Is tocilizumab a safe and effective treatment for early rheumatoid arthritis?
In a nutshell
This study investigated if tocilizumab (Actemra) monotherapy or combination therapy with methotrexate (Trexall) was safe and effective in the long-term for treating patients with early rheumatoid arthritis (RA).
They found that the tocilizumab alone (monotherapy) and in combination with methotrexate was safe and effective at 2 years in treating these patients.
Rheumatoid arthritis is an autoimmune disease where the body’s immune system attacks healthy joint tissue and causes irreversible damage. Treatment strategies aim to reduce the immune response. Standard first-line treatment for many patients is methotrexate. This medication suppresses the immune system via multiple targets. Some patients do not respond well to methotrexate. Tocilizumab acts as an immune suppressor by targeting a pro-inflammatory receptor, interleukin-6 receptor alpha.
Studies have shown that tocilizumab alone and in combination with methotrexate can be an effective treatment for early RA. The long-term safety of this treatment is still under investigation.
Methods & findings
This study examined the long-term effects of tocilizumab to assess the safety and effectiveness of the medication.
1162 patients were included in this study. These patients were diagnosed with early RA and had not yet received methotrexate treatment. Patients were randomly assigned to 4 groups. Two groups combined 8 mg/kg or 4 mg/kg tocilizumab (TCZ) and methotrexate (MTX); the other groups were TCZ (8 mg/kg) with placebo (substance with no active effect) and MTX with placebo. Treatment was continued for 104 weeks. The disease activity score (DAS28-ESR) of each patient was assessed.
After 2 years of treatment, patients receiving 8 mg/kg TCZ alone or in combination with MTX had improved disease activity and reduced joint damage.
Safety assessments noted 83 serious adverse events in the 8 mg/kg TCZ with MTZ group, and 67 in the 8 mg/kg TCZ with placebo group. The most common adverse event was infection, which was similar across all groups. Adverse events were similar at week 104 compared to week 52.
The bottom line
This study concluded that tocilizumab is safe and effective for the treatment of early RA.
Source: Annals of Rheumatic Diseases, Apr 07, 2017