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SAFETY

OPZELURA WAS GENERALLY WELL TOLERATED IN CLINICAL TRIALS34

See Prescribing Information for full details

AEs in TRuE - V1Week 24*Week 52†
Parameter, n(%)Vehicle (n=109)Opzelura (n=221)Vehicle to Opzelura (n=90)Opzelura (n=193)
Any AE42 (38.5)101 (45.7)31 (34.4)65 (33.7)
Most common AEs‡    
COVID - 19§5 (4.6)3 (1.4)1 (1.1)11 (5.7)
Application-site acne013 (5.9)01 (0.5)
Nasopharyngitis4 (3.7)9 (4.1)2 (2.2)3 (1.6)
Headache2 (1.8)9 (4.1)2 (2.2)3 (1.6)
Application-site pruritus4 (3.7)11 (5.0)1 (1.1)1 (0.5)
Upper respiratory tract infection5 (4.6)6 (2.7)3 (3.3)2 (1.0)
Sinusitis3 (2.8)4 (1.8)1 (1.1)3 (1.6)
Application-site dermatitis03 (1.4)01 (0.5)
Application-site rash1 (0.9)5 (2.3)1 (1.1)1 (0.5)
Oral herpes2 (1.8)2 (0.9)2 (2.2)2 (1.0)
Urinary tract infection1 (0.9)5 (2.3)01 (0.5)
Acne1 (0.9)2 (0.9)3 (3.3)0
Pyrexia01 (0.5)00
Application-site exfoliation0000
Hypothyroidism002 (2.2)1 (0.5)
AE related to trial agent10 (9.2)38 (17.2)5 (5.6)7 (3.6)
Most common AE related to trial agent    

Application-site acne

012 (5.4)01 (0.5)
Application-site pruritus4 (3.7)11 (5.0)1 (1.1)0
Application-site exfoliation0000

Serious AE**,††

1 (0.9)6 (2.7)1 (1.1)1 (0.5)

AE leading to discontinuation of trial agent

1 (0.9)1 (0.5)00

OPZELURA WAS WELL TOLERATED

WITH LOW RATES OF APPLICATION SITE RASHES (<2.5%) AND TREATMENT-RELATED DISCONTINUATIONS (<10%)

  • text Safety data in TRuE-V2 were similar to TRuE-V134
  • text Laboratory monitoring is not needed due to the limited systemic exposure1
    • Opzelura is contraindicated during pregnancy1

* AEs during the double-blind period (up to Week 24) are reported in the safety population (Opzelura group and vehicle group).

† AEs during the open-label treatment extension period (after Week 24) are reported in the treatment-extension evaluable population (Opzelura group and vehicle-to-Opzelura group).

‡ Shown are events that occurred in more than 2% of the patients in any group.

§ On the basis of the prevalence of COVID-19 at the time the trials were conducted, the incidence of COVID-19 was not considered to be relevant to Opzelura application.

¶ The relatedness of the AE to Opzelura was determined by the investigator.

** No serious AEs were considered by investigators to be related to Opzelura according to criteria prespecified in the protocol.

†† In TRuE-V1, serious AEs with application of Opzelura were anal fistula, appendicitis, concussion, hepatitis due to infectious mononucleosis, hypersensitivity, kidney contusion, myocarditis, prostate cancer, and subacute combined

cord degeneration (in one patient each); hypersensitivity and subacute combined cord degeneration occurred in the same patient. In TRuE-V2, serious AEs with Opzelura were appendiceal abscess, coronary-artery stenosis, joint

dislocation, papillary thyroid cancer, rhabdomyolysis, and ureterolithiasis (in one patient each).

AE, adverse event; COVID-19, coronavirus disease 2019.

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