SAFETY PROFILE FOR SKYRIZI

Consistent Safety Profile Observed up to ~10 Years in Crohn’s and UC^2-9

SKYRIZI SAFETY PROFILE

SKYRIZI Safety Profile

INDUCTION

MAINTENANCE

LONG-TERM DATA

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Adverse Events (AEs)	SKYRIZI 720 mg SC N=191	Placebo N=98	SKYRIZI 600 mg IV* N=620	Placebo N=432	SKYRIZI 1200 mg IV^† N=712	Placebo N=383
	Crohn's Week 12				UC Week 12
	AFFIRM		ADVANCE & MOTIVATE (Pooled Induction Trial Data)		INSPIRE
Treatment-emergent AEs	%	%	%	%	%	%
Any AE	42.4	59.2	54.7	63.4	42.3	51.7
Serious AE	0.5	3.1	6.6	15.5	2.7	10.2
AE Leading to Discontinuation of Study Drug	0	1.0	2.1	8.6	0.8	4.4
Death	0	0	0	0.5	0.1	0
AEs of Special Interest	%	%	%	%	%	%
Infections
Infections	12.6	17.3	19.7	24.8	14.9	16.7
Serious Infection	0	0	1.0	3.7	0.7	1.0
Opportunistic Infection (Excluding TB/Herpes Zoster)	0	0	0	0.7	0	0
Active Tuberculosis (TB)	0	0	0.2	0.2	0	0
Herpes Zoster	0	0	0.3	0.2	0.3	0.3
Malignancy
NMSC	0	0	0	0	0	0
Malignancy (Excluding NMSC)	0	0	0	0	0	0.8
Cardiovascular Events
Adjudicated MACE^‡	0	0	0	0	0	0
Other
Hypersensitivity (Serious Events Only)	0	0	0.2	0.2	0	0.3
Adjudicated Anaphylactic Reaction	0	0	0	0	0	0
Hepatic Events	0.5	5.1	1.6	1.6	1.5	4.2
Injection Site Reactions	2.1	1.0	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 SC and IV 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

In maintenance, the most common adverse reactions (~3%) associated with SKYRIZI in Crohn’s were arthralgia, abdominal pain,^|| injection site reactions,^¶ anemia, pyrexia, back pain, arthropathy, and urinary tract infection, and in UC were arthralgia, pyrexia, injection site reactions,^¶# and rash.¹**

The overall safety profile observed for AFFIRM Induction Study was generally consistent with IV induction studies.

*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).⁴

^†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.⁵

^§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

^||Includes abdominal pain, abdominal pain upper, and abdominal pain lower.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

AEs=adverse events; IV=intravenous; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; SC=subcutaneous; TB=tuberculosis.

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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
	FORTIFY Crohn's at Week 52				COMMAND UC at Week 52*
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 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.¹⁰

Placebo (Induction Responders): Patients who achieved clinical response^¶ to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.¹

*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.⁸

^†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.⁵

^‡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).⁵

^§In the Crohn’s long-term safety study, defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.⁵

^||In the Crohn’s long-term safety study, most hepatic events were liver enzyme elevations; none of the events were serious.^5,11

^¶Clinical response was defined as a reduction of CDAI score ≥100 points from baseline and a decrease in modified Mayo Score ≥2 and ≥30% from baseline, and decrease in RBS ≥1 or an absolute RBS ≤1.¹

AEs=adverse events; CDAI=Crohn’s disease activity index; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PYs=patient-years; RBS=rectal bleeding score; SC=subcutaneous; TB=tuberculosis.

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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	SKYRIZI 180 mg SC N=170, PYs=163.4	SKYRIZI 360 mg SC N=177, PYs=159.0	Placebo (induction responders) N=143, PYs=124.4	SKYRIZI 180/360 mg SC N=1523, PYs=4255.5
	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	COMMAND UC at Week 52*			Long-Term Safety in UC Max Exposure: 6.1 yrs Median Exposure: 2.74 yrs Mean Exposure: 2.61 yrs
Treatment-emergent AEs	%	%	%	E/100 PY	%	%	%	E/100 PY
Any AE	69	70	71	225.1	70	70	75	174.6
Serious AE	11	13	10	15.8	4	5	8	8.1
AE Leading to Discontinuation of Study Drug	2	3	2	2.8	2	2	1	2.6
Death	0	0	0	0.1	0	0.6	0	0.1
AEs of Special Interest	E/100 PY	E/100 PY	E/100 PY	E/100 PY	E/100 PY	E/100 PY	E/100 PY	E/100 PY
Infections
Infections	50.2	60.8	60.3	54.7	69.1	59.1	60.4	51.9
Serious Infection	2.7	7.4	2.4	2.6	1.2	0.6	1.9	1.7
Opportunistic Infection (Excluding TB/Herpes Zoster)^†	0	0.7	0	0.3	0	0.6	0	0.1
Active Tuberculosis (TB)	0	0	0	<0.1	0	0	0	0
Herpes Zoster	1.3	0	0.8	0.7	0.6	0.6	1.9	0.5
Malignancy
NMSC	0	0	0.8	0.2	0	0	0.6	0.4
Malignancy (Excluding NMSC)^‡	0	0	0	0.4	0	1.3	0	0.5
Cardiovascular Events
Adjudicated MACE^§	0	0.7	0.8	0.2	0	0	0	0.1
Other
Hypersensitivity (Serious Events Only)	0	0	0	<0.1	0	0	0	<0.1
Adjudicated Anaphylactic Reaction	0	0	0	0	0	0	0	<0.1
Hepatic Events^\|\|	4.7	6.7	2.4	4.1	1.8	11.3	1.9	2.5
Injection Site Reactions	10.0	13.4	4.8	5.0	7.3	6.3	1.9	3.9

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.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

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.¹²

COMMAND OLE STUDY DESIGN: An ongoing open-label extension study that evaluated the long-term efficacy and safety of SKYRIZI that included patients from the COMMAND maintenance study. Patients in the COMMAND maintenance study achieved clinical response per modified Mayo Score with SKYRIZI in the INSPIRE induction study.¹³

Long-term safety data presented include patients with varying lengths of treatment exposure.⁵

LONG-TERM SAFETY: Includes data for patients who received ≥1 dose of SKYRIZI in Phase 1, 2, and 3 Crohn’s studies.^12,13

Placebo (Induction Responders): Patients who achieved clinical response^¶ to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.¹

*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.⁸

^†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.⁵

^§In the Crohn’s long-term safety study, defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.⁵

^||In the Crohn’s long-term safety study, most hepatic events were liver enzyme elevations; none of the events were serious.^5,11

MOST COMMON ADVERSE REACTIONS

Most Common Adverse Reactions

Adverse reactions reported in ≥3% of patients and at a higher rate than placebo¹

CROHN’S

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)

The overall safety profile observed for AFFIRM was generally consistent with ADVANCE and MOTIVATE.

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 Reactions^‡§	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

*Data are integrated from a Phase 2b and a Phase 3 clinical trial in UC.

^†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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AFFIRM	SKYRIZI 720 mg SCN=180	Placebo N=94
Male, n (%)	103 (57.2)	53 (56.4)
Age (years), mean (SD)	40 (14.1)	38.6 (14.8)
Disease duration (years), mean (SD)	8.7 (9.0)	7.1 (8.0)
Disease location
Ileal only, n (%)	21 (11.7)	15 (16.0)
Colonic only, n (%)	58 (32.2)	30 (31.9)
Ileal-colonic, n (%)	101 (56.1)	49 (52.1)
hs-CRP (mg/L), median (min, max)	5.35 (0.2, 120.5)	5.15 (0.2, 129.4)
CDAI, mean (SD)	311.9 (54.3)	314.2 (55.5)
SES-CD, mean (SD)	13.3 (6.5)	12.7 (6.5)
Corticosteroid use, n (%)	43 (23.9)	25 (26.6)
*Advanced therapy failure history**
0, n (%)	65 (36.1)	33 (35.1)
1, n (%)	58 (32.2)	30 (31.9)
>1, n (%)	57 (31.7)	31 (33.0)

ADVANCE	SKYRIZI 600 mg IVN=336	Placebo N=175
Male, n (%)	189 (56)	88 (50)
Age (years), mean (SD)	38.3 (13.3)	37.1 (13.4)
Disease duration (years), mean (SD)	9.0 (8.8)	8.2 (7.1)
Disease location
Ileal only, n (%)	52 (15)	19 (11)
Colonic only, n (%)	115 (34)	70 (40)
Ileal-colonic, n (%)	169 (50)	86 (49)
hs-CRP (mg/L), median (IQR)	7.3 (2.8-21.8)	8.4 (2.8-21.9)
CDAI, mean (SD)	311.2 (62.4)	319.2 (59.4)
SES-CD, mean (SD)	14.7 (7.7)	13.8 (6.8)
Corticosteroid use, n (%)	102 (30)	50 (29)
*Advanced therapy failure history**
0, n (%)	141 (42)	78 (45)
1, n (%)	100 (30)	41 (23)
>1, n (%)	95 (28)	56 (32)

MOTIVATE	SKYRIZI 600 mg IVN=191	Placebo N=187
Male, n (%)	92 (48)	99 (53)
Age (years), mean (SD)	40.2 (13.6)	39.3 (13.5)
Disease duration (years), mean (SD)	10.9 (7.7)	12.5 (9.7)
Disease location
Ileal only, n (%)	33 (17)	26 (14)
Colonic only, n (%)	75 (39)	73 (39)
Ileal-colonic, n (%)	83 (43)	88 (47)
hs-CRP (mg/L), median (IQR)	9.3 (3.5-23.0)	9.4 (3.6-28.2)
CDAI, mean (SD)	310.7 (63.6)	319.6 (69.8)
SES-CD, mean (SD)	14.4 (7.6)	15.0 (8.1)
Corticosteroid use, n (%)	65 (34)	68 (36)
*Advanced therapy failure history**
0, n (%)	0	0
1, n (%)	92 (48)	88 (47)
>1, n (%)	99 (52)	99 (53)

FORTIFY	SKYRIZI 180 mg SC N=135	SKYRIZI 360 mg SC N=117	Placebo (Induction Responders^†)N=130
Baseline of Induction (ADVANCE, MOTIVATE)
Male, n (%)	62 (45.9)	67 (57.3)	72 (55.4)
Age (years), mean (SD)	39.2 (14.7)	36.2 (12.6)	38.0 (12.8)
Disease duration (years), mean (SD)	10.6 (10.2)	8.6 (7.1)	9.6 (8.2)
Disease location
Ileal only, n (%)	12 (9)	13 (11)	18 (14)
Colonic only, n (%)	63 (47)	52 (44)	49 (38)
Ileal-colonic, n (%)	60 (44)	52 (44)	63 (49)
Baseline immunomodulator use, n (%)	37 (27.4)	34 (29.1)	33 (25.4)
Baseline steroid use, n (%)	47 (34.8)	36 (30.8)	40 (30.8)
*Advanced therapy failure history**
0, n (%)	40 (29.6)	34 (29.1)	31 (23.8)
1, n (%)	34 (25.2)	42 (35.9)	49 (37.7)
>1, n (%)	61 (45.2)	41 (35.0)	50 (38.5)
Baseline CDAI, mean (SD)	327.6 (68.2)	316.2 (59.6)	314.2 (64.2)
Baseline SES-CD, mean (SD)	14.9 (7.2)	14.3 (7.0)	14.1 (7.1)
Baseline SF, mean (SD)	6.2 (3.1)	5.9 (2.7)	5.8 (2.7)
Baseline APS, mean (SD)	2.0 (0.4)	1.9 (0.5)	1.9 (0.5)
Baseline FCP (mg/kg), median (min, max)	1666.0 (30, 28800)	1622.0 (30, 14649)	904.0 (30, 11378)
Baseline hs-CRP (mg/L), median (min, max)	8.7 (0.4, 151)	10.6 (0.3, 129)	7.9 (0.3, 181)
Week 0 of Maintenance
CDAI at Week 0, mean (SD)	117.6 (66.8)	125.4 (62.7)	111.6 (69.5)
SES-CD at Week 0, mean (SD)	7.8 (6.4)	8.3 (7.3)	7.3 (6.4)
SF at Week 0, mean (SD)	2.1 (1.9)	1.9 (1.7)	1.4 (1.7)
APS at Week 0, mean (SD)	0.6 (0.5)	0.6 (0.5)	0.6 (0.5)
FCP (mg/kg) at Week 0, median (min, max)	361 (30, 28800)	485.5 (30, 14804)	300.0 (30, 22912)
hs-CRP (mg/L) at Week 0, median (min, max)	3.7 (0, 48)	4.0 (0, 258)	3.6 (0, 42)

Baseline Characteristics	SKYRIZI 1200 mg IV N=646	PlaceboN=320
Female, %	41	38
Race (white), %	71	67
Median age, years	40	42
Median disease duration, years	6	6
Median weight, kg	70	71
Disease Extent
Left sided, %	48	46
Extensive/pancolitis, %	51	53
Median fecal calprotectin, mg/kg	1530 (n=598)	1624 (n=298)
Median hs-CRP, mg/L	3.4 (n=634)	4.0 (n=313)
Baseline immunosuppressant use, %	17	16
Baseline aminosalicylates use, %	73	73
Baseline corticosteroid use, %	36	35
Baseline Advanced Therapy Experience
Advanced therapy naïve,^a %	49	48
Advanced therapy failure,^b %	51	53
1	24	25
2	17	17
3+	11	11
Prior TNF use, %	86	84
Prior vedolizumab use, %	54	52
Prior JAK use, %	16	22
Baseline Modified Mayo Score
≤7, %	63	63
>7, %	38	37
Mean Mayo Endoscopy Subscore	2.7	2.7

SAFETY PROFILE FOR SKYRIZI

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Consistent Safety Profile Observed up to ~10 Years in Crohn’s and UC^2-9

SKYRIZI SAFETY PROFILE

The overall safety profile observed for AFFIRM Induction Study was generally consistent with IV induction studies.

Most Common Adverse Reactions

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IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

SAFETY PROFILE FOR SKYRIZI

Jump to:

Consistent Safety Profile Observed up to ~10 Years in Crohn’s and UC2-9

SKYRIZI SAFETY PROFILE

The overall safety profile observed for AFFIRM Induction Study was generally consistent with IV induction studies.

Most Common Adverse Reactions

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IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

Consistent Safety Profile Observed up to ~10 Years in Crohn’s and UC^2-9

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹