Trial Outcomes & Findings for Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT02203851)

NCT ID: NCT02203851

Last Updated: 2019-11-08

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

Results posted on

2019-11-08

Participant Flow

Analyses were performed using the intent-to-treat (ITT) population defined as all participants who received at least 1 dose of study drug. As predefined, the demographics, disposition and safety results were summarized for ITT population. Efficacy results were summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).

Participants completing lead-in study and met eligibility for this study were enrolled; demographic/disposition were not collected by dose level. Some participants in extension study had dose escalation due to lack of efficacy, predefined selected safety analysis were broken down by groups: participants remaining at 90mg and those receiving 180mg.

Participant milestones

Participant milestones
Measure	Risankizumab 90 mg or 180 mg Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Study STARTED	110
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Risankizumab 90 mg or 180 mg Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	6
Overall Study Other	1

Baseline Characteristics

Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risankizumab 90 mg or 180 mg n=110 Participants Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Age, Continuous	49.0 years STANDARD_DEVIATION 13.04 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

Population: Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=23 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=87 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	18 participants	—	—	67 participants

PRIMARY outcome

Population: Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=23 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=87 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Number of Participants With Drug-related TEAEs	3 participants	—	—	12 participants

PRIMARY outcome

Population: Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=23 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=87 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)	2 participants	—	—	12 participants

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).

Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period	77.8 percentage of participants Interval 62.1 to 93.5	71.9 percentage of participants Interval 56.3 to 87.5	74.1 percentage of participants Interval 57.5 to 90.6	72.7 percentage of participants Interval 54.1 to 91.3

SECONDARY outcome

Timeframe: Week 48

Population: ITT Population summarized by the 4 treatment groups from the lead-in study

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period	70.4 percentage of participants Interval 53.1 to 87.6	68.8 percentage of participants Interval 52.7 to 84.8	66.7 percentage of participants Interval 48.9 to 84.4	63.6 percentage of participants Interval 43.5 to 83.7

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT population summarized by the 4 treatment groups from the lead-in study

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period	96.3 percentage of participants Interval 89.2 to 100.0	100.0 percentage of participants Interval 100.0 to 100.0	100.0 percentage of participants Interval 100.0 to 100.0	95.5 percentage of participants Interval 86.8 to 100.0

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT population summarized by the 4 treatment groups from the lead-in study

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period	92.6 percentage of participants Interval 82.7 to 100.0	90.6 percentage of participants Interval 80.5 to 100.0	96.3 percentage of participants Interval 89.2 to 100.0	86.4 percentage of participants Interval 72.0 to 100.0

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: ITT population summarized by the 4 treatment groups from the lead-in study

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period	55.6 percentage of participants Interval 36.8 to 74.3	50.0 percentage of participants Interval 32.7 to 67.3	55.6 percentage of participants Interval 36.8 to 74.3	54.5 percentage of participants Interval 33.7 to 75.4

SECONDARY outcome

Timeframe: Week 48

Population: ITT Population summarized by the 4 treatment groups from the lead-in study

Outcome measures

Outcome measures
Measure	Risankizumab 90 mg/Risankizumab n=27 Participants Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg/Risankizumab n=32 Participants Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Ustekinumab/Risankizumab n=27 Participants Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 18 mg/Risankizumab n=22 Participants Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period	63.0 percentage of participants Interval 44.7 to 81.2	56.3 percentage of participants Interval 39.1 to 73.4	55.6 percentage of participants Interval 36.8 to 74.3	54.5 percentage of participants Interval 33.7 to 75.4

Adverse Events

Risankizumab 90 mg

Serious events: 12 serious events

Other events: 46 other events

Deaths: 0 deaths

Risankizumab 180 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Risankizumab 90 mg n=87 participants at risk Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg n=23 participants at risk Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had \< PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Bronchitis	5.7% 5/87 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	8.7% 2/23 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Influenza	8.0% 7/87 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Nasopharyngitis	18.4% 16/87 • Number of events 33 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	13.0% 3/23 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Sinusitis	3.4% 3/87 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	13.0% 3/23 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Tooth abscess	6.9% 6/87 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Upper respiratory tract infection	12.6% 11/87 • Number of events 16 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	17.4% 4/23 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Urinary tract infection	9.2% 8/87 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Injury, poisoning and procedural complications Muscle strain	2.3% 2/87 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	8.7% 2/23 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 9/87 • Number of events 10 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	8.7% 2/23 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 4/87 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	8.7% 2/23 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Skin and subcutaneous tissue disorders Dermal cyst	2.3% 2/87 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	8.7% 2/23 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Skin and subcutaneous tissue disorders Dermatitis contact	2.3% 2/87 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	13.0% 3/23 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Vascular disorders Hypertension	6.9% 6/87 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.

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Measure	Risankizumab 90 mg n=87 participants at risk Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.	Risankizumab 180 mg n=23 participants at risk Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had \< PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study.
Cardiac disorders Myocardial infarction	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Endocrine disorders Goitre	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Eye disorders Glaucoma	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Eye disorders Macular degeneration	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
General disorders Non-cardiac chest pain	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Cystitis	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Pneumonia	0.00% 0/87 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Pyelonephritis	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Infections and infestations Sepsis	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Injury, poisoning and procedural complications Fall	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Injury, poisoning and procedural complications Lower limb fracture	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Metabolism and nutrition disorders Hypoglycaemia	1.1% 1/87 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/87 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Nervous system disorders Syncope	1.1% 1/87 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Nervous system disorders Transient ischaemic attack	2.3% 2/87 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	0.00% 0/23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Nervous system disorders Ulnar neuritis	0.00% 0/87 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Psychiatric disorders Psychotic disorder	0.00% 0/87 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/87 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.	4.3% 1/23 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.