AbbVie Announces Rinvoq Approval

Rinvoq  is the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA.

The EC approval is supported by data from the Phase III SELECT-GCA trial, which was recently published in the New England Journal of Medicine.  In this trial, primary and key secondary endpoints were achieved with  Rinvoq  15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen.

Primary endpoint results from the Phase III  SELECT-GCA trial demonstrated:

• Sustained remission: 46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.002).

Key secondary endpoints included:

• Reduction in disease flares: 34.3% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen experienced at least one disease flare up to week 52 versus 55.6% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.001).
• Lower cumulative steroid exposure: Through 52 weeks, cumulative steroid exposure was significantly lower for patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen than for patients receiving placebo in combination with a 52-week steroid taper regimen (median exposure of 1615 mg versus 2882 mg, respectively; p<0.001).
• Sustained complete remission: 37.1% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remission up to week 52, compared with 16.1% of patients receiving placebo in combination with a 52-week steroid taper regimen (p<0.001).

During the 52-week, placebo-controlled period, the safety profile of Rinvoq was generally consistent with that observed in other approved indications. Similar rates of serious adverse events were observed in patients receiving Rinvoq 15 mg and in those receiving placebo. Serious infections occurred in 5.7% of the Rinvoq 15 mg group and 10.7% of the placebo group. The proportions of patients with events of interest were balanced across treatment groups for incidence of malignancy (excluding nonmelanoma skin cancer; 1.9% in the Rinvoq 15 mg group vs 1.8% in the placebo group) and venous thromboembolism (3.3% in the Rinvoq 15 mg group vs 3.6% in the placebo group). There were no adjudicated major adverse cardiac events (MACEs) in the Rinvoq 15 mg group, compared with two events in the placebo group. Four treatment-emergent deaths were reported, two in the placebo group and two in the Rinvoq 15 mg group. Of the two treatment-emergent deaths in the Rinvoq 15 mg group, one was attributed to Covid-19 and the other was adjudicated as an unexplained cause.

SELECT-GCA (M16-852) is a Phase III, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA (NCT03725202.) The study consists of two parts. The first part, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared with placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The efficacy and safety of withdrawing versus continuing upadacitinib in maintaining remission in participants who achieved sustained remission in the first part will be evaluated in the second part of the study. Top-line results of part one of the study were shared in April 2024.

"GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss,  said Prof. Dr. med. Wolfgang Schmidt, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany and SELECT-GCA trial investigator. "Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ, addressing important patient goals in the treatment of GCA".

See citation- Blockmans D, Penn SK, Setty AR, Schmidt WA et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis.  N Engl J Med. 2025 Apr 2. doi: 10.1056/NEJMoa2413449. Online ahead of print. PMID: 40174237