Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Adverse reactions through Week 16 of the placebo-controlled trials (Pool S1) by sex, age, and race are presented in Table 8, Table 9, and Table 10.
Table 8. Adverse Reactions Occurring in ≥1% of Subjects Treated With BIMZELX and More Frequently in BIMZELX Than Placebo, by Sex, Pool S1
|
Adverse Reaction |
BIMZELX |
Placebo |
||
|---|---|---|---|---|
|
Female |
Male |
Female |
Male |
|
| Upper respiratory infectionsa |
37 (19.9) |
65 (13.4) |
9 (17.6) |
15 (12.7) |
| Candida infectionsb |
23 (12.4) |
43 (8.9) |
1 (2.0) |
0 (0.0) |
| Headache |
8 (4.3) |
14 (2.9) |
0 (0.0) |
0 (0.0) |
| Injection site reactionsc |
8 (4.3) |
11 (2.3) |
1 (2.0) |
1 (0.8) |
| Tinea infectionsd |
1 (0.5) |
17 (3.5) |
0 (0.0) |
1 (0.8) |
| Gastroenteritise |
9 (4.8) |
20 (4.1) |
3 (5.9) |
3 (2.5) |
| Herpes simplex infectionsf |
5 (2.7) |
4 (0.8) |
0 (0.0) |
0 (0.0) |
| Acne |
4 (2.2) |
4 (0.8) |
0 (0.0) |
0 (0.0) |
| Folliculitis |
1 (0.5) |
7 (1.4) |
0 (0.0) |
0 (0.0) |
| Fatigue |
2 (1.1) |
5 (1.0) |
0 (0.0) |
0 (0.0) |
Source: Adapted from FDA Review
a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza
b Candida infections include oral candidiasis, oropharyngeal candidiasis, vulvovaginal candidiasis, vulvovaginal mycotic infection, oral fungal infection, oropharyngitis fungal, skin candida, genital candidiasis, and fungal pharyngitis
c Injection site reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling
d Tinea infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis
e Gastroenteritis includes gastroenteritis, gastroenteritis viral, gastroenteritis bacterial, enterovirus infection, diarrhea, nausea, vomiting, enteritis, enterocolitis, and gastritis
f Herpes simplex infections include herpes simplex and oral herpes
Table 9. Adverse Reactions Occurring in ≥1% of Subjects Treated With BIMZELX and More Frequently in BIMZELX Than Placebo, by Age Group, Pool S1
|
Adverse Reaction |
BIMZELX |
Placebo |
||||
|---|---|---|---|---|---|---|
|
<40 Years |
40 to <65 Years |
≥65 Years |
<40 Years |
40 to <65 Years |
≥65 Years |
|
| Upper respiratory infectionsa |
50 (20.1) |
47 (12.8) |
5 (9.1) |
13 (24.1) |
10 (9.9) |
1 (7.1) |
| Candida infectionsb |
24 (9.6) |
32 (8.7) |
10 (18.2) |
0 (0.0) |
1 (1.0) |
0 (0.0) |
| Headache |
12 (4.8) |
9 (2.5) |
1 (1.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Injection site reactionsc |
9 (3.6) |
8 (2.2) |
2 (3.6) |
2 (3.7) |
0 (0.0) |
0 (0.0) |
| Tinea infectionsd |
8 (3.2) |
9 (2.5) |
1 (1.8) |
0 (0.0) |
1 (1.0) |
0 (0.0) |
| Gastroenteritise |
14 (5.6) |
13 (3.6) |
2 (3.6) |
3 (5.6) |
2 (2.0) |
1 (7.1) |
| Herpes simplex infectionsf |
7 (2.8) |
1 (0.3) |
1 (1.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Acne |
4 (1.6) |
4 (1.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Folliculitis |
4 (1.6) |
4 (1.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Fatigue |
4 (1.6) |
2 (0.5) |
1 (1.8) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Source: Adapted from FDA Review
a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza
b Candida infections include oral candidiasis, oropharyngeal candidiasis, vulvovaginal candidiasis, vulvovaginal mycotic infection, oral fungal infection, oropharyngitis fungal, skin candida, genital candidiasis, and fungal pharyngitis
c Injection site reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling
d Tinea infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis
e Gastroenteritis includes gastroenteritis, gastroenteritis viral, gastroenteritis bacterial, enterovirus infection, diarrhea, nausea, vomiting, enteritis, enterocolitis, and gastritis
f Herpes simplex infections include herpes simplex and oral herpes
Table 10. Adverse Reactions Occurring in ≥1% of Subjects Treated With BIMZELX and More Frequently in BIMZELX Than Placebo, by Race, Pool S1
|
Adverse Reaction |
BIMZELX |
Placebo |
|||||
|---|---|---|---|---|---|---|---|
|
Asian |
Black or |
Other |
White |
Asian |
Other |
White |
|
| Upper respiratory infectionsa |
14 (16.7) |
1 (6.7) |
3 (30.0) |
84 (15.0) |
2 (8.0) |
1 (50.0) |
21 (14.8) |
| Candida infectionsb |
7 (8.3) |
1 (6.7) |
0 (0.0) |
58 (10.3) |
0 (0.0) |
0 (0.0) |
1 (0.7) |
| Headache |
1 (1.2) |
0 (0.0) |
0 (0.0) |
21 (3.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Injection site reactionsc |
3 (3.6) |
0 (0.0) |
0 (0.0) |
16 (2.9) |
1 (4.0) |
0 (0.0) |
1 (0.7) |
| Tinea infectionsd |
5 (6.0) |
0 (0.0) |
0 (0.0) |
13 (2.3) |
0 (0.0) |
0 (0.0) |
1 (0.7) |
| Gastroenteritise |
7 (8.3) |
1 (6.7) |
0 (0.0) |
21 (3.7) |
2 (8.0) |
0 (0.0) |
4 (2.8) |
| Herpes simplex infectionsf |
0 (0.0) |
0 (0.0) |
0 (0.0) |
9 (1.6) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Acne |
4 (4.8) |
0 (0.0) |
0 (0.0) |
4 (0.7) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Folliculitis |
2 (2.4) |
0 (0.0) |
0 (0.0) |
6 (1.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
| Fatigue |
0 (0.0) |
1 (6.7) |
0 (0.0) |
6 (1.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Source: Adapted from FDA Review
a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza
b Candida infections include oral candidiasis, oropharyngeal candidiasis, vulvovaginal candidiasis, vulvovaginal mycotic infection, oral fungal infection, oropharyngitis fungal, skin candida, genital candidiasis, and fungal pharyngitis
c Injection site reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling
d Tinea infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis
e Gastroenteritis includes gastroenteritis, gastroenteritis viral, gastroenteritis bacterial, enterovirus infection, diarrhea, nausea, vomiting, enteritis, enterocolitis, and gastritis
f Herpes simplex infections include herpes simplex and oral herpes
