DOCSLIB.ORG

Re-Treatment with Abatacept Plus Methotrexate for Disease Flare After Complete Treatment Withdrawal in Patients with Early Rheum

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Re-Treatment with Abatacept Plus Methotrexate for Disease Flare After Complete Treatment Withdrawal in Patients with Early Rheum Rheumatoid arthritis RMD Open: first published as 10.1136/rmdopen-2018-000840 on 8 February 2019. Downloaded from ORIGINAL ARTICLE Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study Paul Emery,1,2 Gerd R Burmester,3 Vivian P Bykerk,4 Bernard G Combe,5 Daniel E Furst,6 Michael A Maldonado,7 Tom WJ Huizinga8 To cite: Emery P, Burmester GR, ABSTRACT Bykerk VP, et al. Re- Objectives To complete reporting of outcomes after total Key messages treatment with abatacept withdrawal of all rheumatoid arthritis (RA) therapy and re- plus methotrexate for disease treatment after flare inA ssessing Very Early Rheumatoid What is already known about this subject? flare after complete treatment arthritis Treatment study (NCT01142726). ► Abatacept in combination with methotrexate induc- withdrawal in patients with es remission more often than methotrexate alone early rheumatoid arthritis: Methods Patients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus after 12 months of treatment, with a greater propor- 2-year results from the tion of patients with rheumatoid arthritis (RA) main- AVERT study. methotrexate, or abatacept or methotrexate monotherapy. RMD Open taining remission over 6 months following treatment 2019;5:e000840. doi:10.1136/ At month 12, patients with Disease Activity Score (DAS)28 rmdopen-2018-000840 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawal. withdrawn and were observed for ≤12 months or until What does this study add? flare.A fter ≥3 months’ withdrawal, patients with protocol- ► Prepublication history and ► These final results of theA ssessing Very Early additional material for this defined RA flare received open-label abatacept plus Rheumatoid arthritis Treatment (AVERT) study paper are available in online. methotrexate for 6 months (re-treatment). demonstrate that, after receiving only 12 months Results Proportion of patients in DAS28-CRP–defined http://rmdopen.bmj.com/ To view these files, please visit of disease-modifying antirheumatic drug therapy remission remained numerically higher in original the journal online (http:// dx. doi. before withdrawal of all RA treatments, the majority org/ 10. 1136/ rmdopen- 2018- abatacept plus methotrexate and abatacept arms versus of patients will experience a flare within 6 months 000840). methotrexate arm up to day 253 of withdrawal. At the of treatment withdrawal and very few will sustain end of the withdrawal period, few patients remained in major responses for 1 year. Received 11 October 2018 remission across all arms: 9/73 (12.3%), 7/50 (14.0%) The study provides the most complete data on Revised 6 December 2018 and 6/53 (11.3%), respectively. For patients entering re- ► re-treatment with abatacept plus methotrexate Accepted 8 January 2019 treatment, after 6 months’ re-treatment, 95/124 (76.6%) showing that this combination can restore remission and 78/124 (62.9%) patients achieved DAS28-CRP or low disease activity in many patients who experi- <3.2 and <2.6, respectively; mean changes in DAS28-CRP on September 30, 2021 by guest. Protected copyright. and Health Assessment Questionnaire–Disability Index enced a flare after treatment withdrawal, with good scores from re-treatment baseline were –2.87 and 0.76, tolerability. respectively. Re-treatment was well tolerated; exposure- How might this impact on clinical practice? adjusted infection rates per 100 patient-years were lower ► This is the first study to examine the effects of com- with abatacept plus methotrexate during withdrawal (7.2) plete and rapid removal of all RA therapy, creating and re-treatment (17.2) versus initial treatment periods of data that will inform future efforts to develop off- months 0–6 (116.6) and 6–12 (64.6). drug remission strategies. Conclusions Most patients flared within 6 months of © Author(s) (or their therapy withdrawal and few sustained major responses for employer(s)) 2019. Re-use 1 year. Re-treatment with abatacept plus methotrexate was permitted under CC BY-NC. No effective and well tolerated in this controlled setting. achieving remission within this window, commercial re-use. See rights and permissions. Published tapering or withdrawal of treatment may offer 3–5 by BMJ. certain advantages if remission is sustained. For numbered affiliations see INTRODUCTION In order to develop biologic-free or even 3 end of article. In early rheumatoid arthritis (RA), a window drug-free remission strategies, we must Correspondence to may exist during which intensive treatment better understand the ability of current ther- Dr Paul Emery; can alter the disease course, leading to apies to sustain long-term off-drug remission, p. emery@ leeds. ac. uk improved long-term outcomes.1 2 For patients including the management of disease flares. Emery P, et al. RMD Open 2019;5:e000840. doi:10.1136/rmdopen-2018-000840 1 RMD Open RMD Open: first published as 10.1136/rmdopen-2018-000840 on 8 February 2019. Downloaded from Co-primary: Co-primary: DAS-defined remission DAS-defined remission Co-primary DAS28-CRP Ͻ2.6) at month 12 endpoints: at month 12 AND month 18 Early Abatacept + MTX RA If Ͻ3.2 Randomisation* Abatacept + placebo withdraw ALL study meds DAS28-CRP DAS28-CRP MTX Re-exposure period: If flare or worsening symptoms If у3.2 during months 15–24 then 6 months’ then D/C open-label abatacept + MTX Period: Treatment Withdrawal 012151824 Months Figure 1 Study design. *Randomisation stratified by corticosteroid use at baseline. DAS28-CRP, Disease Activity Score 28-C reactive protein; D/C, discontinuation; MTX, methotrexate; RA, rheumatoid arthritis. Reprinted from Emery P, et al. Ann Rheum Dis 2015;74:19-26, which is published under Creative Commons license CC BY-NC 4.0 (https://creativecommons.org/licenses/ by-nc/4.0/legalcode). In the Assessing Very Early Rheumatoid arthritis Treat- treatments were stopped—abatacept immediately, and ment (AVERT) study, treatment-naïve patients with early methotrexate and corticosteroids tapered over 1 month. RA were randomised to either subcutaneous abatacept Patients with protocol-defined RA flare after month 15 plus methotrexate, subcutaneous abatacept or meth- could receive open-label subcutaneous abatacept plus otrexate monotherapy for 1 year followed by complete methotrexate in a 6-month re-treatment period. RA flare withdrawal of all RA-specific therapeutic agents, including was defined as ≥2 of the following after the first 3 months http://rmdopen.bmj.com/ corticosteroids, and then monitored for flares before of the withdrawal period: doubling of tender and swollen re-treating with abatacept plus methotrexate. As previ- joint counts, increase in DAS28-CRP ≥1.2 (both from ously reported, it demonstrated the benefits, including month 12) or investigator’s judgement of RA flare. Abata- MRI improvements, of abatacept plus methotrexate versus cept was administered at 125 mg/week and methotrexate methotrexate alone in inducing remission at 12 months titrated to 10–20 mg/week. and maintaining remission over the first 6 months after Eligibility criteria included age ≥18 years, active clinical 6 7 withdrawal of all RA treatment. This report completes synovitis of ≥2 joints for ≥8 weeks, persistent RA symptoms the description of the efficacy and safety outcomes over for ≤2 years, DAS28-CRP ≥3.2, anticyclic citrullinated on September 30, 2021 by guest. Protected copyright. the full 12-month treatment withdrawal period and the peptide 2 (anti-CCP2) antibody positivity and metho- benefits of 6 months of re-treatment after an RA flare. trexate naïve/minimum exposure. Patients receiving It also explores which clinical characteristics were asso- oral corticosteroids had to be on a stable dose (≤10 mg/ ciated with flare or with regaining disease control after day) at baseline and maintain that dose until month 12; re-treatment. randomisation was stratified by baseline corticosteroid use (yes/no). METHODS Study design and patient population Assessments and statistical analyses Methodology of the phase IIIb AVERT study Proportions of patients in the withdrawal period with (NCT01142726) was published previously (figure 1).6 remission, defined as DAS28-CRP <2.6, Clinical Disease In the initial 12-month, double-blind treatment period, Activity Index (CDAI) ≤2.8, Simplified Disease Activity patients were randomised (1:1:1) to subcutaneous abata- Index (SDAI) ≤3.3 and Boolean criteria,8 and with low cept plus oral methotrexate, abatacept monotherapy plus disease activity (LDA) defined as DAS28-CRP <3.2, were oral placebo, or methotrexate monotherapy plus subcu- described over time. For patients entering withdrawal, taneous placebo. After 12 months, patients with Disease time to first RA flare during withdrawal and predictors Activity Score (DAS)28 C reactive protein (CRP) <3.2 of time to flare were analysed using a Cox proportion- could enter a 12-month withdrawal period and all RA al-hazards model including the following parameters at 2 Emery P, et al. RMD Open 2019;5:e000840. doi:10.1136/rmdopen-2018-000840 Rheumatoid arthritis RMD Open: first published as 10.1136/rmdopen-2018-000840 on 8 February 2019. Downloaded from initial study entry: randomised treatment, DAS28-CRP, (n=146) were studied to determine if any characteristic swollen joint count, Patient Global Assessment of Disease at study entry could predict an earlier flare after treat- Activity (PtGA), corticosteroid use, RA symptom dura- ment withdrawal. Kaplan-Meier curves for time to proto- tion, smoking status and anti-CCP2 antibody status. col-defined first flare during withdrawal showed no clear Summary statistics were generated for the mean change differences between randomisation arms (figure 2). Cox from re-treatment baseline to the end of re-treatment in proportional-hazards model of time to first flare after DAS28-CRP and Health Assessment Questionnaire-Dis- treatment withdrawal using various baseline parameters ability Index (HAQ-DI) scores, and for proportions of identified that only corticosteroid use at baseline was patients with DAS28-CRP remission and LDA at the end associated with a faster time to flare (p=0.0159; table 2).
Load more

Recommended publications
  • Australian Public Assessment Report for Abatacept (Rch)
    Australian Public Assessment Report for Abatacept (rch) Proprietary Product Name: Orencia Sponsor: Bristol-Myers Squibb Australia Pty Ltd June 2011 About the Therapeutic Goods Administration (TGA) · The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. · TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0209462 A1 Bilotti Et Al
    US 20170209462A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0209462 A1 Bilotti et al. (43) Pub. Date: Jul. 27, 2017 (54) BTK INHIBITOR COMBINATIONS FOR Publication Classification TREATING MULTIPLE MYELOMA (51) Int. Cl. (71) Applicant: Pharmacyclics LLC, Sunnyvale, CA A 6LX 3/573 (2006.01) A69/20 (2006.01) (US) A6IR 9/00 (2006.01) (72) Inventors: Elizabeth Bilotti, Sunnyvale, CA (US); A69/48 (2006.01) Thorsten Graef, Los Altos Hills, CA A 6LX 3/59 (2006.01) (US) A63L/454 (2006.01) (52) U.S. Cl. CPC .......... A61 K3I/573 (2013.01); A61K 3 1/519 (21) Appl. No.: 15/252,385 (2013.01); A61 K3I/454 (2013.01); A61 K 9/0053 (2013.01); A61K 9/48 (2013.01); A61 K (22) Filed: Aug. 31, 2016 9/20 (2013.01) (57) ABSTRACT Disclosed herein are pharmaceutical combinations, dosing Related U.S. Application Data regimen, and methods of administering a combination of a (60) Provisional application No. 62/212.518, filed on Aug. BTK inhibitor (e.g., ibrutinib), an immunomodulatory agent, 31, 2015. and a steroid for the treatment of a hematologic malignancy. US 2017/0209462 A1 Jul. 27, 2017 BTK INHIBITOR COMBINATIONS FOR Subject in need thereof comprising administering pomalido TREATING MULTIPLE MYELOMA mide, ibrutinib, and dexamethasone, wherein pomalido mide, ibrutinib, and dexamethasone are administered con CROSS-REFERENCE TO RELATED currently, simulataneously, and/or co-administered. APPLICATION 0008. In some aspects, provided herein is a method of treating a hematologic malignancy in a subject in need 0001. This application claims the benefit of U.S.
    [Show full text]
  • Download (PDF)
    Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Information for the public Published: TBC nice.org.uk What has NICE said? Abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel) and tocilizumab (RoActemra) are recommended as possible treatments for people with polyarticular juvenile idiopathic arthritis. Adalimumab and etanercept are recommended as possible treatments for people with enthesitis- related juvenile idiopathic arthritis. Etanercept is recommended as a possible treatment for people with psoriatic juvenile idiopathic arthritis. What does this mean? If your (or your child's) doctor thinks that abatacept, adalimumab, etanercept or tocilizumab are the right treatment, you (or your child) should be able to have the treatment on the NHS. Abatacept, adalimumab, etanercept and tocilizumab should be available on the NHS within 3 months of the guidance being issued. If you (or your child) are not eligible for treatment as described above, you (or your child) should be able to continue taking abatacept, adalimumab, etanercept or tocilizumab until you and your (or your child's) doctor decide it is the right time to stop. © NICE TBC. All rights reserved. Page 1 of 3 Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Why has NICE said this? NICE looks at how well treatments work in relation to how much they cost compared with other treatments available on the NHS. Abatacept, adalimumab, etanercept and tocilizumab were recommended because the benefits to patients justify their cost. The condition and the treatments Arthritis causes pain and inflammation in joints. Juvenile idiopathic arthritis is a type of arthritis that starts in people younger than 16 years (juvenile).
    [Show full text]
  • COMPARISON of the WHO ATC CLASSIFICATION & Ephmra/Intellus Worldwide ANATOMICAL CLASSIFICATION
    COMPARISON OF THE WHO ATC CLASSIFICATION & EphMRA/Intellus Worldwide ANATOMICAL CLASSIFICATION: VERSION June 2019 2 Comparison of the WHO ATC Classification and EphMRA / Intellus Worldwide Anatomical Classification The following booklet is designed to improve the understanding of the two classification systems. The development of the two systems had previously taken place separately. EphMRA and WHO are now working together to ensure that there is a convergence of the 2 systems rather than a divergence. In order to better understand the two classification systems, we should pay attention to the way in which substances/products are classified. WHO mainly classifies substances according to the therapeutic or pharmaceutical aspects and in one class only (particular formulations or strengths can be given separate codes, e.g. clonidine in C02A as antihypertensive agent, N02C as anti-migraine product and S01E as ophthalmic product). EphMRA classifies products, mainly according to their indications and use. Therefore, it is possible to find the same compound in several classes, depending on the product, e.g., NAPROXEN tablets can be classified in M1A (antirheumatic), N2B (analgesic) and G2C if indicated for gynaecological conditions only. The purposes of classification are also different: The main purpose of the WHO classification is for international drug utilisation research and for adverse drug reaction monitoring. This classification is recommended by the WHO for use in international drug utilisation research. The EphMRA/Intellus Worldwide classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies. Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems.
    [Show full text]
  • Cimzia (Certolizumab Pegol) AHM
    Cimzia (Certolizumab Pegol) AHM Clinical Indications • Cimzia (Certolizumab Pegol) is considered medically necessary for adult members 18 years of age or older with moderately-to-severely active disease when ALL of the following conditions are met o Moderately-to-severely active Crohn's disease as manifested by 1 or more of the following . Diarrhea . Abdominal pain . Bleeding . Weight loss . Perianal disease . Internal fistulae . Intestinal obstruction . Megacolon . Extra-intestinal manifestations: arthritis or spondylitis o Crohn's disease has remained active despite treatment with 1 or more of the following . Corticosteroids . 6-mercaptopurine/azathioprine • Certollizumab pegol (see note) is considered medically necessary for persons with active psoriatic arthritis who meet criteria in Psoriasis and Psoriatic Arthritis: Biological Therapies. • Cimzia, (Certolizumab Pegol), alone or in combination with methotrexate (MTX), is considered medically necessary for the treatment of adult members 18 years of age or older with moderately-to-severely active rheumatoid arthritis (RA). • Cimzia (Certolizumab pegol is considered medically necessary for reducing signs and symptoms of members with active ankylosing spondylitis who have an inadequate response to 2 or more NSAIDs. • Cimzia (Certolizumab Pegol) is considered investigational for all other indications (e.g.,ocular inflammation/uveitis; not an all-inclusive list) because its effectiveness for indications other than the ones listed above has not been established. Notes • There are several brands of targeted immune modulators on the market. There is a lack of reliable evidence that any one brand of targeted immune modulator is superior to other brands for medically necessary indications. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Simponi (golimumab), Simponi Aria (golimumab intravneous), and Stelara (ustekinumab) brands of targeted immune modulators ("least cost brands of targeted immune modulators") are less costly to the plan.
    [Show full text]
  • NULOJIX, Through the Centralised Procedure Falling Within the Article 3(1) and Point 1 of Annex of Regulation (EC) No 726/2004
    Assessment report NULOJIX International Nonproprietary Name: Belatacept Procedure No. EMEA/H/C/2098 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 4 1.1. Submission of the dossier.................................................................................... 4 1.2. Steps taken for the assessment of the product ....................................................... 4 2. Scientific discussion ................................................................................ 5 2.1. Introduction ...................................................................................................... 5 2.2. Quality aspects .................................................................................................. 7 2.3. Non-clinical aspects .......................................................................................... 12 Methods of analysis ................................................................................................ 17 Absorption............................................................................................................. 18 Distribution...........................................................................................................
    [Show full text]
  • CIRCULAR 73 of 2015: Entry and Verification (E&V) Criteria for Identifying Beneficiaries with Risk Factors in Medical Scheme
    CIRCULAR Reference: E&V version 9.1 Contact person: Carrie-Anne Cairncross Tel: 012 431 0412 Fax: 086 687 3979 E-mail: [email protected] Date: 11 December 2015 CIRCULAR 73 OF 2015: Entry and verification (E&V) criteria for identifying beneficiaries with risk factors in medical schemes The Council for Medical schemes (CMS) has published the guidelines for identifying medical scheme beneficiaries with risk factors in accordance with the entry and verification criteria. (http://www.medicalschemes.com/files/ITAP%20Documents/Vers9_1OfEVGdlns20151211.pdf) It is important that medical schemes and administrators take note of the updated version 9.1 and implement all the changes made in the guideline before they extract the data for the 2015 submission. The changes are listed below. 1. Parts 3 and 4, which relate to preparation and submission of data has been amended to reflect the submission of Scheme Risk Measurement (SRM) data via the Healthcare Utilisation Annual Statutory Returns (ASR) System. 2. Changes to clinical entry end verification criteria: 2.1. The provider type was changed from any registered medical practitioner to specialist ophthalmologist (Table 17) 2.2. Glaucoma was added to the list of conditions that need specialist diagnosis as stated in paragraph 5.17 2.3. Rheumatoid Arthritis was removed from paragraph 5.17 2.4. The note on the Rheumatoid Arthritis table i.e. “Where a patient is not using disease modifying anti-rheumatic medicines, the diagnosis must be verified by a specialist physician or rheumatologist” has been updated to state “Where a patient is using disease modifying anti-rheumatic medicines, the diagnosis must be verified by a specialist physician or rheumatologist.” 2.5.
    [Show full text]
  • Active Conventional Treatment and Three Different Biological Treatments in Early Rheumatoid Arthritis
    BMJ: first published as 10.1136/bmj.m4328 on 2 December 2020. Downloaded from RESEARCH Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial Merete Lund Hetland,1,2 Espen A Haavardsholm,3 Anna Rudin,4,5 Dan Nordström,6,7 Michael Nurmohamed,8,9 Bjorn Gudbjornsson,10,11 Jon Lampa,12 Kim Hørslev-Petersen,13,14 Till Uhlig,3,15 Gerdur Grondal,10,11 Mikkel Østergaard,1,2 Marte S Heiberg,3 Jos Twisk,16 Kristina Lend,12 Simon Krabbe,1,2 Lise Hejl Hyldstrup,1,2 Joakim Lindqvist,12 Anna-Karin Hultgård Ekwall,4,5 Kathrine Lederballe Grøn,1 Meliha Kapetanovic,17 Francesca Faustini,12 Riitta Tuompo,6,7 Tove Lorenzen,18 Giovanni Cagnotto,19,20 Eva Baecklund,21 Oliver Hendricks,13 Daisy Vedder,8 Tuulikki Sokka-Isler,22 Tomas Husmark,23 Maud-Kristine Aga Ljoså,24 Eli Brodin,25 Torkell Ellingsen,26 Annika Söderbergh,27 Milad Rizk,28 Åsa Reckner Olsson,29 Per Larsson,30 Line Uhrenholt,31 Søren Andreas Just,32 David John Stevens,33 Trine Bay Laurberg,34 Gunnstein Bakland,35 Inge C Olsen,36 Ronald van Vollenhoven,9,12 on behalf of the NORD-STAR study group For numbered affiliations see ABSTRACT and rheumatoid factor or anti-citrullinated protein end of the article. OBJECTIVE antibody positivity, or increased C reactive protein. Correspondence to: To evaluate and compare benefits and harms of three INTERVENTIONS M L Hetland biological treatments with different modes of action Randomised 1:1:1:1, stratified by country, sex, Copenhagen Center for versus active conventional treatment in patients with Arthritis Research, Center and anti-citrullinated protein antibody status.
    [Show full text]
  • ORENCIA Safely • Administer 125 Mg by Subcutaneous Injection Once Weekly Without an Intravenous and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION Subcutaneous Use for Adult PsA (2.3) These highlights do not include all the information needed to use ORENCIA safely • Administer 125 mg by subcutaneous injection once weekly without an intravenous and effectively. See full prescribing information for ORENCIA. loading dose. ORENCIA (abatacept) for injection, for intravenous use • Patients switching from intravenous use to subcutaneous use, administer first ORENCIA (abatacept) injection, for subcutaneous use subcutaneous dose instead of next scheduled intravenous dose. Initial U.S. Approval: 2005 Preparation and Administration Instructions ------------------------------ RECENT MAJOR CHANGES ------------------------------ • Administer as a 30-minute intravenous infusion (2.4) Warnings and Precautions, Immunosuppression (5.6) 6/2020 • See the Full Prescribing Information for preparation and administration instructions for intravenous infusion and recommendations for subcutaneous use (2.4, 2.5). Prepare -------------------------------INDICATIONS AND USAGE ------------------------------ ORENCIA (abatacept) using only the silicone-free disposable syringe (2.4) ORENCIA is a selective T cell costimulation modulator indicated for the treatment of (1.2, 1.3): • Adult patients with moderately to severely active rheumatoid arthritis (RA) -------------------------- DOSAGE FORMS AND STRENGTHS -------------------------- Intravenous Infusion • Patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) • For injection: 250 mg lyophilized powder in a single-dose vial (may use less than full contents of vial or use more than one vial) (3) • Adult patients with active psoriatic arthritis (PsA) Subcutaneous Use Limitations of Use: • Injection: 50 mg/0.4 mL, 87.5 mg/0.7 mL, 125 mg/mL solution in single-dose prefilled Concomitant use of ORENCIA with other immunosuppressives [e.g., biologic disease- syringes (3) modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended (1.4, 5.1).
    [Show full text]
  • Cost Per Response for Abatacept Versus Adalimumab in Patients with Seropositive, Erosive Early Rheumatoid Arthritis in the US, Germany, Spain, and Canada
    Rheumatology International (2019) 39:1621–1630 Rheumatology https://doi.org/10.1007/s00296-019-04352-2 INTERNATIONAL PUBLIC HEALTH Cost per response for abatacept versus adalimumab in patients with seropositive, erosive early rheumatoid arthritis in the US, Germany, Spain, and Canada Jason Foo1 · Chaienna Morel1 · Martin Bergman2 · Christoph Baerwald3 · José Manuel Rodriguez‑Heredia4 · Alexander Marshall5 · Carlos Polanco‑Sánchez6 · Roelien Postema7 Received: 12 January 2019 / Accepted: 17 June 2019 / Published online: 25 June 2019 © The Author(s) 2019 Abstract Background Efective treatment of rheumatoid arthritis (RA) with biologic DMARDs poses a signifcant economic burden. The AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE RA subjects with background methotrexate) trial was a head-to-head, randomized study comparing abatacept with adalimumab. A post hoc analysis showed improved efcacy for abatacept in patients with versus without seropositive, erosive early RA. Objective The aim of the current study was to evaluate the cost per response (ACR20/50/70/90 and HAQ-DI) and patient in remission (DAS28-CRP, CDAI, and SDAI) for abatacept relative to adalimumab, in patients with seropositive, erosive early RA in the US, Germany, Spain, and Canada. Methods A previously published model was used to compare abatacept and adalimumab in a cohort of 1000 patients over 2 years. Clinical inputs were updated based on two subpopulations from the AMPLE trial. Cohort 1 included patients with early RA (disease duration ≤ 6 months), RF and/or ACPA seropositivity, and > 1 radiographic erosion. Cohort 2 included patients with RA in whom at least one of these criteria was absent. Results For cohort 1, all incremental costs per additional health gain (patient response or patient in remission) favoured abatacept in all countries, except for DAS28-CRP remission in Canada.
    [Show full text]
  • Australian Public Assessment Report for Abatacept (Rch)
    Australian Public Assessment Report for Abatacept (rch) Proprietary Product Name: Orencia Sponsor: Bristol-Myers Squibb Australia Pty Ltd April 2010 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. · TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]
  • Abatacept (Orencia) Reference Number: ERX.SPA.123 Effective Date: 10.01.16 Last Review Date: 11.17 Revision Log
    Clinical Policy: Abatacept (Orencia) Reference Number: ERX.SPA.123 Effective Date: 10.01.16 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Abatacept (Orencia®) is a selective T cell co-stimulation modulator. FDA Approved Indication(s) Orencia is indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). Orencia may be used as monotherapy or concomitantly with disease- modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists Reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Orencia may be used as monotherapy or concomitantly with methotrexate (MTX) Treatment of adult patients with active psoriatic arthritis (PsA) Limitation(s) of use: Orencia should not be administered concomitantly with TNF antagonists. Orencia is not recommended for use concomitantly with other biologic RA therapy, such as anakinra. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Orencia is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Rheumatoid Arthritis (must meet all): 1. Diagnosis of RA; 2. Prescribed by or in consultation with a rheumatologist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b): a. Failure of a trial of MTX (at up to maximally indicated doses) used for ≥ 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; b.
    [Show full text]