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November 10, 2021

AbbVie reports results of Rinvoq in Phase III rheumatoid arthritis trial

The Phase III trial categorised subjects to receive a 15mg or 30mg once-daily oral dose of upadacitinib or a placebo for 12 weeks.

AbbVie has reported data from a post-hoc analysis of the Phase III SELECT-BEYOND clinical trial of Rinvoq (upadacitinib) in people suffering from moderate to severe rheumatoid arthritis (RA), an autoimmune disease.

These subjects had previously failed or were found to be not tolerant to at least one biologic treatment.

Trial findings demonstrated that 34% of the subjects receiving Rinvoq and background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) attained clinical disease activity index (CDAI) remission at first incidence of response before week 60.

Nearly 79% of the patients attained CDAI low disease activity (LDA).

A selective inhibitor of Janus kinase, Rinvoq is currently being assessed for various immune-mediated inflammatory diseases.

The placebo-controlled, randomised Phase III trial categorised subjects to receive 15mg or 30mg once-daily oral dose of upadacitinib or a placebo for 12 weeks.

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On completing 12 weeks, the subjects in the placebo arm received 15mg or 30mg doses of upadacitinib.

At 60 weeks, response maintenance was observed for CDAI remission and CDAI LDA in 39% and 61% of the subjects, respectively.

Maintenance of response is described as having a response for two consecutive visits as part of the trial.

Of the subjects receiving Rinvoq and lost CDAI remission, 58% continued in CDAI LDA while 22% regained remission by the assessment cut-off time.

AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson said: “Many people living with rheumatoid arthritis continue to experience debilitating joint pain and decreased physical functioning despite being on therapy.

“These data underscore the potential of Rinvoq to be an important treatment option to help people who face the daily challenges of rheumatoid arthritis.”

In another development, AbbVie reported post-hoc analyses data from Phase III SELECT-PsA 1 and SELECT-PsA 2 trials of upadacitinib on axial symptoms in adults with active psoriatic arthritis (PsA) and axial involvement.

In both trials, active PsA patients had improved clinical responses linked to their axial involvement with upadacitinib versus placebo at week 24.

AbbVie reported combined positive results from two Phase III clinical trials of risankizumab (Skyrizi) in adult patients with active psoriatic arthritis (PsA) earlier this week.

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