Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis (NCT NCT03347110)
NCT ID: NCT03347110
Last Updated: 2023-12-01
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.
COMPLETED
PHASE2
184 participants
From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
2023-12-01
Participant Flow
The study started to enroll study participants in November 2017 and concluded in October 2020.
Participant Flow refers to the Safety Set. Participants who completed the study PA0008 (NCT02969525) were eligible to enroll in study PA0009. A total of 184 participants from PA0008 signed the Informed Consent Form and were enrolled in PA0009 study. Among 184 participants, 1 participant did not receive treatment and was not included in analysis.
Participant milestones
| Measure |
Bimekizumab 160 mg
Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.
|
|---|---|
|
Overall Study
STARTED
|
183
|
|
Overall Study
COMPLETED
|
161
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Bimekizumab 160 mg
Participants received bimekizumab (BKZ) 160 milligrams (mg) as a subcutaneous (sc) injection every 4 weeks (Q4W) for up to 100 weeks.
|
|---|---|
|
Overall Study
Other (Participant is incarcerated)
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event, non-fatal
|
9
|
Baseline Characteristics
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Bimekizumab 160 mg (SS)
n=183 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the Safety Set (SS) which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
165 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
179 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)Population: The Safety Set (SS) consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=183 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
80.9 percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)Population: The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=183 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)Population: The SS consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=183 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
The ACR20 response rate was based on 20% or greater improvement relative to Baseline of PA0008 in the following measures: Tender Joint Count (TJC) based on 78 joints, Swollen Joint Count (SJC) based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA), Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA), Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP), Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI), Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP). Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=181 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008
|
79.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: The FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
The ACR50 response rate was based on 50% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=181 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008
|
64.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: The FAS consisted of all enrolled participants who received at least 1 dose of study medication in PA0009 and had a valid measurement for at least 1 efficacy variable after PA0009 entry visit.
The ACR70 response rate was based on 70% or greater improvement relative to Baseline of PA0008 in the following measures: TJC based on 78 joints, SJC based on 76 joints; 3 of the 5 remaining core set measures: Disease activity as assessed by PGADA, Disease activity as assessed by PhGADA, Pain as assessed by PtAAP, Physical function as assessed by HAQ-DI, Acute phase response as assessed by hs CRP. Participants for whom ACR could not be derived due to missing data were counted as non-responders as per NRI analysis.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=181 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008
|
47.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: Subset of study participants in the FAS with Enthesitis at PA0008 Baseline (MASES\>0).
The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process). Each item was scored as 0 = not tender or 1 = tender and then were summed for a possible score of 0 to 13, with higher scores indicating worse enthesitis. If 7 or more items were available, MASES was calculated by dividing the summed score with the number of assessments and multiplying the result by 13. If less than 7 items were available, MASES was treated as missing.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=95 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008
|
-2.99 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: Subset of study participants in the FAS with Dactylitis at PA0008 Baseline (LDI\>0).
Presence of dactylitis was assessed using the LDI basic which evaluated for a greater than or equal to (\>=) 10% difference in the circumference of the digit compared to the opposite digit and was then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present). The results from each digit with dactylitis were summed to produce a final score. For the final score, the minimum value for LDI is zero and there is no maximum value. A low score indicates less dactylitis symptoms. A score of zero is considered dactylitis free. Observed values have been reported in this outcome measure.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=45 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008
|
-54.31 score on a scale
Standard Deviation 67.09
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: Subset of study participants in FAS with body surface area (BSA) affected by psoriasis of \>=3% at PA0008 Baseline.
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with psoriasis (PSO) for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the Final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using least observation carried forward (LOCF) for any visits where the corresponding BSA has not increased compared to the preceding visit.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=120 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of PA0008, Week 48Population: Subset of study participants in FAS with BSA affected by psoriasis of \>=3% at PA0008 Baseline.
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline of PA0008. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. For the final score, minimum possible PASI value is 0= no disease, maximum value is 72= maximal disease. Missing PASI responses were imputed using LOCF for any visits where the corresponding BSA has not increased compared to the preceding visit.
Outcome measures
| Measure |
Bimekizumab 160 mg (SS)
n=120 Participants
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008
|
80.0 percentage of participants
|
Adverse Events
Bimekizumab 160 mg (SS)
Serious adverse events
| Measure |
Bimekizumab 160 mg (SS)
n=183 participants at risk
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
2/183 • Number of events 2 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Chronic sinusitis
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.1%
2/183 • Number of events 2 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.55%
1/183 • Number of events 1 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
Other adverse events
| Measure |
Bimekizumab 160 mg (SS)
n=183 participants at risk
Participants received BKZ 160 mg as a sc injection Q4W for up to 100 weeks. Participants formed the SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
|
|---|---|
|
Infections and infestations
Oral candidiasis
|
7.1%
13/183 • Number of events 23 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Bronchitis
|
6.0%
11/183 • Number of events 15 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
20/183 • Number of events 29 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
19/183 • Number of events 24 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Pharyngitis
|
5.5%
10/183 • Number of events 11 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Infections and infestations
Sinusitis
|
5.5%
10/183 • Number of events 10 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
6.6%
12/183 • Number of events 13 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.7%
14/183 • Number of events 15 • From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A TEAE was defined as an event with onset date on or after the start date of study medication in PA0009.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60