New JAK Inhibitor Approved for Rheumatoid Arthritis

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AbbVie announced on Friday that the Food and Drug Administration approved the oral once-daily JAK inhibitor Rinvoq (upadacitinib) for adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

The approval was based, in part, on the results five phase three clinical trials (called SELECT) of 4,400 rheumatoid arthritis patients. In a statement issued on Friday, AbbVie stated that Rinvoq met all primary and secondary endpoints, which include:

• In SELECT-EARLY, 52 percent of methotrexate naïve patients treated with Rinvoq 15 mg achieved ACR50 vs 28 percent treated with methotrexate at week 12.

• In SELECT-MONOTHERAPY, 68 percent of methotrexate-IR patients treated with Rinvoq 15 mg achieved ACR20 vs 41 percent treated with continued methotrexate at week 14.

• In SELECT-COMPARE, 71 percent of methotrexate -IR patients treated with Rinvoq 15 mg plus methotrexate achieved ACR20 vs 36 percent treated with placebo plus methotrexate at week 12.

• In SELECT-NEXT, 64 percent of csDMARD-IR patients treated with Rinvoq 15 mg plus csDMARDs achieved ACR20 vs 36 percent treated with placebo plus csDMARDs at week 12.

• In SELECT-BEYOND, 65 percent of biologic-IR patients treated with Rinvoq 15 mg plus csDMARDs achieved ACR20 vs 28 percent treated with placebo plus csDMARDs at week 12.

• Durable remission rates were observed up to week 26, the company reported. Forty-eight percent of patients treated with Rinvoq alone in SELECT-EARLY and 41 percent of patients treated with Rinvoq plus methotrexate in SELECT-COMPARE achieved clinical remission at weeks 24 and 26, compared to nine percent with placebo plus methotrexate and 18 percent with methotrexate, respectively.

SEE RELATED:  RA Q&A with the Investigator

RADIOGRAPHIC INHIBITION
RINVOQ significantly inhibited radiographic progression as measured by the change in modified total Sharp score (mTSS) from baseline compared to methotrexate in SELECT-EARLY (0.14 vs 0.67) and RINVOQ plus methotrexate compared to placebo plus methotrexate in SELECT-COMPARE (0.15 vs 0.78) through weeks 24 and 26, respectively.

SAFETY
The most common side effects associated included upper respiratory tract infections (common cold, sinus infections), nausea, cough and pyrexia. And, as with most biologics, the treatment raises the risk of infections, such as tuberculosis and infections caused by bacteria, fungi, or viruses.

Rinvoq, with a recommended dosage of 15 mg, is expected to be available in late August. It is the third FDA-approved JAK inhibitor for rheumatoid arthritis. The others include baricitinib (Olumiant, Lilly) and tofacitinib (Xeljanz, Pfizer).