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Posted by on Jul 15, 2015 in Rheumatoid Arthritis | 0 comments

In a nutshell

The authors compared the safety and long-term effectiveness of subcutaneous (injected under skin) tocilizumab (Actemra) to intravenous (injected through veins) tocilizumab in patients with rheumatoid arthritis (RA). 

Some background

In RA, the body's immune system mistakenly attacks the joints. Tocilizumab is used to treat RA. Tocilizumab reduces or prevents immune system activity. Intravenous (IV) tocilizumab, approved in several countries for the treatment of RA, is a well tolerated and effective drug. Subcutaneous (SC) tocilizumab has shown similar safety and effectiveness in treating RA. It has also been approved for the treatment of RA in some countries.

However the safety profile for long-term SC tocilizumab use needs to be determined.

Methods & findings

The authors aimed to compare the safety and effectiveness of SC tocilizumab compared to IV tocilizumab over a 97-week period.

1,262 patients participated in this study. For the first 24 weeks, patients were randomly assigned to receive either SC tocilizumab or IV tocilizumab, both in combination with other RA drugs. After 24 weeks, patients receiving SC tocilizumab were randomly reassigned to receive SC or IV tocilizumab for the next 72 weeks. Similarly, patients receiving IV tocilizumab were randomly reassigned to receive SC or IV tocilizumab for 72 weeks. There was a 1 week interval between treatment reassignment.

Patient outcomes were assessed using the American College of Rheumatology (ACR) guidelines and the disability index. ACR guidelines measured 20%, 50% or 70% improvements in swollen or tender joints after treatment. The disability index measured patient activity using a scoring system from 0 to 3. A score of 0 indicated ‘no difficulty’ and a score of 3 indicated ‘cannot be done at all’. Both the SC and IV tocilizumab groups showed similar improvements after treatment. 75.5% of SC patients experienced an ACR response by week 24. This was compared to 78.2% in the IV patient group. 83.6% of SC patients experienced an ACR response by week 97. This was compared to 83.3% in the IV patient group. This response rate was maintained when treatments were randomly switched.

The safety profiles for both SC and IV tocilizumab were similar. The most common side effect reported was infection. 63.2% of the SC group experienced infection, compared to 57.8% in the IV group. Patients who switched from SC to IV treatment had an infection rate of 56.3%. A common side effect in the SC tocilizumab group was an allergic reaction at the site of injection. Treatment safety was similar in patients who only received SC or IV tocilizumab, as well as in patients who switched treatments.

The bottom line

The authors concluded that treatment of RA with SC tocilizumab­ was well tolerated and showed long-term effectiveness which was comparable to that of IV tocilizumab­

Published By :

Annals of the rheumatic diseases

Date :

Jun 08, 2015

Original Title :

Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).

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