Trial Outcomes & Findings for Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis (NCT NCT03478787)

Last Updated: 2021-07-13

Results Overview

The 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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

327 participants

Primary outcome timeframe

Week 16

Results posted on

2021-07-13

Participant Flow

A total of 327 participants were randomized from 53 sites across 9 countries including Canada, France, Germany, Italy, The Netherlands, Poland, Spain, the United Kingdom, and the United States.

Eligible participants were randomized to receive risankizumab or secukinumab in a 1:1 ratio. The randomization was stratified by weight (≤ 100 kg vs. \> 100 kg) and prior systemic biologic for psoriasis (0 vs. ≥ 1).

Participant milestones

Participant milestones
Measure	Secukinumab Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Overall Study STARTED	163	164
Overall Study COMPLETED	134	151
Overall Study NOT COMPLETED	29	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Overall Study Adverse Event	5	1
Overall Study Protocol Violation	3	0
Overall Study Lack of Efficacy	7	1
Overall Study Lost to Follow-up	9	5
Overall Study Withdrawal by Subject	2	6
Overall Study Other, Not Specified	3	0

Baseline Characteristics

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).	Total n=327 Participants Total of all reporting groups
Age, Customized < 40 years	60 Participants n=5 Participants	50 Participants n=7 Participants	110 Participants n=5 Participants
Age, Customized 40 to < 65 years	81 Participants n=5 Participants	99 Participants n=7 Participants	180 Participants n=5 Participants
Age, Customized >/= 65 years	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	52 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	112 Participants n=7 Participants	213 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	37 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=5 Participants	127 Participants n=7 Participants	256 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	144 Participants n=5 Participants	151 Participants n=7 Participants	295 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Intent to Treat (ITT) analysis set: all participants who were randomized at Baseline. Non-responder imputation (NRI) was used for missing data.

Outcome measures

Outcome measures
Measure	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16	65.6 percentage of participants	73.8 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.

The 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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. 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	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Percentage of Participants With a PASI 90 at Week 52	57.1 percentage of participants	86.6 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.

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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. 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	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52	39.9 percentage of participants	65.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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 3; 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.

Outcome measures

Outcome measures
Measure	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52	58.3 percentage of participants	87.8 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.

The 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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. 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	Secukinumab n=163 Participants Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.	Risankizumab n=164 Participants Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52	69.9 percentage of participants	89.6 percentage of participants

Adverse Events

Secukinumab

Serious events: 6 serious events

Other events: 71 other events

Deaths: 0 deaths

Risankizumab

Serious events: 9 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Secukinumab n=163 participants at risk Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.	Risankizumab n=164 participants at risk Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug .
Gastrointestinal disorders DIARRHOEA	5.5% 9/163 • Number of events 12 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	5.5% 9/164 • Number of events 11 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Infections and infestations BRONCHITIS	6.7% 11/163 • Number of events 11 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	1.8% 3/164 • Number of events 3 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Infections and infestations NASOPHARYNGITIS	16.6% 27/163 • Number of events 38 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	21.3% 35/164 • Number of events 48 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.6% 14/163 • Number of events 20 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	12.8% 21/164 • Number of events 25 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Musculoskeletal and connective tissue disorders ARTHRALGIA	6.1% 10/163 • Number of events 13 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	5.5% 9/164 • Number of events 12 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Nervous system disorders HEADACHE	9.2% 15/163 • Number of events 27 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	5.5% 9/164 • Number of events 20 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Vascular disorders HYPERTENSION	3.1% 5/163 • Number of events 5 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	5.5% 9/164 • Number of events 10 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Secukinumab n=163 participants at risk Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.	Risankizumab n=164 participants at risk Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug .
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Cardiac disorders ARRHYTHMIA SUPRAVENTRICULAR	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Endocrine disorders BASEDOW'S DISEASE	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Gastrointestinal disorders COLITIS ULCERATIVE	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Hepatobiliary disorders CHOLELITHIASIS	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Infections and infestations URINARY TRACT INFECTION	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	1.2% 2/164 • Number of events 2 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Injury, poisoning and procedural complications OVERDOSE	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HISTIOCYTIC NECROTISING LYMPHADENITIS	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Nervous system disorders TOXIC ENCEPHALOPATHY	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Psychiatric disorders SUICIDE ATTEMPT	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/163 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.61% 1/164 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Skin and subcutaneous tissue disorders RASH PRURITIC	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
Vascular disorders ARTERIOSCLEROSIS	0.61% 1/163 • Number of events 1 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).	0.00% 0/164 • Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).