ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 519

Patterns of Tocilizumab Use and Safety in Patients with Rheumatoid Arthritis: Interim Results from a Multinational Observational Study

Boulos Haraoui1, Gustavo Casado2, Elke Theander3, Laszlo Czirják4, Andrew Taylor5, Peter Button6, Lykke Hinsch Gylvin7 and Roberto Caporali8, 1Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada, 2Hospital Militar Central, Buenos Aires, Argentina, 3Skane University Hospital Malmö, Lund University, Malmö, Sweden, 4University of Pécs, Pécs, Hungary, 5Royal Perth Hospital, Perth, Australia, 6Roche Products Pty Limited, Dee Why, Australia, 7F. Hoffmann-La Roche, Basel, Switzerland, 8Rheumatology, Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, rheumatoid arthritis, treatment and tocilizumab

  • Tweet
  • Email
  • Print
Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Safety of Biologics and Small Molecules in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: Tocilizumab (TCZ) is indicated for the treatment of patients with RA who have had inadequate responses to DMARDs either as monotherapy (Mono) or in combination with DMARDs (Combo). ACT-UP is an umbrella project with data pooled from several international, observational, postmarketing studies investigating intravenous TCZ use in patients with RA in routine care. Interim observations of patterns of TCZ use, adherence to label recommendations, and safety are reported.

Methods: Adult patients with moderate to severe RA who started TCZ within 8 wk of enrollment were observed in clinical practice for 6 mo. There were no specified dosing regimens (concomitant RA treatments were permitted) and no interventional procedures, clinic visits, or laboratory analyses outside routine practice.

Results: Of 961 patients who received their first TCZ dose by June 30, 2013, 352 (37%) started Mono and 609 (63%) started Combo; 94% and 95% of Mono and Combo  patients, respectively, started TCZ at 8 mg/kg, and 93% and 94% of patients, respectively, who received TCZ at 6 mo received 8 mg/kg. TCZ dose changes were reported for 34 (10%) Mono patients (7 increased, 11 decreased, 16 both increased and decreased) and 68 (11%) Combo patients (13 increased, 20 decreased, 35 both increased and decreased). Reasons for dose changes were AEs for 4% of Mono and 5% of Combo patients and lack of efficacy for 2% of Mono and 1% of Combo patients. Median MTX dose for Combo patients was 15.0 mg/wk. Sixty-three patients changed MTX dose during the study at a median dose change of –5.0 mg/wk. Twenty-eight (8%) patients who started TCZ Mono added a DMARD during the study. Corticosteroids were used by 57% of Mono and 70% of Combo patients (median prednisone-equivalent dose of 7.5 and 5.0 mg/d, respectively, at baseline). At 6 mo, 72% of Mono and 84% of Combo patients were still receiving TCZ. Overall, 100 (10%) patients discontinued TCZ in the first 3 mo and another 94 (10%) discontinued in the next 3 mo. Reasons for discontinuations included lack of efficacy (11% Mono; 27% Combo), adverse events (AEs; 27% Mono, 29% Combo), and other (62% Mono, 44% Combo). Regarding safety, AEs occurred in 53% of patients in each group. AEs classified as infections were less common in Mono than Combo patients (Table). No gastrointestinal perforations were reported in either group. Among patients for whom an AE required TCZ dose modification or an abnormal laboratory test result required follow-up, the investigator reported that local label/protocol recommendations were followed for 98% of Mono and 95% of Combo patients.

Conclusion: In this multinational observational study, 37% of patients started TCZ as monotherapy in clinical practice. Most patients continued TCZ treatment 6 mo after initiation whether they started it as monotherapy or in combination with DMARDs. TCZ was well tolerated in both groups, and adherence to local label recommendations was high.


Disclosure:

B. Haraoui,

Amgen, BMS,

2,

AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, UCB,

5;

G. Casado,

AstraZeneca, AbbVie, GSK, Janssen, Pfizer, Roche,

5;

E. Theander,
None;

L. Czirják,

AbbVie, Pfizer, Roche, UCB, MSD,

5;

A. Taylor,

AbbVie, Roche, Celgene, Janssen, BMS, UCB,

5,

AbbVie, roche, Janssen, BMS, UCB,

8;

P. Button,

Roche Pharmaceuticals,

3;

L. Hinsch Gylvin,

Roche Pharmaceuticals,

3;

R. Caporali,
None.

  • Tweet
  • Email
  • Print

« Back to 2014 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/patterns-of-tocilizumab-use-and-safety-in-patients-with-rheumatoid-arthritis-interim-results-from-a-multinational-observational-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology