Inflammatory Disorders: Drug Therapy Advancements in Specialty Pharmacy Michael McCall, Pharm.D. January 26, 2019 Today’s Speaker

Michael McCall, Pharm.D. PGY1 Pharmacy Resident Duquesne University | AllianceRx Walgreens Prime Disclosures

No disclosure to report Learning Objectives

Upon completion of this activity, participants should be able to:

• Explain the inflammatory pathway involved in the pathogenesis of rheumatoid arthritis, , and inflammatory bowel disease • Review the current treatment options for the management of patients with rheumatoid arthritis, psoriasis, and inflammatory bowel disease • Describe the advancements in drug therapy and compare their use in treatment to recommend an appropriate regimen based on a patient case • Evaluate the role of specialty pharmacies in the management of patients with rheumatoid arthritis, psoriasis, and inflammatory bowel disease and their impact on patient outcomes Rheumatoid Arthritis Pathogenesis – Rheumatoid Arthritis4,6,7

• Repeated activation of • Auto-immune inflammatory cascade • T and B cells, plasma cells, macrophages, dendritic cells ,synoviocytes • Recognition of self proteins as foreign • Auto-antibody production  immune complexes • Synovial joint inflammation • Multiple joints affected • Small joints progressing to larger joints • Erosion of cartilage and bone • Cytokines • Osteoclast stimulation Current Drug Therapy – Rheumatoid Arthritis9,10

• First line • Conventional disease modifying anti-rheumatic drugs (cDMARD) • Methotrexate (MTX), leflunomide, hydroxychloroquine, sulfasalazine • Second line • TNFα-inhibitor alone or in combination with MTX • , , etanercept, , • Failure on TNFα-inhibitor • IL-6 inhibitor or JAK inhibitor • Guidelines prefer IL-6 inhibitors • Other drug therapies • Abatacept, rituximab • • Immunosuppressants IL-6 inhibitors – Rheumatoid Arthritis11-14

• (Actemra®) • Dosing information • 162 mg subcutaneously (SC) every other week; may increase to weekly • 4 mg/kg intravenously (IV) every 4 weeks; may increase to 8 mg/kg every 4 weeks • Safety • Gastrointestinal perforations • Development of multiple sclerosis • Serious infections – 3.8% of patients (SUMMACTA) • Efficacy – ACR20 (%) • Tocilizumab ± MTX > MTX in naïve and experienced patients • Tocilizumab effective treatment in patents with an inadequate response to TNFα-inhibitors • Tocilizumab > adalimumab in patients intolerant to MTX IL-6 inhibitors – Rheumatoid Arthritis15-18

Sarilumab (Kevzara®) • Dosing Information • 200 mg SC once every two weeks. May decrease to 150 mg SC every two weeks • Safety • Gastrointestinal perforations • Serious infections – 2.6 to 4% of patients (MOBILITY) • Efficacy – ACR20 (%) • > MTX monotherapy when added as combination • Sarilumab + DMARD effective in patients with an inadequate response to TNFα-inhibitors • Sarilumab > adalimumab in patients with an inadequate response to MTX JAK inhibitors – Rheumatoid Arthritis20-23

• Tofacitinib (Xeljanz®) • Dosing information • 5 mg PO twice daily or 11 mg PO once daily (XR) • Safety • Malignancies • Serious infections – 2.5% of patients (ORAL START) • Comparable discontinuation rates due to adverse events • Efficacy – ACR20 (%) • Tofacitinib effective in patients with an inadequate response to non-biologic or biologic • Tofacitinib > MTX in naïve patients • Tofacitinib + MTX non-inferior to adalimumab + MTX JAK inhibitors – Rheumatoid Arthritis24,25

• Baricitinib (Olumiant®) • Dosing information • 2 mg PO once daily • Safety • Malignancies • Serious infections – 2% of patients (RA-BEAM) • Thrombosis – DVT and PE • Efficacy – ACR20 (%) • Baricitinib + MTX > MTX in patients with an inadequate response to MTX or other cDMARD • Baricitinib > adalimumab in patients with an inadequate response to MTX or other cDMARD Case 1 – Rheumatoid Arthritis

BT is a 57 year-old female with a 15 year history of rheumatoid arthritis. Her previous treatments include methotrexate (MTX), adalimumab, and abatacept. She is currently being treated with certolizumab and still experiencing moderate RA symptoms including pain, joint swelling, and morning stiffness. BT’s rheumatologists would like to switch her to another to better control her disease activity.

What is an appropriate treatment option? A. Golimumab B. Anakinra C. Tocilizumab D. Tofacitinib Psoriasis Epidemiology - Psoriasis26

• Affects approximately 7.5 millions Americans • Men and women equally • Develops between ages 15 and 35 • Beyond a cosmetic concern • Mental health - twice as likely to become depressed • Decreased work productivity – 60% of patients missed work due to condition • Cardiovascular disease – 58% more likely to have an event • Development of psoriatic arthritis • Estimated 10 to 30% of patients • Usually develops 10 years after psoriasis Pathogenesis - Psoriasis27

• Immune stimulation in the epidermal layers of the skin • Microbial invasion and cytokine infiltration • Proliferation and thickening of keratinocytes • Inflammation of the skin • Causes raised, red patches that can be itchy and painful • Commonly appears on elbows, knees, or scalp • Five types of psoriasis • Plaque psoriasis • Guttate psoriasis • Inverse psoriasis • Pustular psoriasis • Erythrodermic psoriasis Current Drug Therapy – Psoriasis28

Topicals • Corticosteroids, vitamin D analogues, retinoids Targeted phototherapy • Excimer laser Phototherapy • UVB • PUVA (psoralen + UVA) Systemic agents • Retinoids, immunosuppressants Biologics • TNFα-inhibitors • Adalimumab, etanercept, certolizumab pegol, infliximab • inhibitors IL-23/12 inhibitors - Psoriasis46,47

• (Stelara®) • Dosing information • Induction dose: 45 mg or 90 mg SC at weeks 0 and 4 • Maintenance dose: 45 mg or 90 mg SC every 12 weeks thereafter, starting at week 16 • Safety • Reversible Posterior Leukoencephalopathy Syndrome • Non-infectious pneumonia • Efficacy – PASI 75 (%) • Ustekinumab > placebo at week 12 and 40 PASI 75 response • Ustekinumab > etanercept at week 12 PASI 75 response IL-17 inhibitors - Psoriasis30-33

• (Cosentyx®) • Dosing information • Induction: 300 mg SC at weeks 0, 1, 2, 3, 4 • Maintenance: 300 mg SC every 4 weeks • Safety • Infections – oral candidiasis • Exacerbation of inflammatory bowel disease • Efficacy • Secukinumab > etanercept in week 12 PASI 75 response • Secukinumab > ustekinumab in week 16 PASI 90 response • Results maintained at 1 year – PASI 90 76% IL-17 inhibitors - Psoriasis34-36

• (Taltz®) • Dosing information • Induction: 160 mg SC at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10 and 12 • Maintenance: 80 mg SC every 4 weeks • Safety • Infections – oral candidiasis • Exacerbation of inflammatory bowel disease • Efficacy • Ixekizumab > placebo and etanercept in week 12 PASI 75 response • Maintenance of PASI 75 and PASI 90 up to 60 weeks IL-17 inhibitors - Psoriasis37,38

• Brodalumab (Siliq®) • Dosing information • Induction: 210 mg SC at weeks 0, 1, and 2 • Maintenance: 210 mg SC every 2 weeks • Safety • Suicidal behaviors and ideation – REMS • Risk of flares following discontinuation • Efficacy • Brodalumab > placebo in week 12 PASI 75 response • Brodalumab > ustekinumab in week 12 PASI 100 response IL-23 inhibitors – Psoriasis40-43

• (Tremfya®) • Dosing information • Induction: 100 mg SC at weeks 0 and 4 • Maintenance: 100 mg SC every 8 weeks • Safety • Adverse events comparable to adalimumab and ustekinumab • Efficacy • Guselkumab > adalimumab in week 16 and 24 PASI 90 response • Results maintained for up to two years – PASI 90 82% • Guselkumab > ustekinumab in week 52 PASI 90 response • Switch to guselkumab or remain on ustekinumab IL-23 inhibitors – Psoriasis44,45

• -asmn (Ilumya®) • Dosing information • Inductions: 100 mg SC at weeks 0 and 4 • Maintenance: 100 mg SC every 12 weeks • Safety • Angioedema and urticarial • Efficacy • Tildrakizumab > etanercept in week 12 and 28 PASI 75 response • Long-term studies showing sustained results into 2 years – 80% PASI 75 Case 2 – Psoriasis

AH is a 34 year-old female with a 10 year history of plaque psoriasis. Her condition is extensive, effecting areas of her face, scalp, and palms. She has tried multiple topical treatments and suffers from depression and anxiety due to disease persistence. Other past treatments include etanercept, adalimumab, and ustekinumab. AH’s dermatologist would like to switch her to another medication to better control her condition.

What is an appropriate treatment option? A. Certolizumab B. Brodalumab C. Sarilumab D. Tildrakizumab E. Secukinumab Case 2 – Psoriasis (cont.)

A few days later you receive the following prescription for AH

Secukinumab (Cosentyx) 150 mg/mL pen device QTY: 1 box (2 pens) SIG: Inject 300 mg (2 pens) subcutaneously every 4 weeks

What clinical intervention should be made to the prescriber? Inflammatory Bowel Disease Epidemiology – Inflammatory Bowel Disease48,49

• Affects over 1.6 million adults in the United States • Ulcerative colitis – 900,000 • More common in males • Typically diagnosed in mid-30s • Crohn’s disease – 780,000 • Males and females equally • Develops between 15 to 35 years old • Disease burdens • Over 100,000 hospitalizations each year • 119,000 cases of disability each year • Surgery • CD – 70% of patients with a 30% recurrence rate • UC – 33% of patients Pathogenesis49,50

• Inappropriate immune response in GI tract • Impaired epithelial barrier function • Infiltration of gut microbes and foreign invaders • Triggers immune cell and cytokine accumulation • Inflammation of the intestinal lining • Failure of regulatory T cells to control immune response • Chronic inflammatory state Current Drug Therapy – Crohn’s Disease51

Mild Moderate to severe • Induction • Induction • Budesonide ± thiopurine • Steroids + thiopurine • Steroid taper ± thiopurine • TNFα-inhibitors ± thiopurine • Maintenance • Maintenance • Observation • Thiopurine • Budesonide • TNFα-inhibitors ± thiopurine • Immunosuppressive therapy Current Drug Therapy – Ulcerative Colitis52

Mild to moderate Severe • Induction • Induction • Oral and/or rectal 5-ASA • Oral steroid + thiopurine • Oral budesonide or prednisone • TNFα-inhibitors ± thiopurine and/or rectal steroids • • Maintenance • Maintenance • Oral and/or rectal 5-ASA • Thiopurine + steroid taper • Taper steroids • TNFα-inhibitors ± thiopurine • Vedolizumab IL-23/12 – Crohn’s Disease53,54

• Ustekinumab (Stelara®) • Dosing information • Induction: weight based IV infusion at week 0 • Maintenance: 90 mg SC every 8 weeks, starting 8 weeks after loading dose • Safety • RPLS and non-infectious pneumonia • Serious infections – 0.5 to 2.8% (induction) and 2.3 to 5.3% (maintenance) • Efficacy • Ustekinumab > placebo in induction and response rates at 6 weeks • UNITI-1 – non-responsive to TNFα-inhibitors • UNITI-2 – non-responsive to conventional therapies • Ustekinumab > placebo in maintenance of remission at 44 weeks JAK – Ulcerative Colitis55

• Tofacitinib (Xeljanz®) • Dosing information • 10 mg PO twice daily for at least 8 weeks, then 5 or 10 mg PO twice daily • Safety • Malignancies • Serious infections – 0.5 to 1.3% of patients • Efficacy • Tofacitinib > placebo in induction and response rates at 8 weeks • Tofacitinib > placebo in maintenance of remission at 12 months • Initial remission in OCTACVE 1 or 2 (induction) • 84.4% maintenance after 12 months Pharmacist Management Treatment Considerations

• Goals of therapy • Achievement of remission and minimization of adverse events • Maintenance and prevention of flares • Drug selection • Treatment history • Route of administration • Monotherapy or combination • Potential serious side effects • Increased risk of infections and/or malignancies • Hepatitis B reactivation • Serious allergic reactions Specialty Pharmacy56

Coordination of Care • Aims to improve patient outcomes and decrease healthcare costs • Meet the needs of patients, providers, payers, manufacturers • Providing optimal patient care services • Proactive outreaches for refill management and delivery • Adherence programs • Disease state and drug monitoring, education, and counseling • Benefits investigations and financial assistance • Provider communication Specialty Pharmacy57-59

Patient management – Inflammatory Conditions • Prior to starting therapy • Initial TB and Hepatitis B testing • Counseling on the risk of infection and warning signs • Injection counseling and storage requirements • Prospective dose reviews • During therapy • Depression screening • Management of flares • Side effect counseling and management • Drug therapy or dose changes Specialty Pharmacy – Patient Impact60-63

• Medication adherence • Outreach programs, side effect management, proactive refills • Therapy continuation • Refill persistence, lower rates of discontinuation • QOL measures • Disease therapy management program improved physical functioning • Medical costs and utilizations • Financial assistance, decreased medical costs, lower ED risk • Medication access • Limited distribution drugs Conclusion

• Rheumatoid arthritis, psoriasis, and inflammatory bowel disease are immune- mediated inflammatory conditions • Complications are common for patients, having a great impact on their quality of life • New drug therapies target specific cytokines and signaling molecules • Superiority over current treatments • Outdated guidelines do not address place in therapy • Reliance on standard practice and insurance regulations • Complicated dosing regimens, proper administration, and side effect profile • Specialty pharmacists play a key role in patient management • Adherence barriers and medication persistence • Management of flares • Cost savings THANK YOU! QUESTIONS? References

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