Monitoring the transition of patients on biologics in rheumatoid arthritis: Consensus guidance for pharmacists

Main Article Content

Keywords

Consensus, Algorithms, Biosimilar Pharmaceuticals, Janus Kinase Inhibitors, Drug Substitution, Antirheumatic Agents, Arthritis, Rheumatoid, Nocebo Effect, Pharmacists, Rheumatologists, Clinical Competence, Group Processes, Canada

Abstract

Background: Recent approvals for novel agents such as the small molecule Janus kinase inhibitors (JAKi), combined with the advent of biosimilars has widened the gamut of available therapeutic options in the treatment of rheumatoid arthritis (RA). This combined with the introduction of mandatory non- medical switches to biosimilars in some jurisdictions by both public and private payors has led to a significant increase in the volume of therapeutic changes for patients. Pharmacists are well positioned to ensure effective and safe transitions, however there is a significant unmet need for objective and subjective clinical guidance around therapy as well disease state monitoring in RA that facilitates best practices throughout the patient journey.


Objective: In this paper we aim to create a consensus derived monitoring algorithm for pharmacists to facilitate best practices throughout therapeutic transitions from originator biologic to other originator biologics, biosimilars, and Janus kinase inhibitors in RA.


Methods: The Nominal Group Technique (NGT) was used to understand if consensus could be found among the participants. Clinically relevant questions were developed to capture solutions to the identified unmet need. The faculty considered the questions as individuals, and privately generated answers/ideas. After discussion and consideration, the participants ranked the ideas and established a consensus.


Results: Based on the outcome of the consensus discussions, an algorithm was created to help guide pharmacists through therapeutic transitions in RA. The tool covers important topics such as pre-transition considerations, avoiding the nocebo effect for biosimilars, specific considerations for each drug or class, monitoring efficacy, and when to refer.


Conclusions: New classes of anti-rheumatic drugs including JAKi, along with the introduction of biosimilars are presenting more opportunity for therapeutic changes and monitoring in patients with RA. We hope our evidence-based consensus derived guidance tool will assist frontline pharmacists in supporting their patients to a successful therapeutic transition in RA.

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References

1. Kuek A, Hazleman BL, Ostör AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J. 2007;83(978):251-260. https://doi.org/10.1136/pgmj.2006.052688
2. Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1(Suppl 1):S1. https://doi.org/10.1186/ar2666
3. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699. https://doi.org/10.1136/annrheumdis-2019-216655
4. Government of Alberta. Biosimilar drugs. https://www.alberta.ca/biosimilar-drugs.aspx (accessed Oct 28, 2020).
5. British Columbia Government. Biosimilars FAQ for prescribers. https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/biosimilars-initiative-prescribers/biosimilars-faq-prescribers#PSP (accessed Jul 7, 2020)
6. Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111-5117. https://doi.org/10.1182/blood-2012-04-425744
7. Kim JW, Jung JY, Suh CH. Real-world observational study of biosimilars in inflammatory arthritis treatment: a systematic literature review. Expert Opin Biol Ther. 2021;21(1):57-73. https://doi.org/10.1080/14712598.2020.1812575
8. Mansell K, Bhimji H, Eurich D, Mansell H. Potential cost-savings from the use of the biosimilars filgrastim, infliximab and insulin glargine in Canada: a retrospective analysis. BMC Health Serv Res. 2019;19(1):827. https://doi.org/10.1186/s12913-019-4680-2
9. Mezones-Holguin E, Gamboa-Cardenas RV, Sanchez-Felix G, et al. Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country. Front Pharmacol. 2019;10:1010. https://doi.org/10.3389/fphar.2019.01010
10. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes. Drugs. 2018;78(4):463-478. https://doi.org/10.1007/s40265-018-0881-y
11. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304-2316. https://doi.org/10.1016/s0140-6736(17)30068-5
12. Gerdes S, Thaçi D, Griffiths CEM, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32(3):420-427. https://doi.org/10.1111/jdv.14605
13. Toussirot E, Marotte H. Switching from originator biological agents to biosimilars: what is the evidence and what are the issues?. RMD Open. 2017;3(2):e000492. https://doi.org/10.1136/rmdopen-2017-000492
14. Kristensen LE, Alten R, Puig L, et al. Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent. BioDrugs. 2018;32(5):397-404. https://doi.org/10.1007/s40259-018-0306-1
15. FDA. Biosimilar and interchangeable biologics: more treatment choices. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices (accessed Jul 8, 2020).
16. Foreman E, Patel H, Siderov J, Harchowal J, Bubalo J, Chan A. A survey of global biosimilar implementation practice conducted by the International Society of Oncology Pharmacy Practitioners. J Oncol Pharm Pract. 2020;26(3_suppl):22-32. https://doi.org/10.1177/1078155220913098
17. Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(Suppl 3):S123-S132. https://doi.org/10.1002/jcph.339
18. Endrenyi L, Jamali F, Loebenberg R. Subsequent Entry Biologics in Canada: Current State of the Science. J Pharm Pharm Sci. 2015;18(2):177-183. https://doi.org/10.18433/j38s3h
19. Nominal group technique (ngt): nominal brainstorming steps. https://asq.org/quality-resources/nominal-group-technique (accessed Oct 19, 2020).
20. Harvey N, Holmes CA. Nominal group technique: an effective method for obtaining group consensus. Int J Nurs Pract. 2012;18(2):188-194. https://doi.org/10.1111/j.1440-172x.2012.02017.x
21. McMillan SS, King M, Tully MP. How to use the nominal group and Delphi techniques. Int J Clin Pharm. 2016;38(3):655-662. https://doi.org/10.1007/s11096-016-0257-x
22. CDC. Gaining consensus among stakeholders through the nominal group technique. https://www.cdc.gov/healthyyouth/evaluation/pdf/brief7.pdf (accessed Jun 3, 2021).
23. Charmaz K, Belgrave LL. Grounded theory. In: Ritzer G, ed. The Blackwell encyclopedia of sociology. Hoboken, NJ: Wiley; 2015. ISBN: 9781405124331
24. Interactive presentation software: Mentimeter. https://www.mentimeter.com/ (accessed Oct 28, 2020).
25. Pouillon L, Socha M, Demore B, et al. The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol. 2018;14(9):739-749. https://doi.org/10.1080/1744666x.2018.1512406
26. Edwards CJ, Hercogová J, Albrand H, Amiot A. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opin Biol Ther. 2019;19(10):1001-1014. https://doi.org/10.1080/14712598.2019.1610381
27. The Arthritis Society. The Arthritis Society position on biosimilars. https://www.arthritis.ca/AS/media/pdf/Treatment/Biosimilars-Position-Paper-January-2018-FINAL-EN.PDF (accessed Oct 28, 2020).
28. Rezk MF, Pieper B. Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect. Rheumatol Ther. 2017;4(2):209-218. https://doi.org/10.1007/s40744-017-0085-z
29. Kay J, Schoels MM, Dörner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2018;77(2):165-174. https://doi.org/10.1136/annrheumdis-2017-211937
30. Barbier L, Ebbers HC, Declerck P, Simoens S, Vulto AG, Huys I. The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review. Clin Pharmacol Ther. 2020;108(4):734-755. https://doi.org/10.1002/cpt.1836
31. Vandenplas Y, Simoens S, Van Wilder P, Vulto AG, Huys I. Informing Patients about Biosimilar Medicines: The Role of European Patient Associations. Pharmaceuticals (Basel). 2021;14(2):117. https://doi.org/10.3390/ph14020117
32. Abbvie Corporation. Humira Product Monograph. https://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/HUMIRA_PM_EN.pdf (accessed Oct 28, 2020).
33. ULC PC. Xeljanz Product Monograph. https://www.pfizer.ca/sites/default/files/201910/XELJANZ_PM_E_230976_24Oct2019.pdf (accessed Oct 28, 2020).
34. Roche H-L. Rituxan Product Monograph. Toxicology. https://www.rochecanada.com/PMs/Rituxan/RituxanIV_PM_E.pdf (accessed Oct 28, 2020).
35. Canada B-MS. Orencia Product monograph. https://www.bms.com/assets/bms/ca/documents/productmonograph/ORENCIA_EN_PM.pdf (accessed Oct 28, 2020).
36. Swedish Orphan Biovitrum. Kinaret Product monograph. https://pdf.hres.ca/dpd_pm/00044494.PDF (accessed Oct 28, 2020).
37. Bolognese JA, Schnitzer TJ, Ehrich EW. Response relationship of VAS and Likert scales in osteoarthritis efficacy measurement. Osteoarthr Cartil. 2003;11(7):499-507. https://doi.org/10.1016/S1063-4584(03)00082-7
38. Pincus T, Yazici Y, Bergman MJ. RAPID3, an index to assess and monitor patients with rheumatoid arthritis, without formal joint counts: similar results to DAS28 and CDAI in clinical trials and clinical care. Rheum Dis Clin North Am. 2009;35(4):773-778. https://doi.org/10.1016/j.rdc.2009.10.008