UK Clinical Pharmacy Association

Tildrakizumab

Under Review

This monograph is pending review by the Periscope clinical trial team from University of York

Issues for surgery

Risk of perioperative flare in disease activity (potentially leading to an increase in glucocorticoid use) if omitted.

Risk of post-operative infection if continued.

Advice in the perioperative period

Elective surgery

Establish indication and dose frequency (see Further information).

The Surgical Team and patient’s Dermatologist along with the patient should be involved in the planning for elective surgery to balance the potential benefit of preventing post-operative infection by stopping tildrakizumab against the risk of developing severe or unstable disease.

Modifiable risk factors for perioperative infection, such as glycaemic control and smoking should ideally be addressed prior to surgery.

Glucocorticoid use is associated with increased perioperative infection in a dose dependent manner. Where possible consider delaying elective surgery until patients taking tildrakizumab can be managed on less than 15mg prednisolone (or equivalent).

Minor procedures

Consider continuing tildrakizumab before low-risk surgery (i.e. surgery without a break in sterile technique, during which the respiratory, gastrointestinal, and genitourinary tracts are not entered) e.g. endoscopy, bronchoscopy, hysteroscopy, cystoscopy, breast biopsy, dermatologic or ophthalmological procedures.

All other procedures

Surgery should be scheduled to enable the patient to miss ONE dose (i.e., scheduling surgery for a minimum of 12 weeks and 1 day after administration of 12 weekly tildrakizumab).

EXCEPT:

If the Surgical Team deem the procedure to be of especially high infection risk, consider stopping 3-5 half-lives before surgery. Be mindful that a flare in disease activity may occur, which may result in glucocorticoids being administered, further increasing the infection risk (see Further information).

Emergency surgery 

Withhold any doses due in the immediate post-operative period. Monitor closely for infection if patient has received a dose of tildrakizumab in previous 12 weeks.

Perioperative considerations

Control of body temperature and avoidance of blood transfusion may minimise the risk of infection.

Post-operative advice

If stopped, recommence post-operatively when there is evidence of wound healing, all sutures and staples are out, there is no significant swelling, erythema, or drainage, and there is no ongoing nonsurgical site infection. This is typically around 14 days post-operatively.

Interactions with common anaesthetic agents

None.

Interactions with other common medicines used in the perioperative period

None.

Further information

Indications, dosing frequency and half-life

Tildrakizumab is used for plaque psoriasis. Doses are typically administered at week 0 and week 4 then followed by maintenance dosing every 12 weeks. Tildrakizumab has a half-life of approximately 23 days. 

Rationale for recommendations - risk of infection versus risk of disease

The evidence for risk of post-operative infection in patients with psoriasis is minimal and is often extrapolated from other populations. The American Academy of Dermatologists / National Psoriasis Foundation (ADD / NPF) advise bDMARDs can safely be continued before minor surgery. The British Society for Rheumatology (BSR), American College of Rheumatology / American Association of Hip and Knee Surgeons (ACR / AAHKS) and German Society for Rheumatology (GSR) advise planning surgery in most patients for after one dose of bDMARD has been missed when the nadir of the drug is at its lowest. This pragmatic approach seeks to minimise the stopping period and thus the risk of a perioperative flare in symptoms which would result in an increase in glucocorticoid use, which would further increase the risk of infection. However, unlike the rheumatology societies the British Association of Dermatologists and AAD / NPF are more cautious with their recommendations for other surgery, suggesting most patients should stop bDMARD therapy for a period of time equivalent to 3 - 5 half-lives before surgery or the length of the treatment cycle, whichever is longer. Given the lack of robust evidence that a longer interruption of treatment is beneficial this seems an overly cautious approach, and risks a perioperative disease flare, particularly with medications with a long half-life, such as tildrakizumab, which is likely to necessitate glucocorticoid use and subsequently increase the risk of infection. Therefore, for simplicity, and in the absence of evidence to the contrary we have extrapolated the recommendations for rheumatology patients to this patient population despite tildrakizumab not being licensed for, and therefore not specifically included in the rheumatology guidelines.

References

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  2. Al-Janabi, A. and Yiu, ZZN. Biologics in Psoriasis: Updated Perspectives on Long-Term Safety and Risk Management. Psoriasis (Auckl). 2022; 12:1-14 doi:10.2147/PTT.S328575

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  5. Holroyd, CR. Seth, R. Bukhari, M. et al. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis. Rheumatology. 2019; 58:220-226 doi:10.1093/rheumatology/key207

  6. In: Brayfield A (Ed), Martindale: The Complete Drug Reference. London: The Royal Pharmaceutical Society of Great Britain. Electronic version. Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com [Accessed 29th January 2024]

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  8. Moreira P, Correia A, Cerquerira M, Gil M. Perioperative management of disease-modifying antirheumatic drugs and other immunomodulators. ARP Rheumatol. 2022; 3: 218-224.
  9. Menter, A. Strober, BE. Kaplan DH. et al. Derm Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019; 80:1029-1072 doi:10.1016/j.jaad.2018.11.057

  10. Smith, CH. Yiu, ZZN. Bale, T. et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020;183(4):628–637. Doi:10.1111/bjd.19039

  11. Summary of Product Characteristics – Ilumetri® (tildrakizumab) 100 mg solution for injection in pre-filled syringe. Almirall Limited. Accessed via medicines.org.uk 06/02/24[date of revision of the text July 2022]