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SAT0199 Subcutaneous tocilizumab monotherapy or combined with a csdmard in patients with rheumatoid arthritis: tozura, a pooled analysis of phase iv studies in 22 countries
  1. E Choy1,
  2. R Caporali2,
  3. R Xavier3,
  4. B Fautrel4,
  5. R Sanmarti5,
  6. C Bernasconi6,
  7. A Pethö-Schramm6
  1. 1Cardiff University, Cardiff, United Kingdom
  2. 2University of Pavia, Pavia, Italy
  3. 3Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil
  4. 4Pierre and Marie Curie University, Paris, France
  5. 5Universitat de Barcelona, Barcelona, Spain
  6. 6F. Hoffmann-La Roche AG, Basel, Switzerland

Abstract

Background Tocilizumab administered subcutaneously (TCZ-SC) has been approved for the treatment of rheumatoid arthritis (RA) both as mono- and combination therapy.

Objectives To evaluate the efficacy and safety of TCZ-SC 162 mg once weekly (qw) as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) over 24 weeks in adult patients (pts) with moderate to severe RA.

Methods TOZURA is a multinational, open-label, single-arm umbrella program comprising 7 single-country and 4 regional multicountry protocols (total 22 countries). Pts enrolled were inadequate responders to DMARD, and previous biologic DMARDs were allowed in 8 of 11 protocols. Pts received TCZ-SC 162 mg qw for 24 weeks administered at the investigator's discretion as monotherapy or in combination with a csDMARD. Stable oral NSAIDs and corticosteroids (CS), ≤10 mg/day prednisone or equivalent, were allowed. Efficacy and safety were evaluated at weeks 1, 2, 4 and every 4 weeks for 24 weeks (plus 8 weeks for safety). Propensity score-based matching was used for between-group tests.

Results Of 1804 pts treated, 353 (19.6%) received monotherapy (mono) and 1451 (80.4%) combination therapy (combo); 349 pts (19.3%) had received a prior biologic DMARD. Background characteristics: 81.6% female; mean age, 54.1 years; mean RA duration, 7.7 years; and 82.7% seropositive –similar between treatment groups. Baseline CS was less frequent in the mono vs combo group (41.1% vs 51.2%); however, the mean prednisone equivalent daily dose was similar (6.6 vs 6.5 mg/day, respectively). Pts who continued TCZ to week 24 based on Kaplan-Meier estimates (95% CI) were 79.3% (74.7%>83.2%) for mono and 85.6% (83.7%>87.3%) for combo. DAS28 scores decreased comparably from baseline to week 24 in both groups (mean change: mono −3.40 and combo −3.46), with no significant difference between groups (P =0.61). Results were similar for the Clinical Disease Activity Index (CDAI, mean change by week 24: −23.5 and −23.8, with no significant difference between groups: P=0.42). The proportion of pts who achieved DAS28 or CDAI-based remission, low disease activity or ACR20/50/70/90 responses was similar between groups (Figure 1). In all, 18.2% of pts withdrew; 6.4% did so for safety reasons (mono 9.1%, combo 5.8%). AE rates were similar between groups (Table). Serious AE (SAE) rates were 14.6/100 PY (mono: 22.8/100 PY, combo: 12.8/100 PY). Serious infection and infestation rates were 3.6/100 PY (mono: 4.0/100 PY, combo: 3.5/100 PY) – similar between groups. Six deaths occurred (0.64/100 PY), 1 in the monotherapy group (0.57/100 PY) and 5 in the combination (0.65/100 PY) group.

Conclusions TCZ-SC demonstrated convincing and comparable efficacy as mono- and combination therapy in pts with RA as was previously observed with TCZ-IV. The safety profile of TCZ-SC is consistent with the known safety profile of TCZ as monotherapy and in combination with csDMARDs.

Acknowledgements Funded by F. Hoffmann-La. Roche, Ltd.

Disclosure of Interest E. Choy Grant/research support from: F. Hoffmann-La Roche, Chugai Pharmaceutical, Consultant for: F. Hoffmann-La Roche, Chugai Pharmaceutical, Speakers bureau: F. Hoffmann-La Roche, Chugai Pharmaceutical, R. Caporali Consultant for: AbbVie, Bristol-Myers Squibb, F. Hoffmann-La Roche, UCB and MSD Pharmaceuticals, R. Xavier Consultant for: F. Hoffmann-La Roche, Pfizer, Janssen Pharmaceuticals, AbbVie, Eli Lilly and Company, Speakers bureau: F. Hoffmann-La Roche, Pfizer, Janssen Pharmaceuticals, Abbvie, Eli Lilly and Company, B. Fautrel: None declared, R. Sanmarti: None declared, C. Bernasconi Employee of: F. Hoffmann-La Roche (contractor), A. Pethö-Schramm Employee of: F. Hoffmann-La Roche

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