FDA News

FDA approves Rinvoq for methotrexate-refractory RA

Roy M. Fleischmann

The FDA has approved upadacitinib, a 15-mg, once-daily oral JAK inhibitor, for the treatment of moderate-to-severe rheumatoid arthritis among patients who have had an inadequate response to methotrexate, according to an AbbVie press release.

“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity — the primary treatment goals for rheumatoid arthritis,” Roy M. Fleischmann, MD, of the University of Texas Southwestern Medical Center in Dallas, said in the release. “With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”

The FDA based their approval of Rinvoq (upadacitinib) on data from the SELECT program, a collection of five phase 3 studies that included approximately 4,400 patients with RA across all treatment arms. The studies assessed efficacy, safety and tolerability in a variety of patients with RA, including those who were unresponsive or intolerant to biologic DMARDs, and those who had not received, or had an inadequate response to, methotrexate.

According to the press release, Rinvoq achieved all primary and ranked secondary endpoints across all five SELECT phase 3 studies, including:

  • SELECT-EARLY: 52% of patients who had not received methotrexate and treated with Rinvoq demonstrated ACR50, compared with 28% of those treated with methotrexate, at week 121;
  • SELECT-MONOTHERAPY: 68% of patients who had an inadequate response to methotrexate and were treated with Rinqov achieved ACR20, compared with 41% of those who continued with methotrexate, at week 141;
  • SELECT-COMPARE: 71% of patients who had an inadequate response to methotrexate and were treated with Rinqov plus methotrexate demonstrated ACR20, compared with 36% treated with placebo plus methotrexate, at week 121;
  • SELECT-NEXT: 64% of patients who had an inadequate response to conventional synthetic DMARDs and treated with Rinvoq plus conventional synthetic DMARDs achieved ACR20, compared with 36% of those treated with placebo plus conventional synthetic DMARDs, at week 121; and
  • SELECT-BEYOND: 65% of patients with an inadequate response to biologics and treated with Rinvoq plus conventional synthetic DMARDs demonstrated ACR20, compared with 28% of those treated with placebo plus conventional synthetic DMARDs, at week 12.

“The discovery and development of Rinvoq is indicative of AbbVie's long-standing commitment to advancing the science for people living with immune-mediated conditions,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release. “Today’s FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis.”

Roy M. Fleischmann

The FDA has approved upadacitinib, a 15-mg, once-daily oral JAK inhibitor, for the treatment of moderate-to-severe rheumatoid arthritis among patients who have had an inadequate response to methotrexate, according to an AbbVie press release.

“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity — the primary treatment goals for rheumatoid arthritis,” Roy M. Fleischmann, MD, of the University of Texas Southwestern Medical Center in Dallas, said in the release. “With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”

The FDA based their approval of Rinvoq (upadacitinib) on data from the SELECT program, a collection of five phase 3 studies that included approximately 4,400 patients with RA across all treatment arms. The studies assessed efficacy, safety and tolerability in a variety of patients with RA, including those who were unresponsive or intolerant to biologic DMARDs, and those who had not received, or had an inadequate response to, methotrexate.

According to the press release, Rinvoq achieved all primary and ranked secondary endpoints across all five SELECT phase 3 studies, including:

  • SELECT-EARLY: 52% of patients who had not received methotrexate and treated with Rinvoq demonstrated ACR50, compared with 28% of those treated with methotrexate, at week 121;
  • SELECT-MONOTHERAPY: 68% of patients who had an inadequate response to methotrexate and were treated with Rinqov achieved ACR20, compared with 41% of those who continued with methotrexate, at week 141;
  • SELECT-COMPARE: 71% of patients who had an inadequate response to methotrexate and were treated with Rinqov plus methotrexate demonstrated ACR20, compared with 36% treated with placebo plus methotrexate, at week 121;
  • SELECT-NEXT: 64% of patients who had an inadequate response to conventional synthetic DMARDs and treated with Rinvoq plus conventional synthetic DMARDs achieved ACR20, compared with 36% of those treated with placebo plus conventional synthetic DMARDs, at week 121; and
  • SELECT-BEYOND: 65% of patients with an inadequate response to biologics and treated with Rinvoq plus conventional synthetic DMARDs demonstrated ACR20, compared with 28% of those treated with placebo plus conventional synthetic DMARDs, at week 12.

“The discovery and development of Rinvoq is indicative of AbbVie's long-standing commitment to advancing the science for people living with immune-mediated conditions,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release. “Today’s FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis.”