=adverse events; IV=intravenous; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; TB=tuberculosis.
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| FORTIFY Crohn’s at Week 52 |
COMMAND UC at Week 52* |
|||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Events (AEs) | SKYRIZI 180 mg SC N=155, PYs=149.4 |
SKYRIZI 360 mg SC N=142, PYs=134.8 |
Continuous Placebo N=81, PYs=60.5 |
Placebo (Induction Responders) N=143, PYs=124.4 |
SKYRIZI 180 mg SC N=170, PYs=163.4 |
SKYRIZI 360 mg SC N=177, PYs=159.0 |
Continuous Placebo N=68, PYs=52.3 |
Placebo (Induction Responders) N=173, PYs=155.7 |
| Treatment-emergent AEs | % | % | % | % | % | % | % | % |
| Any AE | 69 | 70 | 75 | 71 | 70 | 70 | 68 | 75 |
| Serious AE | 11 | 13 | 16 | 10 | 4 | 5 | 12 | 8 |
| AE Leading to Discontinuation of Study Drug | 2 | 3 | 6 | 2 | 2 | 2 | 6 | 1 |
| Death | 0 | 0 | 0 | 0 | 0 | 0.6 | 0 | 0 |
| AEs of Special Interest | % (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
% (E/100 PYs) |
| Infections | ||||||||
| Infections | 32 (50.2) | 37 (60.8) | 33 (66.1) | 36 (60.3) | 32 (69.1) | 36 (59.1) | 27 (49.7) | 36 (60.4) |
| Serious Infection | 3 (2.7) | 6 (7.4) | 4 (8.3) | 2 (2.4) | 1.2 (1.2) | 0.6 (0.6) | 1.5 (3.8) | 1.7 (1.9) |
| Opportunistic Infection (Excluding TB/Herpes Zoster)† | 0 | 1 (0.7) | 0 | 0 | 0 | 0.6 (0.6) | 0 | 0 |
| Active Tuberculosis (TB) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Herpes Zoster | 1 (1.3) | 0 | 0 | 1 (0.8) | 0.6 (0.6) | 0.6 (0.6) | 0 | 1.7 (1.9) |
| Malignancy | ||||||||
| NMSC | 0 | 0 | 0 | 1 (0.8) | 0 | 0 | 0 | 0.6 (0.6) |
| Malignancy (Excluding NMSC)‡ | 0 | 0 | 0 | 0 | 0 | 1 (1.3) | 0 | 0 |
| Cardiovascular Events | ||||||||
| Adjudicated MACE§ | 0 | 1 (0.7) | 0 | 1 (0.8) | 0 | 0 | 0 | 0 |
| Other | ||||||||
| Hypersensitivity (Serious Events Only) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adjudicated Anaphylactic Reaction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hepatic Events|| | 3 (4.7) | 5 (6.7) | 1 (1.7) | 2 (2.4) | 2 (1.8) | 7 (11.3) | 3 (3.8) | 0.6 (1.9) |
| Injection Site Reactions | 5 (10.0) | 6 (13.4) | 0 | 3 (4.8) | 3 (7.3) | 3 (6.3) | 1.5 (7.6) | 1 (1.9) |
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.1
In the treatment of Crohn’s, drug-induced liver injury during induction has been reported. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin levels at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management.1
In the Crohn's 52-week maintenance study, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.1
In the UC 52-week maintenance study, the most common adverse reactions (≥3% of patients and at a higher rate than placebo) include arthralgia, pyrexia, injection site reactions, and rash.1
Continuous Placebo: Patients who responded to placebo in induction (CR-100)¶ were not randomized and continued on placebo in maintenance. These patients were not included in the primary efficacy analysis.9
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)¶ to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.3
*Includes patients who received 1200 mg or 1800 mg IV in the Phase 2b/3 INSPIRE induction study. The 1800 mg is not an FDA-approved induction dose.6
†In the Crohn’s long-term safety study, there was one non-serious event of opportunistic infection (Aeromonas infection); one serious event of disseminated histoplasmosis occurred.3
‡In the Crohn’s long-term safety study, there were two serious events of malignancies excluding NMSCs that occurred in the long-term extension (intestinal carcinoma and thyroid papillary carcinoma).3
§In the Crohn’s long-term safety study, defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.3
||In the Crohn’s long-term safety study, most hepatic events were liver enzyme elevations; none of the events were serious.3,8
¶Clinical response was defined as a reduction of CDAI score ≥100 points from baseline.1
AEs=adverse events; CDAI=Crohn’s disease activity index; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PYs=patient-years; SC=subcutaneous; TB=tuberculosis.
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~3 Years of Safety Data in Crohn’s3-5
| Maintenance FORTIFY Crohn’s at Week 52 |
Long-Term Safety in Crohn’s Max Exposure: 10.16 yrs Median Exposure: 3.60 yrs Mean Exposure: 3.24 yrs |
|||
|---|---|---|---|---|
| Adverse Events (AEs) | SKYRIZI 180 mg SC N=155, PYs=149.4 |
SKYRIZI 360 mg SC N=142, PYs=134.8 |
Placebo (Induction Responders) N=143, PYs=124.4 |
SKYRIZI 180/360 mg SC N=1926, PYs=6642.5 |
| Treatment-emergent AEs | E/100 PY | E/100 PY | E/100 PY | E/100 PY |
| Any AE | 266.4 | 267.1 | 297.3 | 225.1 |
| Serious AE | 18.7 | 19.3 | 15.3 | 15.8 |
| AE Leading to Discontinuation of Study Drug |
2.7 | 4.5 | 2.4 | 2.8 |
| Death | 0 | 0 | 0 | 0.1 |
| AEs of Special Interest | E/100 PY | E/100 PY | E/100 PY | E/100 PY |
| Infections | ||||
| Infections | 50.2 | 60.8 | 60.3 | 54.7 |
| Serious Infection | 2.7 | 7.4 | 2.4 | 2.6 |
| Opportunistic Infection (Excluding TB/Herpes Zoster) | 0 | 0.7 | 0 | 0.3 |
| Active Tuberculosis (TB) | 0 | 0 | 0 | <0.1 |
| Herpes Zoster | 1.3 | 0 | 0.8 | 0.7 |
| Malignancy | ||||
| NMSC | 0 | 0 | 0.8 | 0.2 |
| Malignancy (Excluding NMSC) | 0 | 0 | 0 | 0.4 |
| Cardiovascular Events | ||||
| Adjudicated MACE* | 0 | 0.7 | 0.8 | 0.2 |
| Other | ||||
| Hypersensitivity (Serious Events Only) | 0 | 0 | 0 | <0.1 |
| Adjudicated Anaphylactic Reaction | 0 | 0 | 0 | 0 |
| Hepatic Events | 4.7 | 6.7 | 2.4 | 4.1 |
| Injection Site Reactions | 10.0 | 13.4 | 4.8 | 5.0 |
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.1
In the treatment of Crohn’s, drug-induced liver injury during induction has been reported. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin levels at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management.1
In the Crohn's 52-week maintenance study, the most common adverse reactions (>3% of patients and at a higher rate than placebo) include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.1
FORTIFY OLE STUDY DESIGN: An ongoing, two arm, multicenter, open-label extension of Phase 3 studies evaluating the long-term efficacy and safety of SKYRIZI (180 mg or 360 mg SC). Patients who achieved clinical response† in ADVANCE or MOTIVATE at Week 12 and completed the 52-week FORTIFY maintenance period were eligible to participate.10
Long-term safety data presented in Crohn’s trial include patients with varying lengths of treatment exposure.3
LONG-TERM SAFETY: Includes data for patients who received ≥1 dose of SKYRIZI in Phase 1, 2, and 3 Crohn’s studies.10
Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100)† to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.3
* Defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.3
† Clinical response was defined as a reduction of CDAI score ≥100 points from baseline.1
AEs=adverse events; CDAI=Crohn’s disease activity index; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PYs=patient-years; SC=subcutaneous; TB=tuberculosis.
MOST COMMON ADVERSE REACTIONS
Most Common Adverse Reactions
Adverse reactions reported in ≥3% of patients and at a higher rate than placebo1
Induction: ADVANCE & MOTIVATE Crohn’s at Week 12
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| SKYRIZI 600 mg IV* N=620 |
Placebo N=432 |
|
|---|---|---|
| Adverse Drug Reactions | n (%) | n (%) |
| Upper Respiratory Infections† | 66 (10.6) | 40 (9.3) |
| Headache‡ | 41 (6.6) | 24 (5.6) |
| Arthralgia | 31 (5.0) | 19 (4.4) |
Maintenance: FORTIFY Crohn’s at Week 52
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| SKYRIZI 180 mg SC§ N=155 |
SKYRIZI 360 mg SC§ N=142 |
Placebo N=143 |
||
|---|---|---|---|---|
| Adverse Drug Reactions | n (%) | n (%) | n (%) | |
| Arthralgia | 13 (8.4) | 13 (9.2) | 12 (8.4) | |
| Abdominal Pain|| | 9 (5.8) | 12 (8.5) | 6 (4.2) | |
| Injection Site Reactions¶# | 7 (4.5) | 8 (5.6) | 4 (2.8) | |
| Anemia | 7 (4.5) | 7 (4.9) | 6 (4.2) | |
| Pyrexia | 4 (2.6) | 7 (4.9) | 4 (2.8) | |
| Back pain | 3 (1.9) | 6 (4.2) | 3 (2.1) | |
| Arthropathy | 1 (0.6) | 5 (3.5) | 2 (1.4) | |
| Urinary Tract Infection | 1 (0.6) | 5 (3.5) | 4 (2.8) | |
Adverse reactions reported in ≥3% of patients in induction studies and in the maintenance study and at a higher rate than placebo.1
Adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
* SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8.1
† Includes influenza-like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis, tonsillitis, and upper respiratory tract inflammation.1
‡ Headache includes headache and tension headache.1
§ SKYRIZI 180 mg or 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.1
| Includes abdominal pain, abdominal pain upper, and abdominal pain lower.1
¶ Includes injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection site warmth, injection site pain, injection site hypersensitivity, and injection site reaction.1
# Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject for the rate calculations.1
IV=intravenous; SC=subcutaneous; UC=ulcerative colitis.
INSPIRE UC at Week 12*
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| SKYRIZI 1200 mg IV N=712 |
Placebo N=383 |
|
|---|---|---|
| Adverse Drug Reactions | n (%) | n (%) |
| Arthralgia | 23 (3.2) | 5 (1.3) |
COMMAND UC at Week 52
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| SKYRIZI 180 mg SC† N=170 |
SKYRIZI 360 mg SC† N=177 |
Placebo N=173 |
|
|---|---|---|---|
| Adverse Drug Reactions | n (%) | n (%) | n (%) |
| Arthralgia | 9 (5.3) | 17 (9.6) | 8 (4.6) |
| Pyrexia | 8 (4.7) | 7 (4.0) | 6 (3.5) |
| Injection Site Reactionsठ| 5 (2.9) | 5 (2.8) | 2 (1.2) |
| Rash|| | 7 (4.1) | 1 (0.6) | 3 (1.7) |
Adverse reactions reported in ≥3% of patients in induction studies and in the maintenance study and at a higher rate than placebo.1
Adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
† SKYRIZI 180 mg or 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.1
‡ Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject for the rate calculations.1
§ Includes application site pain, injection site erythema, injection site pain, injection site pruritus, and injection site reaction.1
|| Includes rash and rash macular.1
IV=intravenous; SC=subcutaneous; UC=ulcerative colitis.
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