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Upadacitinib: A Successor to adalimumab?

Upadacitinib: A Successor to adalimumab?. Miranda Ochs, PharmD PGY-1 Pharmacy Resident Millcreek Community Hospital October 26, 2019. Objectives. Following the presentation, pharmacists will be able to Identify appropriate dosing and monitoring for patients taking upadacitinib

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Upadacitinib: A Successor to adalimumab?

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  1. Upadacitinib: A Successor to adalimumab? Miranda Ochs, PharmD PGY-1 Pharmacy Resident Millcreek Community Hospital October 26, 2019

  2. Objectives • Following the presentation, pharmacists will be able to • Identify appropriate dosing and monitoring for patients taking upadacitinib • Explain upadacitinib's place in the treatment of rheumatoid arthritis • Following the presentation, pharmacy technicians will be able to • Describe appropriate storage requirements for upadacitinib • Recognize available preparations of upadacitinib

  3. upadacitinib MONOGRAPH OVERVIEW

  4. UpadacitinibGeneral information • Brand name: RINVOQ™ • Indication • Moderate-severe rheumatoid arthritis in patients that have had an inadequate response or intolerance to methotrexate • Monotherapy or in combination with nonbiologic agent • Pharmacologic category: Disease modifying antirheumatic drug (DMARD) • Janus Associated Kinase (JAK) inhibitor • Mechanism of action • Inhibits JAK enzymes involved with hematopoiesis and immune cell function • Decreased immune cell production  decreased inflammatory response  improved symptoms RINVOQ™ (upadacitinib) Treatment for Rheumatoid Arthritis. Rinvoq. https://www.rinvoq.com/. Accessed October 5, 2019.

  5. Upadacitinibdosing • Dosage • 15 mg tablet by mouth once daily • Dosage adjustments • No renal dosing recommendations; not studied in eGFR <15 ml/min/1.73 m2 • Not recommended in severe liver impairment (Child-Pugh class C) • Formulations • Extended release tablet A15 Pill Images (Purple / Capsule-shape). Drugs.com. https://www.drugs.com/imprints/a15-29542.html. Accessed October 11, 2019.

  6. Upadacitinibpatient management Side effects Monitoring and Screening • Upper respiratory tract infection • Nausea • Cough • Pyrexia • Lymphocyte, neutrophil counts • Liver function tests (LFTs) at baseline and as clinically indicated • Lipids 12 weeks after initiation and periodically thereafter

  7. Upadacitinibwarnings Boxed warnings precautions • Infection • Malignancy • Thrombosis • Tuberculosis • Contraindications: none • Gastrointestinal perforation • Hematological toxicity • Do not initiate if absolute lymphocyte count <500/mm3, ANC <1,000/mm3, or hemoglobin <8 g/dL • Increased LFTs • Lipid abnormalities

  8. Upadacitinibstorage and administration • Swallowed whole with or without food • Do not crush, split, or chew • Storage • Room temperature in original bottle • Not on the 2016 National Institution for Occupational Safety and Health (NIOSH) list of hazardous drugs • Qualifying criteria: carcinogenicity, teratogenicity • Use appropriate precautions during handling • Assessment of risk • Dispense in original bottle

  9. USE IN PRACTICE CLINICAL IMPLICATIONS

  10. treatment of rheumatoid arthritis • Rheumatoid arthritis: painful inflammatory disorder affecting joints • First line  DMARD monotherapy • Methotrexate (MTX) • Hydroxychloroquine • Sulfasalazine • Leflunamide • Continued moderate or high disease activity? • Combination DMARD therapy • TNF inhibitor +/- methotrexate • Non-TNF biologic +/- methotrexate ADALIMUMAB • Figure 3. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016;68(1):9.

  11. A successor to ADALIMUMAB? • Upadacitinib and adalimumab share placement in the algorithm for treatment of rheumatoid arthritis • Adalimumab: weekly or biweekly self-injection • Upadacitinib: once daily pill • Upadacitinib shown to be superior to adalimumab with regards to American College of Rheumatology (ACR) 20/50/70 achievement • Achievement of ACR 20/50/70 correlates with a 20%/50%/70% improvement in symptoms (i.e. swollen joints, pain)

  12. SELECT-COMPARE trial • Randomized, double-blind study evaluating effects of upadacitinib, placebo, and adalimumab in patients with moderate-severe rheumatoid arthritis on MTX • 2:2:1 randomization • Upadacitinib vs placebo vs adalimumab • Primary endpoint: ACR20 response at week 12 in upadacitinib + MTX vs adalimumab + MTX • 63% achievement of ACR20 in adalimumab vs 71% in upadacitinib • Secondary endpoint: ACR50 response at week 12 in upadacitinib + MTX vs adalimumab + MTX • 29% achievement of ACR50 in adalimumab vs 45% in upadacitinib (P≤0.001)

  13. Question #1 • A 45 year old female brings in four new prescriptions. After reviewing them, it is determined the physician needs to be contacted. What is the problem with the following regimen? • Upadacitinib 15 mg by mouth once daily for initiation of therapy • Certolizumab 200 mg subcutaneously every two weeks for continuation of therapy • Methotrexate 15 mg by mouth once weekly for continuation of therapy • Folic acid 1 mg by mouth daily • Inappropriate dosing: the methotrexate should be 20 mg daily • Drug interaction: folic acid can’t be taken with methotrexate • Upadacitinib can’t be taken with certolizumab • The prescription for upadacitinib needs to be sent to a specialty pharmacy for compounding

  14. Question #1 • A 45 year old female brings in four new prescriptions. After reviewing them, it is determined the physician needs to be contacted. What is the problem with the following regimen? • Upadacitinib 15 mg by mouth once daily for initiation of therapy • Certolizumab 200 mg subcutaneously every two weeks for continuation of therapy • Methotrexate 15 mg by mouth once weekly for continuation of therapy • Folic acid 1 mg by mouth daily • Inappropriate dosing: the methotrexate should be 20 mg daily • Drug interaction: folic acid can’t be taken with methotrexate • Upadacitinib can’t be taken with certolizumab • The prescription for upadacitinib needs to be sent to a specialty pharmacy for compounding

  15. Question #2 What consideration must be taken when dispensing upadacitinib? • Must be stored in the refrigerator until dispensed • Must be mixed before dispensing to patient • Pennsylvania Drug Monitoring Program (PDMP) needs to be checked before dispensing • Must be dispensed in the original container

  16. Question #2 What consideration must be taken when dispensing upadacitinib? • Must be stored in the refrigerator until dispensed • Must be mixed before dispensing to patient • Pennsylvania Drug Monitoring Program (PDMP) needs to be checked before dispensing • Must be dispensed in the original container

  17. conclusion • Upadacitinib is a new biologic DMARD indicated for the treatment of rheumatoid arthritis in patients who have had an inadequate response to or cannot tolerate methotrexate • Upadacitinib can be used as monotherapy or combination therapy • Administered as a single pill once day • Upadacitinib may require handling precautions in accordance with USP <800> • Clinical data is proving upadacitinib to be superior to adalimumab in the treatment of rheumatoid arthritis and may become a preferred agent.

  18. Upadacitinib: A Successor to ADALIMUMAB? Miranda Ochs, PharmD PGY-1 Pharmacy Resident Millcreek Community Hospital October 26, 2019

  19. references • <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2018:84-103. • Figure 3. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016;68(1):9. • Fleischmann R, Pangan AL, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Zhou Y, Othman AA, Song IH, Genovese MC. A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/a-phase-3-randomized-double-blind-study-comparing-upadacitinib-to-placebo-and-to-adalimumab-in-patients-with-active-rheumatoid-arthritis-with-inadequate-response-to-methotrexate/. Accessed October 5, 2019. • Humira (adalimumab) [product monograph]. St-Laurent, Quebec, Canada: AbbVie Corporation; June 2019. • Rinvoq (upadacitinib) [prescribing information]. North Chicago, IL: AbbVie Inc; August 2019. • RINVOQ™ (upadacitinib) Treatment for Rheumatoid Arthritis. Rinvoq. https://www.rinvoq.com/. Accessed October 5, 2019. • Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016;68(1):1-25. • Taylor P. AbbVie prices Rinvoq close to Humira after arthritis approval. pharmaphorum. https://pharmaphorum.com/news/abbvie-prices-upadacitinib-close-to-humira-after-arthritis-approval/. Published August 19, 2019. Accessed October 5, 2019. • US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 6, 2019.

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