NEW YORK (Reuters Health)—Patients with early rheumatoid arthritis (RA) treated with IV tocilizumab alone or with methotrexate maintained clinical benefits during their second year of treatment, researchers say.
Sophie Dimonaco of Roche Products Ltd. in Welwyn Garden City, UK and colleagues sought to determine whether the efficacy and safety of IV tocilizumab, as demonstrated in a previous year-long follow-up, were maintained at two years.
As reported online April 7 in the Annals of the Rheumatic Diseases, the team randomly assigned 1,162 individuals with early RA to 4 mg/kg tocilizumab plus methotrexate (TCZ+MTX); 8 mg/kg TCZ+MTX; 8 mg/kg TCZ + placebo or MTX + placebo for two years.
Those who were not receiving 8 mg/kg TCZ and who were not achieving remission (Disease Activity Score – 28 joints/erythrocyte sedimentation rate no more than 3.2 at the end of one year) were switched to rescue therapy (8 mg/kg TCZ+MTX).
Data were included on 1,157 patients for efficacy and 1,153 for safety.
DAS28-ESR remission rates (less than 2.6) were maintained from the end of the first year to the end of the second year. For example, in the 8 mg/kg TCZ+MTX group, 49.3% achieved remission at year one and 47.6% at year two.
After a year of rescue therapy, 51.4% of patients who switched from MTX + placebo achieved remission, as did 30.5% of those who switched from 4 mg/kg TCZ+MTX.
Both 8 mg/kg TCZ groups maintained inhibition of radiographic progression from the first to the second year.
From a safety perspective, about 96% of adverse events were categorized as mild or moderate across the treatment groups, with infections most frequently reported.
Dimonaco told Reuters Health by email, “These results add to the growing body of research exploring the use of (tocilizumab). In particular, they reinforce findings seen in other studies regarding (its) potential as a treatment for patients with early rheumatoid arthritis.”
Dr. Dennis Ang, section chief, rheumatology and immunology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina told Reuters Health that tocilizumab was previously reserved for patients who failed methotrexate. Because the current study supports its use as initial therapy, “the number of available options for patients with early rheumatoid arthritis has increased.”
“However,” he said by email, “given the expense associated with (the drug), future studies should determine the cost effectiveness of tocilizumab versus methotrexate, with or without anti-TNF agents, before recommending the wider use of tocilizumab for the general population of patients with early rheumatoid arthritis.”
Dr. David Karp, chief of the Division of Rheumatic Diseases at UT Southwestern Medical in Dallas, told Reuters Health the study is “well done,” with outcomes consistent with previous studies of the drug.
“In our clinical practice, (tocilizumab) is useful for the treatment of patients with rheumatoid arthritis who have not responded to less costly agents,” he said by email.
“The data in this paper raise the question whether it is clinically important to use this drug as a first-line therapy,” Dr. Karp noted. “The economics of such a decision are not discussed in the paper, but have been (studied by) other groups. The safety issues were all expected and not particularly concerning.”
The study was funded by Roche, which markets the drug as Actemra. Two authors are employed by companies in the Roche Group, and five have received funding from Roche and other pharmaceutical companies.
Reference
- Burmester GR, Rigby WF, van Vollenhoven RF, et al. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Apr 7. pii: annrheumdis-2016-210561. [Epub ahead of print]
