Established safety
and tolerability1
Consistent safety results in clinical trials1
Trial 3 evaluated long-term safety1
Infusion-associated reactions were experienced
in clinical trials1
ADAs were associated with lower plasma
concentrations of Lamzede1
The most common adverse events in Trial 1 were1:
| Adverse Event | N=15 |
|---|---|
| Nasopharyngitis | 10 (66%) |
| Pyrexia | 6 (40%) |
| Headache | 5 (33%) |
| Arthralgia | 3 (20%) |
| Acute tonsillitis, urinary tract infection, eye pruritus, gastroenteritis, hypersensitivity, influenza, syncope, toothache, back pain, and ear infection |
2 (13%) each |
In the event of a severe hypersensitivity reaction (including anaphylaxis) or severe infusion-associated reaction, immediately discontinue Lamzede administration and initiate appropriate medical treatment.1
In Trial 2, 5 pediatric patients (aged 3 to 5 years old) received Lamzede
weekly for a mean exposure of 121 weeks1:
- One patient treated with Lamzede presented serious reactions (chills and hyperthermia on the same occasion)
- Additional adverse reactions that occurred in at least 2 of 5 patients included: cough, otitis media, rhinitis, conjunctivitis, fall, ligament sprain, oropharyngeal pain, swelling face, and upper respiratory tract infection
Selected safety topics
In Trial 3, 33 patients (aged 6 to 35 years old) received Lamzede weekly for a mean exposure of 625 days in adult patients and 1,086 days in pediatric patients1
- In Trial 3, 1 patient was withdrawn due to repeated IARs and successfully reintroduced to treatment after 89 weeks
- Adverse events (≥10%) included abdominal pain upper, contusion, excoriation, post-lumbar puncture syndrome, wound, weight increased, erythema, rash, and tooth extraction
Infusion-associated reactions were reported in 19 (50%) patients in clinical trials1
- Options for managing mild to moderate IARs include pausing the infusion for 15 to 30 minutes and slowing the infusion to 25% to 50% of the recommended rate
- If symptoms subside after pausing or slowing the infusion, resume at 25% to 50% of the recommended rate and increase by increments of 25% until the recommended rate is reached
In clinical trials, development of ADAs was associated with lower plasma concentrations of Lamzede1
The observed incidence of ADAs is highly dependent on the sensitivity and specificity of the assay.
- In Trial 2, 4 out of 5 pediatric patients (80%) developed ADAs, while 3 out of 4 ADA-positive patients (75%) developed neutralizing antibodies
- In Trial 3, 5 patients (1 adult and 4 pediatric) (15%) had pre-existing ADAs and for 1 patient the ADA level increased after treatment with Lamzede. Four other patients (1 adult and 3 pediatric) (12%) developed ADAs after treatment with Lamzede
- In Trial 1, 4 patients with ADA-positive results also had neutralizing antibodies. However, NAb-positive results of similar magnitude were detected in 4 patients during treatment with placebo
ADAs, anti-drug antibodies; IAR, infusion-associated reaction; NAb, neutralizing antibody.