SPEVIGO® was generally well tolerated1
Selected adverse reactions occurring in ≥1% of the SPEVIGO® 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% |
| Pruritis 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.
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) placebo1
- Infections observed in clinical trials with spesolimab were generally mild to moderate with no distinct pattern regarding pathogen or type of infection1
- Serious infection was reported in 1 patient (2.9%) 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 intensity*
- 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 group1
