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DERP Topic Brief: Targeted Immune Modulators for Plaque Psoriasis and Psoriatic Arthritis Update May 2021

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DERP Topic Brief: Targeted Immune Modulators for Plaque Psoriasis and Psoriatic Arthritis Update May 2021 This report is intended only for state employees in states participating in the Drug Effectiveness Review Project (DERP). Do not distribute outside your state Medicaid agency and public agency partners. DERP Topic Brief: Targeted Immune Modulators for Plaque Psoriasis and Psoriatic Arthritis Update May 2021 Table of Contents Objectives .......................................................................................................................................................... 1 Previous Report ................................................................................................................................................ 1 Background and Context ................................................................................................................................ 1 PICOS ................................................................................................................................................................. 3 Key Questions .................................................................................................................................................. 4 Methods ............................................................................................................................................................. 4 Literature Search .......................................................................................................................................... 4 Study Selection ............................................................................................................................................. 4 Findings .............................................................................................................................................................. 4 Clinical Evidence .......................................................................................................................................... 4 Ongoing Studies ........................................................................................................................................... 7 Summary .......................................................................................................................................................... 11 References ....................................................................................................................................................... 12 Objectives The objectives of this topic brief are to (1) identify randomized controlled trials (RCTs) and nonrandomized studies that assess the effectiveness and harms of targeted immune modulators (TIMs) for the treatment of plaque psoriasis and psoriatic arthritis; and (2) indicate the number and nature of eligible upcoming RCTs and nonrandomized studies for TIMs for the treatment of plaque psoriasis and psoriatic arthritis. The research presented in this report is meant only to help participating organizations make topic selection decisions. Comprehensive review, quality assessment, and synthesis of evidence from the studies presented here will follow only if the participating organizations select this topic. Previous Report Kahwati L, Giger K, Ali R, Gartlehner G. Targeted immune modulators: plaque psoriasis and psoriatic arthritis. Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University; 2020.1 Background and Context Plaque psoriasis is a chronic inflammatory disease characterized by scaling lesions that affect the skin, scalp, and joints.2,3 The severity of plaque psoriasis is usually classified by the percentage of body surface area involved.4,5 Psoriatic arthritis is a chronic inflammatory arthritis that, in most cases, follows the onset of psoriasis; symptoms include pain and stiffness in the affected joints as well as tenderness, swelling, and sometimes loss of range of motion.6 Diagnosis is made on a clinical basis and by ruling out other types of arthritis. The precise etiology of psoriasis and psoriatic arthritis is not completely understood, but likely involves genetic, immunological, and environmental factors.5,7 TIMs are a group of medications used to treat plaque psoriasis and psoriatic arthritis by selectively blocking mechanisms involved in the inflammatory and immune response.6,7 These are often defined by the mode of action and classified into 3 categories—T-cell modulating agents, tumor necrosis factor-alpha (TNF-α) inhibitors, and interleukin (IL)-inhibitors—though other mechanisms now exist.8,9 The US Food and Drug Administration (FDA) approved the first TIM in 1998, and a variety of additional agents, including biosimilars, have since been approved for plaque psoriasis and psoriatic arthritis. At present, some TIMs are approved only for plaque psoriasis or only for psoriatic arthritis, while some are approved for both indications (Table 1).10 State Medicaid program administrators are considering an updated review of the evidence of the effectiveness and harms of TIMs for plaque psoriasis and psoriatic arthritis to aid in managing this class of drugs. The previous review on this topic was completed in March 2020.1 Table 1. FDA Approval Status of Various TIM Agents for Psoriasis and Psoriatic Arthritis Generic Name Trade Name Mechanism Route Approved Populationa Abatacept Orencia Selective T-cell IV or SC Psoriatic arthritis costimulation modulator Adalimumab Humira TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis 1 Generic Name Trade Name Mechanism Route Approved Populationa Adalimumab-adaz Hyrimoz TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Adalimumab-adbm Cyltezo TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Adalimumab-atto Amjevita TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Apremilast Otezla PDE4 inhibitor PO Plaque psoriasis Psoriatic arthritis Brodalumab Siliq IL-17RA inhibitor SC Plaque psoriasis Certolizumab pegol Cimzia TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Etanercept Enbrel TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Etanercept-szzs Erelzi TNF-α inhibitor SC Plaque psoriasis Psoriatic arthritis Golimumab Simponi/ TNF-α inhibitor SC Psoriatic arthritis Simponi ARIA Guselkumab Tremfya IL-23 inhibitor SC Plaque psoriasis Psoriatic arthritis Infliximab Remicade TNF-α inhibitor IV Plaque psoriasis Psoriatic arthritis Infliximab-abda Renflexis TNF-α inhibitor IV Plaque psoriasis Psoriatic arthritis Infliximab-dyyb Inflectra TNF-α inhibitor IV Plaque psoriasis Psoriatic arthritis Infliximab-qbtx Ixifi TNF-α inhibitor IV Plaque psoriasis Psoriatic arthritis Ixekizumab Taltz IL-17A inhibitor SC Plaque psoriasis Psoriatic arthritis Risankizumab Skyrizi IL-23 inhibitor SC Plaque psoriasis Secukinumab Cosentyx IL-17A inhibitor SC Plaque psoriasis Psoriatic arthritis Tildrakizumab Ilumya IL-23 inhibitor SC Plaque psoriasis Tofacitinib Xeljanz JAK inhibitor PO Psoriatic arthritis Xeljanz XR Upadacitinib Rinvoq JAK inhibitor PO Rheumatoid arthritisb Ustekinumab Stelara IL-12/23 p40 inhibitor Initial dose Plaque psoriasis IV then SC Psoriatic arthritis Pipeline Drugs Bimekizumab None IL-17A and IL-17F IV Not yet approved inhibitor BMS-986165 None TYK2 inhibitor PO Not yet approved Mirikizumab None IL-23 inhibitor SC Not yet approved 2 Generic Name Trade Name Mechanism Route Approved Populationa Remtolumab None Dual TNF-α/IL-17 SC Not yet approved inhibitor Notes. a Details of approved indications for each drug can be found in the full prescribing information. Some drugs may be approved for indications other than psoriasis or psoriatic arthritis. b Approved for rheumatoid arthritis and is currently being studied for use in psoriatic arthritis. Abbreviations. IL: interleukin; IV: intravenous; JAK: Janus kinase; PDE4: phosphodiesterase 4; PO: per os (oral); RA: receptor A; SC: subcutaneous; TIM: targeted immune modulator; TNF-α: tumor necrosis factor alpha; TYK2: tyrosine kinase 2; XR: extended release. PICOS Population • Adult outpatients with plaque psoriasis • Adult outpatients with psoriatic arthritis Interventions Table 1 presents TIMs and respective biosimilars that have been approved by the FDA for the treatment of plaque psoriasis or psoriatic arthritis and select pipeline drugs likely to be approved in the near future. Comparators • FDA-approved drugs: Another listed intervention (head-to-head comparison) • Pipeline drugs: Another listed intervention, standard of care, or placebo Outcomes Efficacy and Effectiveness Outcomes • Quality of life • Functional capacity • Productivity, ability to sustain employment • Clinical improvement • Disease remission • Pain • Reduction in the number of swollen or tender joints • Reduction in disease-related hospitalizations • Reduction in disease-specific mortality • Rebound/flare • Joint destruction • Steroid withdrawal Harm Outcomes • Overall adverse events (AEs) • Withdrawals due to AEs • Serious AEs • Specific AEs (e.g., lymphoma, all malignancies, serious infectious diseases, herpes zoster, opportunistic infections, congestive heart failure) • Mortality 3 Study Designs • RCTs with ≥ 12-week study duration • Retrospective and prospective cohort studies comparing an intervention type with another for outcomes on harms o ≥ 12 weeks study duration o Minimum total sample size of 1,000 Key Questions KQ1. What is the comparative effectiveness of TIMs to treat plaque psoriasis and psoriatic arthritis? KQ2. What are the comparative harms of TIMs to treat plaque psoriasis and psoriatic arthritis? KQ3. Do the included drugs differ in effectiveness or harms in the following
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