Olumiant ® (baricitinib) tabletter

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Olumiant®▼ (baricitinib): Användning hos patienter som genomgår kirurgiska ingrepp

Användning av baricitinib har inte studerats systematiskt i perioperativ miljö.

Infection Risk and Immunosuppressive Treatments

Immunosuppressive treatments, including those used to treat 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 BARI 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 BARI in the 4 phase 3 clinical trial protocols.4

Administration of BARI 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 integrated safety dataset included 3439 patients with RA who received BARI at a variety of doses at all exposure time points through 01 January 2016 in phase 2 and phase 3 studies.4

This summary includes information on investigational doses. The recommended dose of BARI is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.5

Within the All BARI RA dataset, 43 patients had a total of 79 treatment interruptions due to a medical or surgical procedure.4

The mean (SD) duration of each individual treatment interruption was 22.3 (21.6) days.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 DMARDs.1,3,6-8 More recent guidelines have included preliminary recommendations for newer classes of agents including JAK inhibitors.9

American College of Rheumatology and the American Association of Hip and Knee Surgeons

Guidance related to perioperative infection risk, published by the ACR in 2008, recommended that biologic DMARDs should not be used for at least 1 week prior to and 1 week after surgery, with longer withholding intervals suggested for treatments with longer half-lives.7

  • The 2008 ACR expert panel did not provide a recommendation regarding the use of non-biologic DMARDs, citing lack of consistent evidence.7

A set of guidelines, specifically for patients with rheumatic diseases undergoing elective THA or TKA, was recently published by the AAHKS.9

  • Although specific to adult patients with THA or TKA, the 2017 ACR/AAHKS guidelines covered a broad range of antirheumatic drug therapies including

    • conventional DMARDs

    • biologic DMARDs

    • glucocorticoids, and

    • the JAK inhibitor, tofacitinib.9

  • Similar to guidelines from other rheumatology organizations, highlighted key factors driving clinical decision-making about when to stop and restart antirheumatic drugs include

    • disease flare

    • wound healing, and

    • particularly infection risk.9

  • Preliminary recommendations for stopping the JAK inhibitor tofacitinib prior to surgery were discussed in the context of

    • short serum half-life

    • increased risk of infection, and

    • duration of immunosuppression after interruption of therapy.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.10,11

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.3,6,12

Both associations recommend re-starting biologic DMARD therapy upon satisfactory wound healing.3,6,12

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.12

Both associations also provided guidance for perioperative management of the conventional DMARDs, including methotrexate.3,8

German Society of Rheumatology Monitoring Sheet for Baricitinib

The 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.13

With respect to perioperative management, the July 2017 edition of the DGRh monitoring sheet for BARI discussed that

  • there is a lack of clinical evidence regarding the effects of BARI therapy on perioperative risk, and

  • considering the half-life, stop BARI therapy 3 to 4 days before surgery and restart therapy after wound healing is complete.13

Published Systematic Reviews of Perioperative Infection Risk

Summary of Published Systematic Reviews

The authors of the review articles detailed below have acknowledged that more work is needed to produce a clear evidence-based approach for the optimal perioperative use of DMARDs in patients with RA.1,2

Given the lack of established guidance, the authors suggested that perioperative management requires close communication between the rheumatologist and the surgeon, with consideration for the many individual patient factors that may affect the balance between inflammatory disease flare and risk of infection.1,2

Baker 2019

In a recent literature review, authors suggested that holding biologic DMARD doses may not have a meaningful impact on post-surgical infection risk.14

The authors concluded that observational data supported recommendations to continue treatments in the perioperative period with only short interruptions of biologic DMARDs and other potent immunosuppressants.14

Baricitinib is not referred to specifically in the article; however, tofacitinib is mentioned in the context of the ACR/AAHKS guidelines within the article.14

Goodman 2015

In a review of arthroplasty in RA patients, the author provided general guidelines for stopping treatment based in part on the pharmacologic properties of a variety of conventional and biologic DMARDs, as well as restarting treatment once the wound has healed.1

The author acknowledged that clinical data regarding the optimal time to stop and restart DMARDs were lacking, with most evidence limited to expert opinion from

  • observational studies

  • case-control studies, and

  • meta-analysis.1

Supporting data for JAK inhibitors were not included in the review; however, the author suggested that, in the case of the JAK inhibitor tofacitinib, pharmacologic half-life should be considered when determining the duration of time sufficient to mitigate infection risk.1

Härle 2010

Härle et al reviewed the published data available on conventional and biologic DMARDs and described an approach to limit the risk of infections while avoiding inflammatory exacerbation.2

The authors acknowledged a lack of randomized controlled studies, and therefore the absence of an evidence-based approach for the use of DMARDs in the perioperative setting.2

JAK inhibitors were not addressed.2

References

1. Goodman 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

2. Härle 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

3. Bombardier 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

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

5. Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

6. Ledingham 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

7. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784. http://dx.doi.org/10.1002/art.23721

8. Ledingham 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

9. 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

10. Fleisher 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:e13–118. https://doi.org/10.1016/j.jacc.2009.07.010

11. Falck-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(suppl 2):e278S-325S. https://doi.org/10.1378/chest.11-2404

12. Holroyd 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

13. The German Society of Rheumatology (DGRh): Monitoring sheets for therapies approved in Germany - website. https://dgrh.de/Start/Versorgung/Therapieüberwachung/Therapieüberwachungsbögen.html. Accessed June 20, 2019.

14. Baker JF, George MD. Prevention of Infection in the Perioperative Setting in Patients with Rheumatic Disease Treated with Immunosuppression. Curr Rheumatol Rep. 2019;21:17. https://doi.org/10.1007/s11926-019-0812-2

Glossary

AAHKS = American College of Rheumatology (ACR)/American Association of Hip and Knee Surgeons

ACR = American College of Rheumatology

BARI = baricitinib

DGRh = German Society of Rheumatology

DMARD = disease-modifying antirheumatic drug

JAK = Janus kinase

RA = rheumatoid arthritis

TKA = total knee arthroplasty

THA = total hip arthroplasty

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M05 22


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