Favorable safety profile in two clinical trials
SPEVIGO® was generally well tolerated1
EFFISAYIL® 1: Selected adverse reactions occurring in ≥1% of the SPEVIGO® IV group and more frequently than in the placebo group through Week 11
| SPEVIGO® (n=35) | Placebo (n=18) | |
|---|---|---|
| General disorders and administration site conditions | ||
| Asthenia and fatigue | 9% | 6% |
| Headache | 9% | 6% |
| Pruritus and prurigo | 6% | 0% |
| Infusion site hematoma and bruising | 6% | 0% |
| Urinary tract infection | 6% | 0% |
| Bacteremia | 3% | 0% |
| Bacteriuria | 3% | 0% |
| Cellulitis | 3% | 0% |
| Herpes dermatitis and oral herpes | 3% | 0% |
| Upper respiratory infection | 3% | 0% |
| Dyspnea | 3% | 0% |
| Eye edema | 3% | 0% |
| Urticaria | 3% | 0% |
Adapted from the Product Monograph.
EFFISAYIL® 2: Adverse reactions occurring in ≥3% of the SPEVIGO® SC group and more frequently than the placebo group through Week 48
| SPEVIGO® (n=93)* | Placebo (n=30) | |
|---|---|---|
| Injection site reactions† | 18% | 7% |
| Urinary tract infections | 5% | 0% |
| Pruritus | 4% | 0% |
Adapted from the Product Monograph.
In both EFFISAYIL® 2 and EFFISAYIL® 1, the most frequent adverse reactions associated with SPEVIGO® were infections1
- During the 1-week, placebo-controlled period in EFFISAYIL® 1, infections were reported in 17.1% (n=6) of SPEVIGO® patients vs. 5.6% (n=1) with placebo
- Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection
- In EFFISAYIL® 1, serious infection was reported in 1 patient (2.9%) in the SPEVIGO® group and no patients in the placebo group
- During the placebo-controlled period of up to 48 weeks in EFFISAYIL® 2, infections were reported in 33.3% of patients treated with SPEVIGO® vs. 33.3% with placebo
- In EFFISAYIL® 2, serious infections were reported in 3 patients (3.2%) in the SPEVIGO® group and no patients in the placebo group
In EFFISAYIL® 1, local tolerability was assessed after Day 1 and Day 8 infusions based on six symptoms and 3 grades of intensity1‡
- On Day 1, 17.1% (n=6) of SPEVIGO® patients had mild to moderate symptoms. In the placebo group, 5.6% (n=1) had symptoms (heat of moderate intensity) on Day 1
- On Day 8, no patients had symptoms
- No severe symptoms were reported in any treatment group
The available data with SPEVIGO® in pediatric subjects are limited. No new safety concerns were identified based on the limited number of treated adolescent subjects.
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*
The SPEVIGO® group includes patients who received any of the three doses of SPEVIGO® in the EFFISAYIL® 2 trial.
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†
Includes erythema, pain, swelling, induration, urticaria, and warmth at the injection site. Injection site reactions observed in EFFISAYIL® 2 were typically mild to moderate in severity.
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‡
The symptoms assessed included swelling, induration, heat, redness, pain and other; intensity was mild, moderate and severe.
