Infections and infestations
4.3%
4,648 of 107,221 on Bimekizumab
- Nasopharyngitis11.0%
- Oral candidiasis8.9%
- Upper respiratory tract infection6.1%
- Urinary tract infection3.8%
- Pharyngitis3.2%
Bimekizumab Side Effects: What Clinical Trials Show
Hipa.ai Research · Source: ClinicalTrials.gov / AACT · 24 pivotal trials · Last updated:
24
Trials Sourced
6,173
Drug-Arm Patients
1,178
Placebo-Arm Patients
12
Common AEs Reported
6
Head-to-Head Trials
Bimekizumab's safety profile is based on 24 pivotal clinical trials sourced from AACT / ClinicalTrials.gov. Across these studies, the most common adverse event reported was nasopharyngitis, occurring in 11% of patients.
Most common side effects
Top 12 adverse events ranked by drug-arm frequency. Drug % vs placebo % shown when a placebo arm reported the same term. Active-comparator rates from named head-to-head trials shown where available.
| Adverse event | Bimekizumab | Placebo | adalimumab | certolizumab pegol | secukinumab | ustekinumab | Trials |
|---|---|---|---|---|---|---|---|
| Nasopharyngitis Infections and infestations | 11.0% 1,486 / 13,548 | 3.3% 42 / 1,265 | 11.4% 52 / 456 | 24.0% 6 / 25 | 21.1% 156 / 740 | 15.3% 50 / 326 | 21 |
| Oral candidiasis Infections and infestations | 8.9% 1,107 / 12,433 | 0.4% 4 / 1,112 | 0.4% 2 / 456 | 0% 0 / 25 | 2.0% 15 / 740 | 0.3% 1 / 326 | 19 |
| Upper respiratory tract infection Infections and infestations | 6.1% 850 / 13,874 | 4.5% 59 / 1,298 | 5.5% 25 / 456 | 4.0% 1 / 25 | 7.2% 53 / 740 | 7.1% 23 / 326 | 22 |
| Urinary tract infection Infections and infestations | 3.8% 321 / 8,456 | 2.2% 16 / 720 | 2.2% 6 / 276 | — | 3.9% 29 / 740 | 2.1% 7 / 326 | 10 |
| Headache Nervous system disorders | 4.0% 296 / 7,342 | 3.4% 20 / 582 | 0% 0 / 21 | 8.0% 2 / 25 | — | 5.2% 17 / 326 | 11 |
| Diarrhea Gastrointestinal disorders | 3.4% 239 / 7,064 | 2.4% 10 / 415 | 2.8% 5 / 180 | 12.0% 3 / 25 | — | — | 9 |
| Hidradenitis Skin and subcutaneous tissue disorders | 11.6% 210 / 1,818 | 10.8% 18 / 167 | 28.6% 6 / 21 | — | — | — | 3 |
| Hypertension Vascular disorders | 3.4% 193 / 5,607 | 3.0% 11 / 362 | 7.2% 13 / 180 | — | — | 4.6% 15 / 326 | 9 |
| Psoriasis Skin and subcutaneous tissue disorders | 2.7% 183 / 6,700 | 3.6% 9 / 251 | — | — | 2.4% 18 / 740 | 1.2% 4 / 326 | 8 |
| Pharyngitis Infections and infestations | 3.2% 154 / 4,857 | 0% 0 / 102 | 0.6% 1 / 159 | 0% 0 / 25 | — | — | 9 |
| Eczema Skin and subcutaneous tissue disorders | 2.8% 146 / 5,297 | 0.9% 3 / 331 | — | — | — | — | 6 |
| Arthralgia Musculoskeletal and connective tissue disorders | 3.1% 108 / 3,487 | 1.0% 1 / 105 | 9.5% 2 / 21 | — | — | — | 6 |
Side effects by organ system
Drug-arm event totals grouped by MedDRA System Organ Class. Top 5 specific terms shown per organ system.
The most common side effects with Bimekizumab primarily involve the body's immune response. Infections and infestations occurred in 4.3% of patients. Common infections included nasopharyngitis at 11.0%, oral candidiasis at 8.9%, and upper respiratory tract infection at 6.1%.
Other reported side effects were less frequent. Nervous system disorders were seen in 2.6% of patients, with headache being the most common at 4.0%. Skin and subcutaneous tissue disorders affected 1.5% of patients, including hidradenitis at 11.6%. Gastrointestinal disorders, musculoskeletal issues, and abnormal lab investigations each occurred in about 1% of patients.
Skin and subcutaneous tissue disorders
1.5%
847 of 54,743 on Bimekizumab
- Hidradenitis11.6%
- Psoriasis2.7%
- Eczema2.8%
- Dermatitis contact3.1%
- Seborrhoeic dermatitis1.6%
Gastrointestinal disorders
1.0%
466 of 45,794 on Bimekizumab
- Diarrhea3.4%
- Gastrooesophageal reflux disease1.5%
- Abdominal pain1.1%
- Dental caries1.0%
- Nausea0.8%
Musculoskeletal and connective tissue disorders
1.1%
347 of 31,623 on Bimekizumab
- Arthralgia3.1%
- Back pain2.1%
- Psoriatic arthropathy1.9%
- Osteoarthritis0.8%
- Tendonitis0.6%
Nervous system disorders
2.6%
306 of 11,910 on Bimekizumab
- Headache4.0%
- Paraesthesia0.2%
- Dysgeusia0.2%
- Tension headache2.0%
Investigations
1.0%
268 of 26,296 on Bimekizumab
- Gamma-glutamyltransferase increased1.5%
- Alanine aminotransferase increased1.6%
- Aspartate aminotransferase increased1.4%
- Blood pressure increased1.4%
- Hepatic enzyme increased1.0%
Vascular disorders
3.4%
193 of 5,607 on Bimekizumab
- Hypertension3.4%
Metabolism and nutrition disorders
1.0%
150 of 14,742 on Bimekizumab
- Hypercholesterolaemia1.4%
- Hyperlipidaemia1.0%
- Type 2 diabetes mellitus1.0%
- Diabetes mellitus0.8%
- Hyperuricaemia0.4%
Serious adverse events
Events classified as serious by the trial sponsor (events meeting ICH E2A criteria such as hospitalization, life-threatening, or death). Top 10 by drug-arm count.
| Adverse event | Bimekizumab | Placebo | Trials |
|---|---|---|---|
| Osteoarthritis Musculoskeletal and connective tissue disorders | 0.2% 18 / 7,216 | 0% 0 / 520 | 7 |
| Acute myocardial infarction Cardiac disorders | 0.2% 13 / 6,457 | 0% 0 / 311 | 6 |
| Myocardial infarction Cardiac disorders | 0.2% 12 / 7,574 | 0.3% 2 / 637 | 7 |
| Cellulitis Infections and infestations | 0.2% 12 / 6,553 | 0% 0 / 506 | 6 |
| Colitis ulcerative Gastrointestinal disorders | 0.1% 12 / 8,132 | 0% 0 / 340 | 7 |
| Pneumonia Infections and infestations | 0.2% 12 / 7,685 | 0% 0 / 664 | 8 |
| Syncope Nervous system disorders | 0.3% 11 / 4,227 | 0.4% 1 / 279 | 5 |
| Erysipelas Infections and infestations | 0.1% 11 / 7,411 | 0% 0 / 308 | 6 |
| Cholelithiasis Hepatobiliary disorders | 0.1% 11 / 7,461 | 0% 0 / 706 | 8 |
| Hidradenitis Skin and subcutaneous tissue disorders | 0.6% 11 / 1,818 | 0% 0 / 167 | 3 |
How Bimekizumab compares to other named comparators
Per-trial adverse-event rates from active-controlled trials. Each block reports top events from a single trial, so denominators reflect that trial only — no cross-trial pooling.
In head-to-head trials, Bimekizumab showed higher rates of oral candidiasis. Against certolizumab pegol, oral candidiasis occurred in 11.8% of Bimekizumab patients versus 0.0%. Pharyngitis was also higher for Bimekizumab at 9.8% versus 0.0% against certolizumab pegol. Against ustekinumab, oral candidiasis was 12.3% for Bimekizumab versus 0.3%. Diarrhea and nausea were 6.5% each for Bimekizumab versus 4.8% for adalimumab.
Comparators sometimes showed higher adverse event rates. Nasopharyngitis was 24.0% for certolizumab pegol versus 19.6% for Bimekizumab. It was 21.1% for secukinumab versus 12.0% for Bimekizumab. Against adalimumab, hidradenitis was 28.6% for adalimumab versus 17.4% for Bimekizumab. Fatigue rates were similar.
A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
| Adverse event | Bimekizumab | certolizumab pegol |
|---|---|---|
| Nasopharyngitis | 19.6% 10 / 51 | 24.0% 6 / 25 |
| Oral candidiasis | 11.8% 6 / 51 | 0% 0 / 25 |
| Pharyngitis | 9.8% 5 / 51 | 0% 0 / 25 |
| Ankylosing spondylitis | 7.8% 4 / 51 | 8.0% 2 / 25 |
| Influenza | 5.9% 3 / 51 | 0% 0 / 25 |
| Upper respiratory tract infection | 5.9% 3 / 51 | 4.0% 1 / 25 |
| Gamma-glutamyltransferase increased | 5.9% 3 / 51 | 4.0% 1 / 25 |
| Headache | 3.9% 2 / 51 | 8.0% 2 / 25 |
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
| Adverse event | Bimekizumab | adalimumab |
|---|---|---|
| Hidradenitis | 17.4% 8 / 46 | 28.6% 6 / 21 |
| Fatigue | 8.7% 4 / 46 | 9.5% 2 / 21 |
| Diarrhea | 6.5% 3 / 46 | 4.8% 1 / 21 |
| Nausea | 6.5% 3 / 46 | 4.8% 1 / 21 |
| Injection site reaction | 6.5% 3 / 46 | 0% 0 / 21 |
| Injection site pain | 6.5% 3 / 46 | 0% 0 / 21 |
| Oral candidiasis | 6.5% 3 / 46 | 4.8% 1 / 21 |
| Nasopharyngitis | 6.5% 3 / 46 | 4.8% 1 / 21 |
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
| Adverse event | Bimekizumab | ustekinumab |
|---|---|---|
| Nasopharyngitis | 16.2% 116 / 716 | 15.3% 50 / 326 |
| Oral candidiasis | 12.3% 88 / 716 | 0.3% 1 / 326 |
| Upper respiratory tract infection | 6.3% 45 / 716 | 7.1% 23 / 326 |
| Headache | 3.8% 27 / 716 | 5.2% 17 / 326 |
| Hypertension | 2.9% 21 / 716 | 4.6% 15 / 326 |
| Urinary tract infection | 2.5% 18 / 716 | 2.1% 7 / 326 |
| Back pain | 1.8% 13 / 716 | 4.0% 13 / 326 |
| Psoriasis | 1.7% 12 / 716 | 1.2% 4 / 326 |
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
| Adverse event | Bimekizumab | secukinumab |
|---|---|---|
| Nasopharyngitis | 12.0% 242 / 2,015 | 21.1% 156 / 740 |
| Oral candidiasis | 11.2% 226 / 2,015 | 2.0% 15 / 740 |
| Upper respiratory tract infection | 5.5% 110 / 2,015 | 7.2% 53 / 740 |
| Urinary tract infection | 4.1% 82 / 2,015 | 3.9% 29 / 740 |
| Psoriasis | 2.7% 55 / 2,015 | 2.4% 18 / 740 |
| Blood pressure increased | 1.4% 28 / 2,015 | 0.5% 4 / 740 |
| Intertrigo | 0.7% 15 / 2,015 | 0.7% 5 / 740 |
| Fall | 0.7% 14 / 2,015 | 0.3% 2 / 740 |
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
| Adverse event | Bimekizumab | adalimumab |
|---|---|---|
| Nasopharyngitis | 17.6% 166 / 941 | 23.9% 38 / 159 |
| Oral candidiasis | 12.4% 117 / 941 | 0% 0 / 159 |
| Upper respiratory tract infection | 6.6% 62 / 941 | 9.4% 15 / 159 |
| Hypertension | 4.0% 38 / 941 | 8.2% 13 / 159 |
| Pharyngitis | 3.5% 33 / 941 | 0.6% 1 / 159 |
| Diarrhea | 3.4% 32 / 941 | 2.5% 4 / 159 |
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
| Adverse event | Bimekizumab | adalimumab |
|---|---|---|
| Nasopharyngitis | 8.2% 92 / 1,116 | 4.7% 13 / 276 |
| Upper respiratory tract infection | 4.8% 54 / 1,116 | 2.9% 8 / 276 |
| Urinary tract infection | 3.9% 44 / 1,116 | 2.2% 6 / 276 |
| Oral candidiasis | 3.8% 42 / 1,116 | 0.4% 1 / 276 |
Cross-trial comparisons can be misleading because patient populations, dosing, and follow-up differ. Where head-to-head trials exist, those direct comparisons (BE VIVID, BE RADIANT, BE SURE for Bimekizumab) are the most defensible evidence base.
Side effects by indication
Different patient populations have different baseline event rates. Top adverse events grouped by indication.
Bimekizumab's side-effect profile shows some variation across different indications. Nasopharyngitis and upper respiratory tract infection are commonly reported across trials for plaque psoriasis, axial spondyloarthritis, and psoriatic arthritis. In plaque psoriasis trials, nasopharyngitis occurred in 13.5% and oral candidiasis in 10.9% of patients. For hidradenitis suppurativa, hidradenitis itself was a top adverse event, reported in 11.6% of patients, alongside oral candidiasis in 7.2% and headache in 5.6%. Headache also appeared in axial spondyloarthritis trials at 4.4%.
Plaque Psoriasis
12 trials · n=1,217 max cohort
- Nasopharyngitis13.5%
- Oral candidiasis10.9%
- Upper respiratory tract infection6.8%
- Urinary tract infection4.0%
- Hypertension3.6%
Axial Spondyloarthritis
5 trials · n=330 max cohort
- Nasopharyngitis9.6%
- Upper respiratory tract infection6.7%
- Headache4.4%
- Oral candidiasis5.6%
- Diarrhea3.6%
Psoriatic Arthritis
4 trials · n=431 max cohort
- Nasopharyngitis8.1%
- Upper respiratory tract infection5.6%
- Oral candidiasis4.0%
- Urinary tract infection3.5%
- Bronchitis4.9%
Hidradenitis Suppurativa
3 trials · n=290 max cohort
- Hidradenitis11.6%
- Oral candidiasis7.2%
- Headache5.6%
- Diarrhea5.2%
- Nasopharyngitis4.8%
Trial discontinuations due to adverse events
Per-arm participant counts that exited a trial citing “adverse event” as the reason, sourced from the AACT drop_withdrawals table.
| NCT ID | Arm | Withdrew (AE) |
|---|---|---|
| NCT03598790 | Cohort A: BKZ 320 mg Q4W/Q8W | 33 |
| NCT03598790 | Cohort A: BKZ 320 mg Q8W | 24 |
| NCT03598790 | Cohort A: BKZ 320 mg Q4W | 24 |
| NCT03355573 | Bimekizumab | 17 |
| NCT03536884 | OLE Period: Secukinumab Week 0-48/ BKZ Q4W 320 mg | 13 |
| NCT03370133 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W | 12 |
| NCT03536884 | OLE Period: BKZ Week 0-48/BKZ Q8W 320 mg | 10 |
| NCT04242446 | Placebo/BKZ Dosing Regimen 2 | 9 |
| NCT04242498 | BKZ Dosing Regimen 2 | 9 |
| NCT03347110 | Bimekizumab 160 mg | 9 |
| NCT03895203 | BKZ 160 mg Q4W/BKZ 160 mg Q4W | 9 |
| NCT03928743 | Bimekizumab 160 mg Q4W (Week 16 up to Week 52) | 9 |
| NCT03536884 | ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W | 8 |
| NCT03536884 | OLE Period: BKZ Week 0-48/ BKZ Q4W 320 mg | 8 |
| NCT03895203 | BKZ 160 mg Q4W | 8 |
| NCT04242446 | BKZ Dosing Regimen 2 | 7 |
| NCT04242446 | BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 | 7 |
| NCT04242498 | BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 | 7 |
| NCT02963506 | BKZ 320 mg - BKZ 320 mg | 6 |
| NCT04242446 | BKZ Dosing Regimen 2/BKZ Dosing Regimen 2 | 6 |
| NCT03412747 | Adalimumab | 6 |
| NCT04242498 | BKZ Dosing Regimen 2/BKZ Dosing Regimen 1 | 6 |
| NCT03536884 | ITP: Secukinumab 300 mg Q4W | 6 |
| NCT03536884 | OLE Period: Secukinumab Week 0-48/ BKZ Q8W 320 mg | 6 |
| NCT06011733 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | 6 |
Sources and methodology
Data is pulled from the AACT (Aggregate Analysis of ClinicalTrials.gov) database. Adverse-event counts come from each trial’s reported_events table; arms are classified as Bimekizumab, placebo, or named active comparator using the AACT result_groups.title field. Rates are subjects_affected / subjects_at_risk × 100, summed across trials at the term level when multiple trials reported the same MedDRA term.
Trials sourced (24):
| NCT ID | Title | Phase | Enrollment | AE terms |
|---|---|---|---|---|
| NCT03598790 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | PHASE3 | 1,353 | 302 |
| NCT03895203 | A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | PHASE3 | 852 | 72 |
| NCT03536884 | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | PHASE3 | 743 | 134 |
| NCT03370133 | A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | PHASE3 | 567 | 52 |
| NCT04242498 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | 509 | 34 |
| NCT04242446 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | 505 | 52 |
| NCT03412747 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | PHASE3 | 478 | 36 |
| NCT03410992 | A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | PHASE3 | 435 | 37 |
| NCT03896581 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis | PHASE3 | 400 | 11 |
| NCT03928743 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis | PHASE3 | 332 | 26 |
| NCT02963506 | A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis | PHASE2 | 303 | 27 |
| NCT03928704 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis | PHASE3 | 274 | 46 |
| NCT03355573 | A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis | PHASE2 | 255 | 61 |
| NCT02905006 | Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis | PHASE2 | 250 | 17 |
| NCT03010527 | A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis | PHASE2 | 217 | 46 |
| NCT02969525 | A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis | PHASE2 | 206 | 19 |
| NCT03347110 | A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis | PHASE2 | 184 | 24 |
| NCT03766685 | A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) | PHASE3 | 172 | 2 |
| NCT06011733 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | 133 | 20 |
| NCT03248531 | A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. | PHASE2 | 90 | 21 |
| NCT03215277 | A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis | PHASE2 | 76 | 26 |
| NCT03025542 | A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis | PHASE2 | 49 | 46 |
| NCT05020249 | A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis | PHASE3 | 47 | 11 |
| NCT03230292 | A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis | PHASE2 | 43 | 11 |
Looking for more on Bimekizumab? See trials, dosing, conditions, and recruiting locations on the Bimekizumab overview page.
Compare Bimekizumab alternatives →Informational only. This page is a structured summary of clinical trial registry data and does not constitute medical advice. Talk to your prescriber about side-effect risk in your individual case. Adverse-event rates from trials may not match real-world post-marketing experience. For prescribing information, consult the FDA-approved drug label.
Data sourced from the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI). Side-effects aggregate generated .