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Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)
  1. Gerd R Burmester1,
  2. Andrea Rubbert-Roth2,
  3. Alain Cantagrel3,
  4. Stephen Hall4,
  5. Piotr Leszczynski5,
  6. Daniel Feldman6,
  7. Madura J Rangaraj7,
  8. Georgia Roane8,
  9. Charles Ludivico9,
  10. Min Bao10,
  11. Lucy Rowell11,
  12. Claire Davies11,
  13. Eduardo F Mysler12
  1. 1Free University and Humboldt University of Berlin, Berlin, Germany
  2. 2Klinikum der Universität zu Köln, Köln, Germany
  3. 3Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  4. 4Cabrini Medical Centre, Malvern, Australia
  5. 5Poznan Medical University, Poznan, Poland
  6. 6Universidade Federal de São Paulo, São Paulo, Brazil
  7. 7Arthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA
  8. 8Rheumatology Associates of South Carolina, Charleston, South Carolina, USA
  9. 9East Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA
  10. 10Genentech Inc, South San Francisco, California, USA
  11. 11Roche Products Limited, Welwyn Garden City, UK
  12. 12Organizacion Medica de Investigación, Buenos Aires, Argentina
  1. Correspondence to Dr Gerd R Burmester, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; gerd.burmester{at}charite.de

Abstract

Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).

Methods Patients (n=1262) were randomised 1:1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11:1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SC–IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV–SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.

Results The proportions of patients who achieved American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index ≥0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed.

Conclusions The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.

Trial registration number NCT01194414.

  • Rheumatoid Arthritis
  • DMARDs (biologic)
  • Treatment

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