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Olumiant ® (baricitinib)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Is there a need to stop Olumiant® (baricitinib) prior to surgery? When to stop and restart?
Use of baricitinib has not been systematically studied in the perisurgical setting, but RA guidelines recommend stopping JAK inhibitors 3-4 days prior to surgery and restarting within about 14 days depending on wound healing.
Content Overview
Infection Risk and Immunosuppressive Treatments
Baricitinib Rheumatoid Arthritis Clinical Development Program
- Exclusion Criteria Related to Surgical Procedures
- Administration of Baricitinib in Patients Who Required Surgery During Clinical Trials
- Limited Data Collected in Patients Undergoing Surgical Procedures
Perioperative Recommendations From Rheumatology Organizations
Infection Risk and Immunosuppressive Treatments
Immunosuppressive treatments, including those used to treat rheumatoid arthritis (RA), may increase the risk of perisurgical infections and delay wound healing.1
Serious and sometimes fatal infections have been reported in patients receiving other JAK inhibitors.2
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.2
If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.2
Venous thromboembolism risk
In a retrospective observational study of baricitinib in rheumatoid arthritis patients, a higher rate of venous thromboembolic events (VTE) was observed compared to patients treated with TNF inhibitors.2
In a large randomized active‑controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.2
In patients with cardiovascular or malignancy risk factors, baricitinib should only be used if no suitable treatment alternatives are available.2
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, baricitinib should be used with caution.2
VTE risk factors other than cardiovascular or malignancy risk factors include2
- previous VTE,
- patients undergoing major surgery,
- immobilisation,
- use of combined hormonal contraceptives or hormone replacement therapy, and
- inherited coagulation disorder.
Patients should be re‑evaluated periodically during baricitinib treatment to assess for changes in VTE risk.2
Promptly evaluate patients with signs and symptoms of VTE and discontinue baricitinib in patients with suspected VTE, regardless of dose or indication.2
Baricitinib Rheumatoid Arthritis Clinical Development Program
Exclusion Criteria Related to Surgical Procedures
Patients in the baricitinib phase 3 clinical trials were excluded if they
- had any major surgery within 8 weeks prior to study entry, or
- would require major surgery during the study, that in the opinion of the investigator in consultation with Eli Lilly and Company or its designee would pose an unacceptable risk to the patient.5
Administration of Baricitinib in Patients Who Required Surgery During Clinical Trials
There were no pre-defined criteria for perisurgical administration of baricitinib in the 4 phase 3 clinical trial protocols.5
Administration of baricitinib for patients who required surgery while enrolled in the clinical trials was left to the judgment of the investigator.5
Limited Data Collected in Patients Undergoing Surgical Procedures
The All BARI RA analysis set included 3770 patients with RA who received baricitinib at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with
- 14,744 patient years exposure (PYE) to baricitinib
- 15,114 patient years overall observation including time on baricitinib and follow-up
- median exposure of 4.6 years, and
- maximum exposure of 9.3 years.6
Within the All BARI RA dataset, 122 (3.2%) patients had a temporary interruption of baricitinib due to a medical or surgical procedure.5
Perioperative Recommendations From Rheumatology Organizations
The information provided is for reference only and does not constitute a treatment recommendation from Lilly. Healthcare decisions to prescribe BARI should be based on the best clinical judgment of the prescribing healthcare practitioner.
Perioperative recommendations vary among rheumatology organizations and have historically focused on the use of conventional and biologic disease-modifying antirheumatic drugs (DMARDs).1,4,7,8 More recent guidelines have included preliminary recommendations for newer classes of agents including Janus kinase (JAK) inhibitors.9-11
American College of Rheumatology and the American Association of Hip and Knee Surgeons
A set of guidelines, specifically for patients with rheumatic diseases undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA), was published by the American College of Rheumatology (ACR) and American Association of Hip and Knee Surgeons (AAHKS).9
The 2017 ACR/AAHKS guidelines covered a broad range of antirheumatic drug therapies including DMARDs glucocorticoids, and the JAK inhibitor, tofacitinib.9
Assessment of cardiac risk factors and perioperative venous thromboembolism prophylaxis were not addressed in the 2017 ACR/AAHKS guideline9; however, the expert panel referenced existing published guidelines on these topics.12,13
A full updated guideline from the ACR/AAHKS is expected summer of 2022, but a summary of updates of this guideline is published. Recommendations include patients continue DMARDs through surgery, and to withhold biologics prior to and through surgery.
It is recommended that JAK inhibitors, including baricitinib, be withheld 3 days prior surgery and may be restarted in RA patients once
- the wound shows evidence of healing
- any sutures/staples are out
- there is no significant swelling, erythema or draining, and
- there is no ongoing non-surgical site infection (typically about 14 days).10
Of note, this recommendation is based on infection risk and does not account for the risk of cardiac events or venous thromboembolism.10
Canadian Rheumatology Association and British Society for Rheumatology
The Canadian Rheumatology Association and the British Society for Rheumatology have published recommendations for withholding biologic DMARDs in the perioperative setting based on
Both associations recommend re-starting biologic DMARD therapy upon satisfactory wound healing.4,7,14
Updated guidelines published by the British Society for Rheumatology in 2018 provide recommendations for the timing of surgery based on drug dosing intervals and pharmacokinetic half-lives of various biologic therapies.14
German Society of Rheumatology Monitoring Sheet for Baricitinib
The German Society of Rheumatology (DGRh) publishes monitoring sheets for antirheumatic therapies. These monitoring sheets summarize clinical information including
- recommended dose
- onset of action
- laboratory monitoring
- contraindications
- adverse events, and
- drug-drug interactions.15
Regarding perioperative management, the January 2021 edition of the DGRh monitoring sheet for baricitinib discussed that
- there are not yet sufficient data regarding the risk of infection and wound healing during surgical procedures with baricitinib, and
- considering the half-life, a break of baricitinib is recommended for several days prior to major surgery.15
The DGRh also has a guideline on the perioperative management of patients with rheumatic diseases. The 2021 update recommends that JAK inhibitors should be paused for 3 to 4 days prior to surgery, and start therapy as soon as possible depending on wound healing.11
References
1Goodman SM. Rheumatoid arthritis: perioperative management of biologics and DMARDs. Seminars in Arthritis and Rheumatism. 2015;44(6):627-632. http://dx.doi.org/10.1016/j.semarthrit.2015.01.008
2Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
3Härle P, Straub RH, Fleck M. Perioperative management of immunosuppression in rheumatic diseases—what to do? Rheumatol Int. 2010;30(8):999-1004. http://dx.doi.org/10.1007/s00296-009-1323-7
4Bombardier C, Hazlewood GS, Akhavan P, et al. Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety. J Rheumatol. 2012;39(8):1583-1602. http://dx.doi.org/10.3899/jrheum.120165
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022;81(3):335-343. https://doi.org/10.1136/annrheumdis-2021-221276
7Ledingham J, Deighton C; British Society for Rheumatology Standards, Guidelines and Audit Working Group. Update on the British Society for Rheumatology guidelines for prescribing TNFalpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology (Oxford). 2005;44(2):157-163. http://dx.doi.org/10.1093/rheumatology/keh464
8Ledingham J, Gullick N, Irving K, et al. BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs. Rheumatology (Oxford). 2017;56(6):865-868. https://doi.org/10.1093/rheumatology/kew479
9DO NOT USE: Goodman SM, Springer B, Guyatt G, et al. 2017 American College of Rheumatology/American Association of Hip and Knee Surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective total hip or total knee arthroplasty. Arthritis Care Res (Hoboken). 2017;69(8):1111-1124. http://dx.doi.org/10.1002/acr.23274
102022 American college of rheumatology/American association of hip and knee surgeons guideline for the perioperative management of antirheumatic medication in patients with rheumatic diseases undergoing elective or total hip or total knee arthroplasty. Guideline summary. Updated March 17, 2022. Accessed June 2, 2022. https://www.rheumatology.org/Portals/0/Files/Perioperative-Management-Guideline-Summary.pdf
11Albrecht K, Poddubnyy D, Leipe J, et al. Perioperative handling of the therapy of patients with inflammatory rheumatic diseases: Updated recommendations of the German Society of Rheumatology. J Rheumatol. 2022;81:212-224. https://doi.org/10.1007/s00393-021-01140-x
12Fleisher LA, Beckman JA, Brown KA, et al. 2009 ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;54(22):e13-e118. https://doi.org/10.1016/j.jacc.2009.07.010
13Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed. American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2 suppl):e278S-e325S. https://doi.org/10.1378/chest.11-2404
14Holroyd CR, Seth R, Bukhari M, et al. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis-Executive summary. Rheumatology (Oxford). 2019;58(2):220-226. https://doi.org/10.1093/rheumatology/key207
15The German Society of Rheumatology (DGRh): monitoring sheets for therapies approved in Germany. January 2021. Accessed June 2, 2022. https://dgrh.de/dam/jcr:468986c8-6516-4b39-9aaf-4d9d6fdf30e2/Baricitinib_Arzt_01_21.pdf
Date of Last Review: 02 June 2022