This website is for UK Healthcare Professionals only

MONITORING IN ROUTINE PATIENT MANAGEMENT1

Table adapted from RINVOQ Summary of Product Characteristics.1

*For lipids, evaluate 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia.1

Treatment with RINVOQ should be interrupted if patients develop serious or opportunistic infection, elevations in hepatic transaminases, or any changes in the CBC, such as low haemoglobin, lymphocyte or neutrophil count.

ALC, absolute lymphocyte count; ALT, alanine transanimase; ANC, absolute neutrophil count; AST, aspartate transanimase; CBC, complete blood count; DVT, deep vein thrombosis; Hb, haemoglobin; PE, pulmonary embolism; TB, tuberculosis.

Infections1
In the placebo-controlled period of the clinical studies, the frequency of infection over 16 weeks in the upadacitinib 15 mg and 30 mg groups was 39% and 43% compared to 30% in the placebo group, respectively. The long-term rate of infections for the upadacitinib 15 mg and 30 mg groups was 98.5 and 109.6 events per 100 patient-years, respectively.

In placebo-controlled clinical studies, the frequency of serious infection over 16 weeks in the upadacitinib 15 mg and 30 mg groups was 0.8% and 0.4% compared to 0.6% in the placebo group, respectively. The long-term rate of serious infections for the upadacitinib 15 mg and 30 mg groups was 2.3 and 2.8 events per 100 patient-years, respectively.

Opportunistic infections (excluding tuberculosis)1
In the placebo-controlled period of the clinical studies, all opportunistic infections (excluding TB and herpes zoster) reported were eczema herpeticum. The frequency of eczema herpeticum over 16 weeks in the upadacitinib 15 mg and 30 mg groups was 0.7% and 0.8% compared to 0.4% in the placebo group, respectively. The long-term rate of eczema herpeticum for the upadacitinib 15 mg and 30 mg groups was 1.6 and 1.8 events per 100 patient-years, respectively. One case of esophageal candidiasis was reported with upadacitinib 30 mg.

The long-term rate of herpes zoster for the upadacitinib 15 mg and 30 mg groups was 3.5 and 5.2 events per 100 patient-years, respectively. Most of the herpes zoster events involved a single dermatome and were non-serious.

Laboratory abnormalities1
Dose-dependent changes in ALT increased and/or AST increased (≥ 3 x ULN), lipid parameters, CPK values (> 5 x ULN), and neutropenia (ANC < 1 x 109 cells/L) associated with upadacitinib treatment were similar to what was observed in the rheumatologic disease clinical studies.

Small increases in LDL cholesterol were observed after week 16 in atopic dermatitis studies.

1. RINVOQ Summary of Product Characteristics.

UK-RNQD-220106. Date of preparation: June 2022

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. 
Adverse events should also be reported to AbbVie on GBPV@abbvie.com