ADVERSE EVENTS
PROFILE: AGES 2-11
WELL-STUDIED SAFETY PROFILE IN PATIENTS 2-111-5
ADVERSE REACTIONS THROUGH 8 WEEKS IN THE TRuE-AD3 PHASE 3 STUDY1*
| Common ARs occurring in ≥1% patients receiving OPZELURA | OPZELURA n = 130 n (%) | Vehicle n = 65 n (%) |
|---|---|---|
| Upper respiratory tract infection† | 20 (15) | 7 (11) |
| COVID-19 | 6 (5) | 2 (3) |
| Application site reaction‡ | 6 (5) | 1 (2) |
| Pyrexia | 3 (2) | 0 (0) |
| White blood cell decreased§ | 2 (2) | 0 (0) |
*Subjects with cytopenias (defined as hemoglobin <10 g/dL, absolute neutrophil count (ANC) <1000/μL, and platelet count <100,000/μL) at screening were excluded from the trial. The impact of OPZELURA on blood cell counts in this population has not been studied.1
†Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, rhinorrhea, oropharyngeal pain, respiratory tract congestion, viral upper respiratory tract infection.1
‡Application site reaction includes application site pain, application site irritation, application site discomfort, application site pruritus.1
§White blood cell decreased includes white blood cell decreased, leukopenia.1
AR, adverse reaction; COVID-19, coronavirus disease 2019.
Low rate of discontinuation
due to TEAEs:
0.8% with OPZELURA vs. 0% with vehicle5
Well-studied safety and tolerability through 52 weeks2
| Common TEAEs occurring in ≥3% of patients receiving OPZELURA | OPZELURA n = 159 n (%) |
|---|---|
| Upper respiratory tract infection | 23 (14.9) |
| Nasopharyngitis | 20 (13.0) |
| COVID-19 | 11 (7.1) |
| Gastroenteritis viral | 7 (4.5) |
| Otitis media | 7 (4.5) |
| Diarrhea | 6 (3.9) |
| Ear infection | 6 (3.9) |
| Pyrexia | 6 (3.9) |
| Vomiting | 6 (3.9) |
OPZELURA is for topical short-term and non-continuous use only1
Adverse events through 52 weeks inclusive of 8-week vehicle control and long-term extension periods4
- Safety data from the 44-week extension study are not included in the Prescribing Information for OPZELURA
- No conclusions of safety should be made based on these results
- Adverse reaction rates observed in clinical trials and long-term extension studies may not predict the rates observed in a broader patient population in clinical practice
COVID-19, coronavirus disease 2019; TEAE, treatment-emergent adverse event.
SAFETY CONSIDERATIONS2,6
Exposure-adjusted incidence rates of select TEAEs from baseline to Week 522,6*
| SELECT TEAEs | OPZELURA E/100 PY (n = 154) PY = 112.88 |
|---|---|
| Serious infections | 0.9 |
| Opportunistic infections | 0 |
| Tuberculosis | 0 |
| Herpes zoster | 0 |
| NMSC | 0 |
| Other malignancies (excluding NMSC) | 0 |
| Major adverse cardiovascular events | 0 |
| Thromboembolic events | 0 |
| Mortality | 0 |
Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in a broader patient population in clinical practice.
Exposure-adjusted incidence rates are presented to support evaluation of safety; however, they do not account for the timing or recurrence of adverse events and may underestimate risk in the presence of time-varying hazards or differential exposure durations.
*Not inclusive of adverse event information collected in earlier phase trials or trials involving other disease states.
E/100 PY, exposure-adjusted incidence rate (the number of patients with the event per 100 patient years of exposure); LTE, long-term extension;
NMSC, non-melanoma skin cancer; PY, patient years of exposure (defined as the duration from first cream application to last application);
TEAE, treatment-emergent adverse event.
