ITVISMA safety profile
The safety profile of ITVISMA was studied in treatment-naive and previously treated patient groups1
The safety profile of ITVISMA was studied in 153 patients from 2 clinical studies. Patients who received a single intrathecal injection of ITVISMA and patients who underwent a sham procedure were followed for a duration of 52 weeks in both studies.1
Adverse reactions occurring in ≥2% of patients or with higher frequency in patients treated with ITVISMA compared to sham group (STEER study)1 | ||
| Adverse reactions | ITVISMA (n=75), n (%) | Sham-controlled (n=51), n (%) |
| Upper respiratory tract infectiona | 31 (41%) | 15 (29%) |
| Pyrexia | 19 (25%) | 12 (24%) |
| Upper gastrointestinal symptomsa | 20 (27%) | 8 (16%) |
| Hepatic enzyme increaseda | 6 (8%)b | 5 (10%) |
| Headache | 8 (11%) | 2 (4%) |
| Dizziness | 4 (5%) | 1 (2%) |
| Pain in extremity | 3 (4%) | 1 (2%) |
| Thrombocytopeniaa | 3 (4%) | 0 |
| Sensory disturbancea | 2 (3%)c | 1 (2%)d |
aIs a composite term that includes multiple related terms.1
bTwo patients had alanine aminotransferase (ALT) elevations of 20 times the upper limit of normal (ULN).1
cSigns and symptoms that may be suggestive of dorsal root ganglion (DRG) toxicity occurred within 34 weeks of ITVISMA injection and stabilized but remained unresolved at the end of study period.1
dOccurred 154 days after the sham procedure and resolved after 15 days without intervention.1
Safety evaluated in the STRENGTH study of patients with spinal muscular atrophy (SMA) who were previously treated with nusinersen or risdiplam did not identify any additional safety events with ITVISMA administration compared to the STEER study.1
Selected adverse events
Peripheral sensory neuropathy
Peripheral sensory neuropathy has occurred with ITVISMA administration.1
Signs and symptoms may include numbness, tingling, prickling, or pain in the arms, hands, legs, and/or feet, with onset seen at approximately 3 weeks post-injection in clinical studies.1
Consider complete neurologic evaluation and other testing and/or symptom management based on the patient’s clinical presentation. Inform patients and caregivers about the signs and symptoms of peripheral sensory neuropathy, and that peripheral sensory neuropathy has occurred with ITVISMA administration. Advise patients and caregivers to contact their health care provider promptly if the patient experiences numbness, tingling, prickling, or pain in the arms, hands, legs and/or feet.1