This site is intended only for all Healthcare Professionals residing in South Africa

Search

Menu

Close

Sign InLog Out Our medicinesTherapy areasExplore contentExplore contentEventsDownloadable materialsVideosLet’s connectLet's ConnectContact usPfizer medical information

Menu

Close

Rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Psoriatic arthritis (PsA) Psoriatic arthritis (PsA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Ulcerative colitis (UC) Ulcerative colitis (UC) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions
Efficacy

The ORAL Solo RCT was designed to assess the efficacy and safety of XELJANZ® (tofacitinib) monotherapy in patients with active RA, who had prior inadequate responses to cDMARDs or bDMARDs.1

Statistically significant changes from baseline were reported at week 2 and months 1 and 2 for XELJANZ® (tofacitinib) versus placebo and further improvement occurred through month 6, with more patients receiving tofacitinib reported improvements.1

 Study Design

A 12-month, randomized, double-blind, controlled, multicenter study in which 717 patients with moderately to severely active RA who had an inadequate response to MTX received XELJANZ® (tofacitinib) 5 mg BID or 10 mg BID, adalimumab 40 mg SC q 2 wk, or placebo, all with background MTX. At month 3, placebo patients who were considered non-responders were randomly assigned to receive XELJANZ® (tofacitinib) 5 mg BID or 10 mg BID + MTX. At month 6, all remaining placebo patients were switched to XELJANZ® (tofacitinib) or MTX. The coprimary endpoints were ACR20 response and DAS28-4(ESR) <2.6 at month 6, and HAQ-DI at month 3.3

The ORAL Scan phase III study was designed to examine structural preservation, improvements in signs and symptoms of RA, and physical function, and to evaluate safety and tolerability of tofacitinib in patients with RA with an inadequate response to MTX.4

Tofacitinib 5mg BID demonstrated sustained efficacy and manageable safety over 24 weeks in patients with active RA when used as monotherapy or in combination with background MTX.4

 Tofacitinib has proven clinically efficacious:4
  • A significant improvement in ACR20/50/70 responses for each tofacitinib dose versus placebo was seen by month 1
  • The proportion of patients with no radiographic progression (≤ 0.5 unit increase from baseline in total SHS) at months 6 and 12 was similar in both tofacitinib treated groups and significantly greater than in the placebo-treated group (both P ≤ 0.05)
  • The proportion of patients with no progression in erosion score at month 12 was significantly greater in both tofacitinib-treated groups versus the placebo-treated group (P ≤ 0.05)

Example

Study Design

ORAL Scan: A 24-month, randomized, double-blind, placebo-controlled, multicenter study in which 797 patients with moderately to severely active RA who had an inadequate response to MTX received XELJANZ® (tofacitinib) 5 mg BID or 10 mg BID or placebo with background MTX. At month 3, placebo patients who were considered nonresponders were randomly assigned to receive XELJANZ® (tofacitinib) 5 mg BID or 10 mg BID + MTX. At month 6, all remaining placebo patients were switched to XELJANZ® (tofacitinib) + MTX. The coprimary endpoints were ACR20 response, mTSS, and DAS28-4(ESR) <2.6 at month 6, and HAQ-DI at month 3.4

The ORAL Strategy study showed that XELJANZ® (tofacitinib) 5 mg BID + MTX proved to be non-inferior to adalimumab 40 mg + MTX and it achieved clinically meaningful responses in MTX-Inadequate responder patients.5

  • XELJANZ® (tofacitinib) + MTX was noninferior to adalimumab + MTX, with both achieving clinically meaningful responses as measured by ACR50 at month 65
  • XELJANZ® (tofacitinib) monotherapy was not shown to be noninferior to XELJANZ® (tofacitinib) + MTX5
  • XELJANZ® (tofacitinib) monotherapy was not shown to be noninferior to adalimumab + MTX5
  • Clinically relevant efficacy responses were seen across all 3 treatment arms5
 Proportion of patients in the full analysis set who had an ACR response5

In patients with an inadequate response to MTX the addition of tofacitinib is efficacious and more effective than switching to tofacitinib monotherapy.5

Study DesignORAL Strategy was a 1 year, double-blind, triple-dummy, phase 3b/4, active comparator, head-to-head controlled trial assessing non-inferiority between treatment groups of tofacitinib 5 mg BID monotherapy (n= 384), tofacitinib 5 mg BID in combination with MTX (n= 376), and adalimumab 40 mg every other week with MTX (n= 386), in patients with active RA despite MTX treatment.5 

The primary endpoint was the proportion of patients attaining an ACR response of at least 50% (ACR50) at 6 months. ACR50 as a composite measure of disease activity has been shown to be a more valid endpoint than ACR20 in head-to-head trials comparing active treatment arms.5Abbreviations:conventional non-biologic disease-modifying anti-rheumatic drug; DAS28-4[ESR]: Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; IR: inadequate responder; IVRS: Interactive Voice Response Systems; LOCF: last observation carried forward; mTSS: modified Total Sharp Score; MTX: methotrexate; NRI: non-responder imputation; NS: nonsignificant; PtGA: Patient Global Assessment of Disease Activity; q 2 wk: every 2 weeks; RA: rheumatoid arthritis; RCT: randomized control trial; SF-36 PCS: Short Form-36 Physical Component Summary
ReferencesStrand V, Kremer J, Wallenstein G, et al. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs. Arthritis Res Ther. 2015;17(307): 1-12. doi: 10.1186/s13075-015-0825-9.Fleischmann R, Kremer J, Cush J, et al. for the ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495-507.van Vollenhoven RF, Fleischmann R, Cohen S, et al. for the ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367(6):508-519.van der Heijde D, Tanaka Y, Fleischmann R, et al. and the ORAL Scan Investigators. Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four–month phase III randomized radiographic study. Arthritis Rheum. 2013;65(3): 559-570.Fleischmann R, Mysler E, Hall S, et al. on behalf of the ORAL Strategy Investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017;390(10093):457-468.
PP-XEL-ZAF-0083

Copyright ©2024 Pfizer South Africa All rights reserved.

  • The information contained herein is provided for educational purposes only and is not intended to constitute medical advice or replace discussions with a Healthcare Professional. All decisions regarding patient care must be made with a Healthcare Professional, considering the unique characteristics of the patient.
  • While every effort is made to update the information regularly and to offer the most current, correct and clearly expressed information possible, Pfizer cannot be held responsible for any inaccuracy, errors, omissions or misinterpretations.
  • Pfizer, its officers and/or its employees do not accept or take any responsibility whatsoever for any loss, whether direct, indirect or consequential, which may arise from reliance on information contained on these pages and actions resulting therefrom. Any liability that would or could arise as a result of the contents of these pages is hereby excluded to the fullest extent allowed by law.
  • No warranty is given that any files, downloads or applications available via this web site are free of viruses which have the ability to corrupt your system.
  • Any and all information is subject to change without notice.
  • The information provided in this site is intended only for appropriate Healthcare Professionals residing in South Africa.

 

PfizerPro AccountPfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign inRegisterAccountSign Out

This site is intended only for all Healthcare Professionals residing in South Africa. If you are a member of the public wishing to access information on a specific medicine, please visit www.pfizer.co.za.

 

This website is brought to you by Pfizer South Africa 

Pfizer Laboratories (Pty) Ltd. Company Reg. No. 1954/000781/07. Building 2, 1st Floor, Maxwell Office Park, Magwa Crescent, Waterfall City, Midrand, Johannesburg, South Africa. Tel. No: 0860 PFIZER (734937).

 

Copyright © 2024. Pfizer Laboratories (Pty) Ltd. All rights reserved

PP-UNP-ZAF-0309
For South Africa Healthcare Professionals *


These pages are not intended for patients or for members of the general public. The healthcare professional webpages contain promotional content.

I confirm that I am a healthcare professional residing in South Africa. If you select 'No', you will be redirected to Pfizer.co.za where you will be able to access reference information on Pfizer's prescription medicines.
 

Yes No
You are now leaving the PfizerPro South Africa website
You are leaving the South Africa HCP Portal website and being directed to a new website

This website is not controlled by South Africa HCP portal or subject to our privacy policy.

Thank you for visiting our site. We hope your visit was informative and enjoyable
You are now leaving PfizerPro You are now leaving PfizerPro and will be directed to our provider to complete your registration. Any personal information that you may find prepopulated from your PfizerPro profile, or you may provide, will be governed by Privacy Policy. Your data will not be used for any other purpose.

PP-UNP-ZAF-0303