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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.

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.5
Abbreviations: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.
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