Overview

Guselkumab (Tremfya^®) is an anti-interleukin-23 monoclonal antibody indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Background

In October 2019, the National Pharmaceutical Regulatory Agency (NPRA) received a safety issue notification from the product registration holder of Tremfya^®, Johnson & Johnson Sdn. Bhd. regarding the association of guselkumab with the risk of anaphylaxis.

Serious hypersensitivity reactions are a known safety risk for all biologics.¹ Treatment with monoclonal antibodies may be associated with the development of antibodies against the therapeutic agent, which increases the chances of experiencing hypersensitivity reactions.

In the post-marketing surveillance of guselkumab, spontaneous reports of anaphylaxis and anaphylactic reactions have been received.¹ Although anaphylactic reactions generally occur shortly (minutes to hours) after therapeutic monoclonal antibodies exposure, there were some serious hypersensitivity reactions reported to occur several days after guselkumab treatment, including cases with urticaria and dyspnoea. Based on the evaluation of these cases, anaphylaxis/anaphylactic reaction was determined to be a new adverse drug reaction for guselkumab, and an update of the product information is warranted.²

Adverse Drug Reaction Reports:

To date, there is no local adverse drug reaction report received for guselkumab.³

On the World Health Organisation (WHO) ADR database, there were a total of 3,042 reports associated with guselkumab use, where three (3) adverse events were reported as anaphylactic shock.⁴

Advice for Healthcare Professionals: 

• Guselkumab continues to have a favourable benefit-risk profile for the approved indication.
• Advice patients to immediately seek emergency treatment if they develop signs of anaphylaxis, such as difficulty breathing, swollen face, swollen tongue, or throat tightness.⁵
• If serious hypersensitivity reactions such as anaphylaxis occur, treatment with Tremfya^® should be discontinued and appropriate therapy should be instituted. The prescriber of Tremfya^® must be informed.
• Please report all adverse events suspected to be related to the use of guselkumab to NPRA.

References:

1. Sala-Cunill A, Luengo O, Cardona V (2019). Biologics and anaphylaxis. Curr Opin Allergy Clin Immunol.19(5):439-446.
2. Johnson & Johnson Sdn. Bhd. (October 2019). Notification of Safety Issue Related to Guselkumab. Ref. No.: NPRA/PV/2019/065.
3. The Malaysian Adverse Drug Reactions Database, NPRA. [Accessed: February 2020].
4. VigiLyze Uppsala Monitoring Centre, World Health Organisation. [Accessed: February 2020].
5. British Assocition of Dermatologists (2019). Guselkumab leaflet. http://www.bad.org.uk/shared/get-file.ashx?id=6337&itemtype=document [Accessed: March 2019].

DISCLAIMER:

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.