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Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial
J.M. Kremer1, R. Blanco2, A.-M. Halland3, M. Brzosko4, R. Burgos-Vargas5, C.M. Mela6, L. Rowell7, R.M. Fleischmann8
- Albany Medical College, Albany, New York, USA. jkremer@joint-docs.com
- Hospital Marques de Valdecilla, IDIVAL, Santander, Spain.
- Panorama Medical Center, Cape Town, South Africa.
- Rheumatology and Internal Diseases Clinic, Pomeranian Medical University, Szczecin, Poland.
- Hospital General de México and Universidad Nacional Autónoma de México, Mexico City, Mexico.
- Roche Products Ltd., Welwyn Garden City, UK.
- Roche Products Ltd., Welwyn Garden City, UK.
- Metroplex Clinical Research Center, Dallas, Texas, USA.
CER8983
2016 Vol.34, N°4
PI 0625, PF 0633
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PMID: 27087059 [PubMed]
Received: 17/09/2015
Accepted : 08/01/2016
In Press: 15/04/2016
Published: 14/07/2016
Abstract
OBJECTIVES:
To report 5-year efficacy and safety in rheumatoid arthritis (RA) patients with active disease treated with tocilizumab.
METHODS:
LITHE was a 2-year, randomised, placebo-controlled study of tocilizumab in RA patients (ClinicalTrials.gov, NCT00106535), with an additional 3-year, open-label extension. Patients were randomly assigned to tocilizumab (4 or 8 mg/kg IV) or placebo every 4 weeks + methotrexate. They could receive rescue with tocilizumab from week 16; after week 52, patients could switch to open-label tocilizumab 8 mg/kg. Radiographs were analysed by randomized treatment using the Genant-modified Total Sharp Score (GmTSS). Patients with at least baseline, week 104 and post-week 104 radiographs were included. Clinical and safety data were pooled for all patients who received ≥1 dose of tocilizumab; results are presented from the first tocilizumab dose.
RESULTS:
1,149 patients were included with 4,380 patient-years of exposure; 34% received 5 years of treatment. Mean 5-year change in GmTSS revealed greater inhibition of radiographic progression in tocilizumab patients than placebo patients (1.34 vs. 3.02), with the greatest annualised progression rate in year 1. Overall, 53% of tocilizumab and 35% of placebo patients experienced no progression (GmTSS ≤0). Clinical benefit was maintained - determined by ACR response, DAS28-ESR <2.6, EULAR good/moderate response and Boolean remission – as was physical function. The safety profile over 5 years was similar to that over 2 years.
CONCLUSIONS:
Over 5 years, tocilizumab + MTX inhibited radiographic progression and maintained improvements in signs and symptoms and physical function in MTX-inadequate responders with active disease; no new safety signals occurred.
