ADVERSE EVENTS PROFILE: AGES 12+
WELL-STUDIED SAFETY PROFILE IN PATIENTS 12+1-4
ADVERSE REACTIONS REPORTED IN PHASE 3 TRIALS OF OPZELURA
ADVERSE REACTIONS OCCURRING IN ≥1% OF SUBJECTS TREATED WITH OPZELURA FOR ATOPIC DERMATITIS THROUGH WEEK 81,2
| Adverse Reaction | OPZELURA n = 499 n (%) | Vehicle n = 250 n (%) |
|---|---|---|
| Subjects with any TEAE | 132 (27) | 83 (33) |
| Nasopharyngitis | 13 (3) | 2 (1) |
| Bronchitis | 4 (1) | 0 (0) |
| Ear infection | 4 (1) | 0 (0) |
| Eosinophil count increased | 4 (1) | 0 (0) |
| Urticaria | 4 (1) | 0 (0) |
| Diarrhea | 3 (1) | 1 (<1) |
| Folliculitis | 3 (1) | 0 (0) |
| Tonsillitis | 3 (1) | 0 (0) |
| Rhinorrhea | 3 (1) | 1 (<1) |
Low rate of treatment-related application site reactions such as burning (0.8% with OPZELURA vs. 4.4% with vehicle) and pruritus (0% with OPZELURA vs. 2.4% with vehicle)2
Low rate of discontinuation due to TEAEs: 0.8% with OPZELURA vs. 3.2% with vehicle2
Adverse reactions occurring in <1% for OPZELURA vs. 0% for vehicle were neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, staphylococcal infection, and acneiform dermatitis1
No atrophy or striae were reported in either OPZELURA or vehicle groups4
TEAE, treatment-emergent adverse event.
TEAEs THROUGH 52-WEEK STUDY PERIOD
COMMON TEAEs OCCURRING IN ≥2% OF PATIENTS RECEIVING OPZELURA IN THE 52-WEEK STUDY PERIOD3
| TEAE | OPZELURA n = 598* n (%) |
|---|---|
| Upper respiratory tract infection | 60 (10.0) |
| Nasopharyngitis | 58 (9.7) |
| Headache | 24 (4.0) |
| Bronchitis | 20 (3.3) |
| Influenza | 18 (3.0) |
| Rhinitis | 12 (2.0) |
| Atopic dermatitis | 12 (2.0) |
| Asthma | 12 (2.0) |
OPZELURA is for short-term and non-continuous use only1
Adverse events through 52 weeks inclusive of 8-week vehicle control and long-term extension periods3
- 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
*Includes patients who received ≥1 dose of OPZELURA in the vehicle-controlled and/or extension periods.3
TEAE, treatment-emergent adverse event.
SAFETY CONSIDERATIONS1,4
Exposure-adjusted incidence rates of select TEAEs from baseline to Week 521,4*
| OPZELURA E/100 PY (n = 598) PY = 466.00 | Vehicle E/100 PY (n = 250) PY = 34.99 | |
|---|---|---|
| Serious infections | 0.2 | 0.0 |
| Opportunistic infections | 0.0 | 0.0 |
| Tuberculosis | 0.0 | 0.0 |
| Herpes zoster | 1.1 | 0.0 |
| Mortality | 0.0 | 0.0 |
| Malignancies and lymphoproliferative disorders | ||
| Lymphomas | 0.0 | 0.0 |
| NMSC | 0.4 | 0.0 |
| Other malignancies (excluding lymphomas and NMSC) | 0.0 | 2.9 |
| Major adverse cardiovascular events (MACE) | ||
| Cardiovascular death | 0.0 | 0.0 |
| Myocardial infarction | 0.0 | 0.0 |
| Cerebrovascular accident (nonfatal stroke) | 0.2 | 0.0 |
| Venous thromboembolic events | ||
| Pulmonary embolism | 0.2 | 0.0 |
| Deep venous thrombosis | 0.2 | 0.0 |
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.
