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FDA News - June 2018

A brief overview of new rheumatology drugs approved by the FDA between May 14, 2018, and June 1, 2018.

Subcutaneous Tocilizumab Approved for Polyarticular Juvenile Idiopathic Arthritis

Subcutaneous Tocilizumab Approved for Polyarticular Juvenile Idiopathic Arthritis

On May 14, 2018, the FDA approved the subcutaneous formulation of tociliz­umab (Actemra; Genentech), an interleukin-6 receptor antagonist, for the treatment of patients aged ≥2 years with active polyarticular juvenile idiopathic arthritis (PJIA). Subcutaneous tociliz­umab can be administered alone or in combination with methotrexate for the treatment of PJIA.

An intravenous (IV) formulation of tocilizumab was approved by the FDA in 2013 for the treatment of PJIA in patients aged ≥2 years. The drug was also previously approved for the treatment of adults with moderate-to-severe rheumatoid arthritis and adults with giant cell arteritis.

This expanded FDA approval was based on data from the 52-week, open-label, multicenter phase 1b JIGSAW-117 bridging trial (N = 52) that aimed to determine, across a range of body weights, the appropriate dosing regimen of the drug based on body weight in children with PJIA who were refractory to or intolerant of methotrexate and who were tocilizumab-naive or were receiving IV tocilizumab with adequate disease control. The efficacy of subcutaneous tociliz­umab in patients aged 2 to 17 years was extrapolated from previous clinical trial results of patients with PJIA who received IV tocilizumab and patients with rheumatoid arthritis who received subcutaneous tocilizumab.

The safety profile of subcutaneous tocilizumab was consistent with the known safety profile of IV tocilizumab. However, patients who received subcutaneous tocilizumab for PJIA in the JIGSAW-117 trial experienced a higher frequency of injection-site reactions (28.8%) compared with patients who received subcutaneous tocilizumab approved for other indications. All reactions reported during the study were mild and did not require withdrawal from treatment. Patients who received subcutaneous tocilizumab also had decreased neutrophil counts (15.4%).

Baricitinib Receives Approval for Treatment of Moderate-to-Severe RA

Baricitinib Receives Approval for Treatment of Moderate-to-Severe RA

On June 1, 2018, the FDA approved baricitinib (Olumiant; Eli Lilly), an oral Janus kinase inhibitor, in a 2-mg once-daily dose for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) who have had an inadequate response to ≥1 tumor necrosis factor inhibitors.

“Despite the advancements we’ve seen in the RA treatment landscape over the past several decades, many patients are still failing to achieve their disease management goals. As it’s important for RA patients to have multiple treatment options available to best suit their disease characteristics and experiences, the approval of Olumiant is very encouraging for our community,” said Seth Ginsberg, Co-founder and President of CreakyJoints and the Global Healthy Living Foundation.

This approval was based on the results of the randomized, double-blind, placebo-controlled RA-BEACON clinical trial, in which patients were randomized to receive baricitinib 2 mg, baricitinib 4 mg, or placebo, plus conventional disease-modifying antirheumatic drugs they were already using. The trial included 527 patients who had an inadequate response or were intolerant to ≥1 tumor necrosis factor inhibitors. Patients could also have been previously treated with other biologic disease-modifying antirheumatic drugs.

At 12 weeks, 49% of patients treated with baricitinib achieved the American College of Rheumatology 20% criteria for improvement (ACR20) response rates and improvement in all individual ACR20 component scores compared with 27% of patients in the placebo group. Patients in the baricitinib arm showed significant improvements in physical function based on the Health Assessment Questionnaire Disability Index, with an average score of 1.71 before treatment and 1.31 at week 12 compared with patients in the placebo group, who had an average score of 1.78 before treatment and 1.59 at week 12.

The most common (≥1%) adverse events in placebo-controlled trials of patients receiving baricitinib 2 mg or baricitinib 4 mg included upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

Baricitinib was approved with a boxed warning advising of the risk for serious infections, malignancies, and thrombosis.

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