Olumiant ® (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing 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.

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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

Determining when and how long to withhold immunosuppressive RA treatments involves balancing the risk of inflammatory disease flare and the risk of infection.1-3

Some factors to consider in determining perisurgical dosing modifications of medications used to treat RA include

  • the type and nature of surgery
  • presence of comorbid diseases
  • inflammatory disease status
  • history of wound infections, and
  • the pharmacokinetic properties of the RA medication.2,3

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.4

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.4

Administration of baricitinib for patients who required surgery while enrolled in the clinical trials was left to the judgment of the investigator.4

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.5

Within the All BARI RA dataset, 122 (3.2%) patients had a temporary interruption of baricitinib due to a medical or surgical procedure.4

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).1,3,6,7 More recent guidelines have included preliminary recommendations for newer classes of agents including Janus kinase (JAK) inhibitors.8-10

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).8

The 2017 ACR/AAHKS guidelines covered a broad range of antirheumatic drug therapies including DMARDs glucocorticoids, and the JAK inhibitor, tofacitinib.8

Assessment of cardiac risk factors and perioperative venous thromboembolism prophylaxis were not addressed in the 2017 ACR/AAHKS guideline8; however, the expert panel referenced existing published guidelines on these topics.11,12

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).9

Of note, this recommendation is based on infection risk and does not account for the risk of cardiac events or venous thromboembolism.9

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

  • type of surgery
  • patient factors, and
  • pharmacokinetic parameters of the medications.3,6,13

Both associations recommend re-starting biologic DMARD therapy upon satisfactory wound healing.3,6,13

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.13

Both associations also provided guidance for perioperative management of the conventional DMARDs, including methotrexate, but do not list specific recommendations for JAK inhibitors.3,7

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.14

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.14

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.10

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

2Härle 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

3Bombardier 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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Taylor 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

6Ledingham 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

7Ledingham 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

8Goodman 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

92022 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

10Albrecht 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

11Fleisher 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

12Falck-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

13Holroyd 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

14The 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


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