Janus Kinase Inhibitors and Biosimilars for Rheumatoid Arthritis: Effectiveness and Value ©Institute for Clinical and Economic Review, 2020 Janus Kinase Inhibitors and Biosimilars for Rheumatoid Arthritis: Effectiveness and Value Final Evidence Report and Meeting Summary January 9, 2020 Prepared for ©Institute for Clinical and Economic Review, 2020 Page i Final Evidence Report: JAK Inhibitors and Biosimilars for RA None of the above authors disclosed any conflicts of interest. DATE (...) OF PUBLICATION: January 9, 2020 How to cite this document: Tice J, Kumar V, Chapman R, Walsh J, Herron-Smith S, Cianciolo L, Bradt P, Pearson S. Janus Kinase Inhibitors and Biosimilars for Rheumatoid Arthritis. Institute for Clinical and Economic Review, January 9, 2020. https://icer-review.org/material/ra-update-evidence- report/. Jeffrey A. Tice served as the lead author for the report, led the systematic review and authorship of the comparative clinical effectiveness section, and wrote the background

Upadacitinib (Rinvoq) - Rheumatoid arthritis Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Classified as public by the European Medicines Agency EMA/582949/2019 EMEA/H/C/004760 (...) Rinvoq (upadacitinib) An overview of Rinvoq and why it is authorised in the EU What is Rinvoq and what is it used for? Rinvoq is a medicine for treating adults with rheumatoid arthritis, a disease that causes inflammation of the joints. Rinvoq is used for moderate or severe rheumatoid arthritis that cannot be controlled well enough with disease-modifying anti-rheumatic medicines or if the patient cannot take these medicines. It can be used on its own or with methotrexate, another medicine

Overall infection risk in rheumatoid arthritis during treatment with abatacept, rituximab and tocilizumab; an observational cohort study Overall Infection Risk in Rheumatoid Arthritis During Treatment With Abatacept, Rituximab and Tocilizumab; An Observational Cohort Study - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Welcome to the new PubMed. For legacy PubMed go to . Clipboard, Search History, and several other (...) characters Choose a collection: Unable to load your collection due to an error Add Cancel Add to My Bibliography My Bibliography Unable to load your delegates due to an error Add Cancel Actions Cite Share Permalink Copy Page navigation Rheumatology (Oxford) Actions 2019 Nov 25 [Online ahead of print] Overall Infection Risk in Rheumatoid Arthritis During Treatment With Abatacept, Rituximab and Tocilizumab; An Observational Cohort Study , , , , , , , Affiliations Expand Affiliations 1 DANBIO and Copenhagen

A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis 3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease

A meta-analysis of biologic therapies on risk of new or recurrent cancer in patients with rheumatoid arthritis and a prior malignancy To explore the risk of new and recurrent cancer in adult RA patients with prior malignancy and subsequently exposed to biologic therapies.Separate searches were performed of PubMed, EMBASE and Cochrane Library and conference proceedings for observational studies reporting cancer incidence or recurrence in patients with RA and prior malignancy treated

Trends in all-cause and cardiovascular mortality in patients with incident rheumatoid arthritis: a 20-year follow-up matched case-cohort study To examine all-cause and cardiovascular disease (CVD) mortality in consecutive cohorts of patients with incident RA, compared with population comparators.The Oslo RA register inclusion criteria were diagnosis of RA (1987 ACR criteria) and residency in Oslo. Patients with disease onset 1994-2008 and 10 matched comparators for each case were linked

Comparative safety of biologic versus conventional synthetic DMARDs in rheumatoid arthritis with COPD: a real-world population study Abatacept, a biologic DMARD, was associated with respiratory adverse events in a small subgroup of RA patients with chronic obstructive pulmonary disease (COPD) in a trial. Whether this potential risk is specific to abatacept or extends to all biologics and targeted synthetic DMARDs (tsDMARDs) is unclear. We assessed the risk of adverse respiratory events

Remission vs low disease activity: function, quality of life and structural outcomes in the Early Rheumatoid Arthritis Study and Network To examine associations between function, quality of life and structural outcomes in patients achieving remission vs low disease activity in early RA.Demographic, clinical and radiographic variables were collected at baseline and then annually from the Early Rheumatoid Arthritis Study (ERAS) and Early Rheumatoid Arthritis Network (ERAN) inception cohorts

Upadacitinib (Rinvoq) - rheumatoid arthritis CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 211675Orig1s000 CLINICAL REVIEW(S) Clinical Review Keith M Hull, MD, PhD NDA 211675 RINVOQ (upadacitinib) CLINICAL REVIEW Application Type NDA Application Number(s) 211675 Priority or Standard Priority Submit Date(s) 18 Dec 2018 Received Date(s) 18 Dec 2018 PDUFA Goal Date 18 Aug 2019 Division/Office Division of Pulmonary, Allergy and Rheumatology Products Reviewer Name(s) Keith M Hull, MD (...) , PhD Review Completion Date 17 May 2019 Established/Proper Name Upadacitinib (Proposed) Trade Name RINVOQ Applicant AbbVie Inc Dosage Form(s) 15 mg extended release tablets Applicant Proposed Dosing Regimen(s) 15 mg orally administered QD Applicant Proposed Indication(s)/Population(s) Recommendation on Regulatory Action Approval Recommended Indication(s)/Population(s) (if applicable) Treatment of adults with moderately to severely active rheumatoid arthritis who had an inadequate response

Triple Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs for the Management of Rheumatoid Arthritis Triple Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs for the Management of Rheumatoid Arthritis | CADTH.ca Find the information you need Triple Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs for the Management of Rheumatoid Arthritis Triple Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs for the Management of Rheumatoid Arthritis Last (...) updated: March 26, 2019 Project Number: RC1087-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the cost-effectiveness of triple conventional synthetic disease-modifying anti-rheumatic drugs compared with other pharmacologic options for the management of rheumatoid arthritis? Key Message Two relevant publications comprising cost-effectiveness analyses were identified; one involved patients with rheumatoid arthritis (RA) that could

Upadacitinib (TBC) - Arthritis, Rheumatoid upadacitinib | CADTH.ca Find the information you need upadacitinib upadacitinib Last Updated: October 4, 2019 Result type: Reports Project Number: SR0614-000 Product Line: Generic Name: upadacitinib Brand Name: TBC Manufacturer: AbbVie Indications: Arthritis, Rheumatoid Manufacturer Requested Reimbursement Criteria 1 : Upadacitinib to be listed for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded (...) recommendation, if applicable. Key Milestones 2 Call for patient input posted May 31, 2019 Patient group input closed July 22, 2019 Clarification: - Patient input submission received from the Arthritis Consumer Experts, Canadian Arthritis Patient Alliance (CAPA) & The Arthritis Society Patient input summary sent for review to patient input groups July 30, 2019 Patient group comments on input summary closed August 07, 2019 Clarification: - Patient input summary feedback received Submission received July 04

Olumiant - baricitinib - Arthritis, Rheumatoid baricitinib | CADTH.ca Find the information you need baricitinib baricitinib Last Updated: September 12, 2019 Result type: Reports Project Number: SR0597-000 Product Line: Generic Name: baricitinib Brand Name: Olumiant Manufacturer: Eli Lilly Canada Inc. Indications: Arthritis, Rheumatoid Manufacturer Requested Reimbursement Criteria 1 : In combination with methotrexate (MTX), indicated for reducing the signs and symptoms of moderate to severe (...) rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs).Olumiant may be used as monotherapy in cases of intolerance to MTX. Submission Type: New Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: August 2, 2019 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do

Anti-interleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trial The inflammatory contribution to type 2 diabetes (T2D) has suggested new therapeutic targets using biologic drugs designed for rheumatoid arthritis (RA). On this basis, we aimed at investigating whether interleukin-1 (IL-1) inhibition with anakinra, a recombinant human IL-1 receptor antagonist, could improve both glycaemic and inflammatory (...) haemoglobin (HbA1c%) (EudraCT: 2012-005370-62 ClinicalTrial.gov: NCT02236481). In total, 41 participants with RA and T2D were randomised, and 39 eligible participants were treated (age 62.72 ± 9.97 years, 74.4% female sex). The majority of participants had seropositive RA disease (rheumatoid factor and/or anticyclic citrullinated peptide antibody [ACPA] 70.2%) with active disease (Disease Activity Score-28 [DAS28]: 5.54 ± 1.03; C-reactive protein 11.84 ± 9.67 mg/L, respectively). All participants had T2D

Benefit assessment of biotechnologically produced drugs for the treatment of rheumatoid arthritis 1 Translation of Chapters 1 to 6 of the final report A16-70 Biotechnologisch hergestellte Wirkstoffe bei rheumatoider Arthritis (Version 1.0; Status: 23 July 2019 [German original], 16 September 2019 [English translation]). Please note: This document is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally (...) binding. Extract IQWiG Reports – Commission No. A16-70 Biologics for rheumatoid arthritis 1 Extract of final report A16-70 Version 1.0 Biologics for rheumatoid arthritis 23 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Biologics for rheumatoid arthritis Commissioning agency: Federal Joint Committee Commission awarded on: 24 November 2016 Internal Commission No.: A16-70 Address

Rituximab as Maintenance Treatment in Rheumatoid Arthritis Rituximab as Maintenance Treatment in Rheumatoid Arthritis | CADTH.ca Find the information you need Rituximab as Maintenance Treatment in Rheumatoid Arthritis Rituximab as Maintenance Treatment in Rheumatoid Arthritis Last updated: March 29, 2019 Project Number: HO0002-000 - HE0021-000 Product Line: Technology Review Result type: Report This project reviewed the evidence on the administration of repeated courses of rituximab

Leflunomide for the Management of Rheumatoid Arthritis: Comparative Clinical Effectiveness Leflunomide for the Management of Rheumatoid Arthritis: Comparative Clinical Effectiveness | CADTH.ca Find the information you need Leflunomide for the Management of Rheumatoid Arthritis: Comparative Clinical Effectiveness Leflunomide for the Management of Rheumatoid Arthritis: Comparative Clinical Effectiveness Last updated: January 15, 2019 Project Number: RA0999-000 Product Line: Research Type: Drug (...) Report Type: Reference List Result type: Report Question What is the clinical effectiveness of leflunomide compared with other disease modifying antirheumatic drugs for the management of rheumatoid arthritis? Key Message One randomized controlled trial was identified regarding the clinical effectiveness of leflunomide for rheumatoid arthritis management. Files Rapid Response Reference List Published : January 15, 2019 Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our

Tai Chi for rheumatoid arthritis. Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory, autoimmune disease that results in joint deformity and immobility of the musculoskeletal system. The major goals of treatment are to relieve pain, reduce inflammation, slow down or stop joint damage, prevent disability, and preserve or improve the person's sense of well-being and ability to function. Tai Chi, interchangeably known as Tai Chi Chuan, is an ancient Chinese health-promoting martial art (...) form that has been recognized in China as an effective arthritis therapy for centuries. This is an update of a review published in 2004.To assess the benefits and harms of Tai Chi as a treatment for people with rheumatoid arthritis (RA).We updated the search of CENTRAL, MEDLINE, Embase, and clinical trial registries from 2002 to September 2018.We selected randomized controlled trials and controlled clinical trials examining the benefits (ACR improvement criteria or pain, disease progression

Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial To evaluate the efficacy, including capacity for inhibition of radiographic progression, and safety of upadacitinib, a JAK1-selective inhibitor, as compared to placebo or adalimumab in patients with rheumatoid arthritis (RA) who have experienced an inadequate response to methotrexate (MTX).In total, 1,629 RA

Efficacy of Atlantoaxial Joint Glucocorticoid Injection in Patients with Rheumatoid Arthritis: A Randomized Trial The atlantoaxial joint (AAJ) plays a pivotal role in the cervical spine motion. Unfortunately, it is the most common cervical spine joint that is affected in patients with rheumatoid arthritis. Inflammation of the AAJ results in neck disability, nerve root compression, and finally spinal cord compression.We aim to evaluate the efficacy of intraarticular triamcinolone injection (...) of the AAJ on neck pain and disability.A prospective randomized, controlled clinical trial.An interventional pain unit in a tertiary center at a university hospital in Egypt.Sixty patients with rheumatoid arthritis complaining of AAJ arthritis were randomized into 2 groups. Group AAJI (n = 30) received AAJ injection with 1.0 mL of a mixture of 0.5 mL of bupivacaine 0.5% and 0.5 mL of 20 mg of triamcinolone, in addition to oral placebo tablets (2 tablets every 8 hours for one week). Group SS (n = 30

A Multicenter, Randomized, Placebo-Controlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis Rheumatoid arthritis (RA) is associated with increased cardiovascular event (CVE) risk. The impact of statins in RA is not established. We assessed whether atorvastatin is superior to placebo for the primary prevention of CVEs in RA patients.A randomized, double-blind, placebo-controlled trial was designed to detect a 32% CVE risk (...) %). The rates of adverse events in the atorvastatin group (n = 298 [19.8%]) and placebo group (n = 292 [19.5%]) were similar.Atorvastatin 40 mg daily is safe and results in a significantly greater reduction of LDL cholesterol level than placebo in patients with RA. The 34% CVE risk reduction is consistent with the Cholesterol Treatment Trialists' Collaboration meta-analysis of statin effects in other populations.© 2019, The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf