Healio
Healio
October 29, 2015
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Switching from IV to subcutaneous Actemra found safe, effective in patients with RA

Although investigators of a recently published study deemed it safe and efficacious for patients with rheumatoid arthritis who received monotherapy with Actemra delivered intravenously to switch to subcutaneous delivery, they noted this practice may lead to reduced efficacy in heavier patients.

Researchers studied data from 319 patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate or other conventional or anti-tumor necrosis factor-alpha disease-modifying anti-rheumatic drugs were randomized to receive either 8-mg/kg intravenous (IV) or 162-mg subcutaneous Actemra (tocilizumab; Genentech) monotherapy every 4 weeks or 2 weeks, respectively. The first 24 weeks of study were double-blinded, followed by an open-label extension period with subcutaneous tocilizumab only for up to 84 weeks.

Disease activity was assessed at baseline and every 4 weeks using the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR), Clinical Disease Activity Index (CDAI) scores and the American College of Rheumatology 20% improvement criteria (ACR20).

Patients who received IV tocilizumab had a mean DAS28-ESR score of 2.5 at week 24 and a score of 2.6 at week 36 following the switch to subcutaneous delivery. Patients who received subcutaneous tocilizumab at baseline had a mean DAS28-ESR score of 2.7 at week 24 and 2.6 at week 36.

The mean CDAI score was 8 at week 24 and 8.7 at week 36 for patients who received IV tocilizumab compared with 9.8 and 9.6, respectively, for the patients who received only subcutaneous delivery. Of patients who received IV tocilizumab at baseline, 88.8% met an ACR20 response, while 68.1% met ACR50 and 41.3% met ACR70 criteria at week 24. At week 36, 85% of this group met ACR20, 66.9% met ACR50 and 36.9% met ACR70 responses. For patients who received subcutaneous delivery from baseline, 81.6%, 68.5% and 38.6% met ACR20, ACR50 and ACR70 responses, respectively, while 86.1%, 65.8% and 39.9% had an ACR20, ACR50 and ACR70 response rate, respectively.

Remission rates were similar between groups at both time points. A subanalysis showed patients who remained in the moderate or high disease activity categories tended to have a higher bodyweight than the median for the study. The total number and type of adverse events were similar between groups and at both time points. – by Shirley Pulawski

Disclosure s : Ogata reports receipt of honoraria (less than $10,000 each) from Pzer, UCB Japan, GlaxoSmithKline, Ono, Takeda, Mitsubishi Tanabe and Daiichi Sankyo, and (more than $10,000) from Chugai. Please see the full study for a list of all other authors’ relevant financial disclosures.

Sources/Disclosures

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Source:

Ogata A, et al. Arth Care Res. 2015;doi:10.1002/acr.22598.