Summary of the safety profile The most common adverse reactions are lymphopenia (11%) and headache (7%). Tabulated list of adverse reactions The adverse reactions observed in patients treated with etrasimod are listed below by system organ class (SOC) and frequency category.
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000).
Table 1:
Adverse reactions System organ class (SOC) Very common Common Uncommon Infections and infestations Urinary tract infectiona, lower respiratory tract infectionb Blood and lymphatic system disorders Lymphopeniac Neutropenia 11 Metabolism and nutrition disorders Hypercholesterolaemiad Nervous system disorders Headache, dizziness Eye disorders Visual impairment Macular oedema Cardiac disorders Bradycardiae Atrioventricular blockf Vascular disorders Hypertension Hepatobiliary disorders Hepatic enzyme increased a Urinary tract infection includes urinary tract infection and cystitis.
b Lower respiratory tract infection includes bronchitis and pneumonia. c Lymphopenia includes lymphopenia, lymphocyte count decreased, and lymphocyte percentage decreased. d Hypercholesterolaemia includes hypercholesterolaemia and blood cholesterol increased.
e Bradycardia includes bradycardia and sinus bradycardia. See “Description of selected adverse reactions” below. f Atrioventricular block includes first- or second-degree Mobitz type I. See “Description of selected adverse reactions” below.
5% of patients treated with etrasimod. 4% of patients treated with etrasimod. 1). 6% of patients treated with etrasimod. Events of AV block were mostly transient and asymptomatic. 1). 9%, respectively). Etrasimod increased the risk of urinary tract infections and lower respiratory tract infections (see Table 1).
1). 5% in ELEVATE UC 52 and ELEVATE UC 12. These events did not lead to treatment discontinuation. 2% in ELEVATE UC 52 and ELEVATE UC 12. These events did not lead to treatment discontinuation. 0% of patients treated with etrasimod, respectively.
The majority (75%) of patients with ALT greater than 3-fold the ULN continued treatment with etrasimod with values returning to less than 3-fold the ULN while on treatment. 4% in patients treated with etrasimod. 12 Hepatic enzyme increased includes events of gamma glutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hepatic function abnormal, liver disorder, liver function test abnormal, and transaminases increased (see Table 1).
Increased blood pressure In ELEVATE UC 52 and ELEVATE UC 12, patients treated with etrasimod had an average increase of approximately 1 to 4 mm Hg in systolic blood pressure and approximately 1 to 2 mm Hg in diastolic blood pressure.
The increase was first detected after 2 weeks of treatment and remained within the specified average range in blood pressure increases throughout treatment. 1% of patients treated with etrasimod. All the events were mild to moderate in severity.
4% of patients treated with etrasimod. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.