Trial Outcomes & Findings for Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (NCT NCT04632927)
NCT ID: NCT04632927
Last Updated: 2025-10-16
Results Overview
The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders
COMPLETED
PHASE3
119 participants
Baseline, Week 28
2025-10-16
Participant Flow
Patients were randomized in 28 study sites across Germany
A total of 144 patients overall were screened and 25 patients failed screening, while 119 patients completed the screening period successfully and underwent randomization
Participant milestones
| Measure |
Secukinumab
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
63
|
|
Overall Study
COMPLETED
|
56
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
10
|
Reasons for withdrawal
| Measure |
Secukinumab
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Loss of efficacy
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Subject decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Baseline characteristics by cohort
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
53.5 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
55 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 28Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28
|
32 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 90% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28
|
27 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis.
The patient's level of pain was evaluated using a horizontal Visual Analogue Scale (VAS), on which individuals marked their pain intensity with a vertical tick. The scale ranged from 0 mm (indicating "no pain") to 100 mm (indicating "unbearable pain"). The change in the patient's pain assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=58 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Patient's Assessment of Pain on VAS at Week 28
|
-27.1 Score on a Scale
Standard Deviation 25.8
|
-16.4 Score on a Scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis.
Tender joint count (TJC) 68 was a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The 68 joints assessed for tenderness included the 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 hips, 2 knees, 2 talo¬tibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in TJC68 at Week 28 was assessed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=59 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Tender Joint Count (TJC) 68 at Week 28
|
-9.6 Score on a Scale
Standard Deviation 11.9
|
-7.6 Score on a Scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis.
Swollen Joint Count (SJC) 66 was a method of assessing joint inflammation. The number of swollen joints was determined by examining 66 joints and identifying those with visible or palpable swelling suggestive of synovitis. The 66 joints assessed for swelling included the 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 knees, 2 talotibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in SJC66 at Week 28 was assessed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=59 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28
|
-6.8 Score on a Scale
Standard Deviation 6.3
|
-5.3 Score on a Scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Bseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The PASI was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved 100% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Number of Patients Achieving PASI 100 at Week 28
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 75% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Number of Patients Achieving PASI 75 at Week 28
|
34 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis
The patient's global assessment of disease activity was performed using a 100 mm (VAS) ranging from 0 (='very good') to 100 (='very poor') after the question 'Considering all the ways Psoriatic Arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are today'. The change in the patient's global assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=57 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Disease Activity on VAS
|
-26.0 Score on a Scale
Standard Deviation 21.8
|
-15.5 Score on a Scale
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis
The patient's assessment of psoriasis and arthritis was performed using a 100 mm VAS ranging from 0 (='Excellent') to 100 (='Poor') after the question 'Considering all the ways PSORIASIS and ARTHRITIS affects you, please indicate with a vertical mark through the horizontal line how well you are doing over the past week' The change in the patient's global assessment of psoriasis and arthritis disease activity on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=58 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS
|
-28.1 Score on a Scale
Standard Deviation 23.6
|
-16.2 Score on a Scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
MDA was a composite endpoint used to assess low disease activity in patients with psoriatic arthritis and psoriasis. A patient was considered to have achieved MDA if they met at least 5 of the following 7 criteria: * TJC (0-68)≤1 * SJC (0-66 joints)≤1 * PASI ≤1 \[the total score ranged from 0 (no disease) to 72 (maximal disease)\] or body surface area≤3% * Patient's pain VAS ≤ 15 mm on a 100 mm scale, where 0 ="no pain" and 100= "pain as severe as can be imagined" * Patient's global assessment of disease activity (PtGA) ≤ 20 mm on a 100 mm scale, where 0 represented the lowest level of disease activity and 100 the highest * HAQ-DI ≤ 0.5, where 0 represented no difficulty and 3 represented inability to perform activities * Enthesitis count ≤ 1, based on the Leeds Enthesitis Index, where 0 indicated no tenderness and 6 indicated tenderness at all assessed tendon insertions The number of participants achieving MDA at Week 28 was assessed. Missing values were imputed as non-responders.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis
The LEI was a validated enthesitis index that used six sites to evaluate enthesitis: the left and right lateral epicondyles of the humerus, the left and right proximal Achilles tendon insertions, and the left and right medial femoral condyles.Each site was scored as 0 (non-tender) or 1 (tender), resulting in a total score ranging from 0 to 6. A higher score reflected a greater burden of enthesitis. The change in the LEI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in enthesitis severity
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=59 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in the Leeds Enthesitis Index (LEI)
|
-0.9 Score on a Scale
Standard Deviation 1.8
|
-0.5 Score on a Scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis
The LDI was used to quantitatively assess dactylitis by measuring the circumference of affected digits and their corresponding control digits, along with the tenderness of each affected digit. Digits were classified as dactylitic if there was a ≥10% difference in circumference compared to the contralateral digit. When both digits were affected or a contralateral control was unavailable, a standardized reference range was applied. For each dactylitic digit, the ratio of the affected to control circumference was multiplied by a binary tenderness score (1 = tender, 0 = non-tender). The resulting values were summed across all affected digits to calculate the total LDI score. Scores ranged from 0 to 20, with higher scores indicating more severe or widespread dactylitis. The change in the LDI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in dactylitis severity.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=59 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in the Leeds Dactylitis Index (LDI)
|
-9.7 Score on a Scale
Standard Deviation 27.2
|
-7.2 Score on a Scale
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis
The PsAQoL questionnaire was used to assess the impact of psoriatic arthritis on patients' quality of life. The PsAQoL is a validated, disease-specific, self-administered instrument consisting of 20 items with binary response options ("true" or "not true"). Items covered physical, emotional, and social domains, including fatigue, independence, and interpersonal relationships. The total score ranged from 0 to 20, with higher scores indicating greater impairment in quality of life. The change in the PsAQoL score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in health-related quality of life.
Outcome measures
| Measure |
Secukinumab
n=42 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=51 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL)
|
-2.5 Score on a Scale
Standard Deviation 5.1
|
-2.0 Score on a Scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The FACIT-Fatigue Scale was used to assess fatigue and its impact on daily functioning over the previous 7 days. The instrument consisted of 13 self-administered items, each scored on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Very much"). The total score ranged from 0 to 52, with higher scores indicating less fatigue and better functioning. Response was achieved if the score had improved by at least 4 points from baseline. Missing values were imputed as non-responders
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28
|
40 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 28Population: FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization.
The DLQI was used to evaluate the impact of dermatological conditions on patients' quality of life over the previous 7 days. It consisted of 10 self-administered items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment burden. Each item was scored from 0 ("Not at all") to 3 ("Very much"), with a total score ranging from 0 to 30. Higher scores indicated greater impairment. Response was achieved if the absolute score was either 0 or 1. Missing values were imputed as non-responders.
Outcome measures
| Measure |
Secukinumab
n=56 Participants
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24.
|
Ustekinumab
n=63 Participants
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants \>100 kg). One active injection was administered at Baseline, Week 4, and 16.
To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point.
|
|---|---|---|
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28
|
30 Participants
|
32 Participants
|
Adverse Events
Secukinumab- On-Treatment
Ustekinumab - On-Treatment
Secukinumab - Entire Study
Ustekinumab - Entire Study
Serious adverse events
| Measure |
Secukinumab- On-Treatment
n=56 participants at risk
AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks
|
Ustekinumab - On-Treatment
n=63 participants at risk
AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks
|
Secukinumab - Entire Study
n=56 participants at risk
AEs from start of treatment to end of study, assessed up to approximately 36 weeks
|
Ustekinumab - Entire Study
n=63 participants at risk
AEs from start of treatment to end of study, assessed up to approximately 36 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.8%
1/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
Other adverse events
| Measure |
Secukinumab- On-Treatment
n=56 participants at risk
AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks
|
Ustekinumab - On-Treatment
n=63 participants at risk
AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks
|
Secukinumab - Entire Study
n=56 participants at risk
AEs from start of treatment to end of study, assessed up to approximately 36 weeks
|
Ustekinumab - Entire Study
n=63 participants at risk
AEs from start of treatment to end of study, assessed up to approximately 36 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
6.3%
4/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
6.3%
4/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
10.7%
6/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
11.1%
7/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
10.7%
6/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
12.7%
8/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
14.3%
9/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
12.5%
7/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
14.3%
9/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
4/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
7.9%
5/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
9.5%
6/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
6.3%
4/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
0.00%
0/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
6.3%
4/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
7.9%
5/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
7.9%
5/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
4.8%
3/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
4.8%
3/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
3.6%
2/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
6.3%
4/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
9.5%
6/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
3.2%
2/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
3.2%
2/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.4%
3/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
8.9%
5/56 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
1.6%
1/63 • From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER