EULAR Annual Congress
EULAR Annual Congress
Source/Disclosures
Source:

Rubbert-Roth A, et al. Abstract SAT0151. Presented at: EULAR 2020 E-Congress; June 3-6, 2020 (virtual meeting).

Disclosures: Rubbert-Roth reports being a consultant for AbbVie, Amgen, BMS, Chugai, Janssen, Lilly, Novartis, Pfizer, Roche and Sanofi.
June 05, 2020
2 min read
Save

Upadacitinib superior to abatacept for DMARD-refractory RA

Source/Disclosures
Source:

Rubbert-Roth A, et al. Abstract SAT0151. Presented at: EULAR 2020 E-Congress; June 3-6, 2020 (virtual meeting).

Disclosures: Rubbert-Roth reports being a consultant for AbbVie, Amgen, BMS, Chugai, Janssen, Lilly, Novartis, Pfizer, Roche and Sanofi.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Data presented at the EULAR 2020 E-Congress demonstrated that upadacitinib was superior to abatacept at improving the signs and symptoms of rheumatoid arthritis among patients with inadequate response to, or intolerance for, biologic DMARDs.

“Remission in rheumatoid arthritis can mean effective disease control and reduced symptoms, which can help patients manage their disease and continue daily activities,” Andrea Rubbert-Roth, MD, deputy director in the division of rheumatology at Cantonal Hospital St. Gallen, Switzerland, told Healio Rheumatology. “Yet, about 70% of treated patients are not achieving clinical remission and are continuing to struggle day-to-day with RA-related symptoms, such as pain and fatigue, despite tremendous treatment advancements.”

Image of arthritic hand
Upadacitinib bested abatacept at improving the signs and symptoms of rheumatoid arthritis among patients with inadequate response to, or intolerance for, biologic DMARDs.

Rubbert-Roth and colleagues conducted the double-blind, randomized, controlled, phase 3 SELECT-CHOICE trial to examine the safety and efficacy of upadacitinib (Rinvoq, AbbVie) vs. abatacept (Orencia, Bristol-Myers Squibb) in patients with inadequate response to or intolerance for biologic DMARDs. SELECT-CHOICE was the sixth and final phase 3 trial in the SELECT RA program, according to Rubbert-Roth.

Investigators randomly assigned patients either 15 mg upadacitinib or IV abatacept at day 1, weeks 2, 4, 8, 12, 16 and 20 at the following doses: < 60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1,000 mg. Background conventional synthetic DMARDs continued among all patients. Blinding lasted for 24 weeks, and adjustments to background medications were made among patients who did not achieve 20% improvement in tender and swollen joint counts at two consecutive visits from baseline to 12 weeks.

The primary endpoint was change in DAS28(CRP) from baseline to 12 weeks (noninferiority), with non-inferiority of upadacitinib vs. abatacept challenge using the 95% CI of the treatment difference against a noninferiority margin of 0.6, according to the researchers. Key secondary endpoints were intended to show superiority of upadacitinib vs. abatacept and included change in DAS28(CRP) from baseline to week 12, and the number of patients achieving complete remission according to DAS28(CRP) (defined as DAS28 < 2.6). Adverse events associated with treatment were reported up to 24 weeks.

The breakdown of prior treatment among the 612 patients who received treatment in the trial was as follows: 67% had received one biologic DMARD (bDMARD), 22% received two and 10% received three or more. Nearly all patients (n = 549) completed 24 weeks of treatment, with adverse effects and withdrawal of consent being the most common reasons for study discontinuation (3.6% and 1.7% in the upadacitinib arm vs. 2.6% and 2.6% in the abatacept arm, respectively).

Primary and key secondary endpoints were met. Change in DAS28(CRP) from baseline to 12 weeks was –2.52 for upadacitinib vs. –2 for abatacept (P < .001), and the proportion of patients who achieved complete remission (defined as DAS28(CRP) < 2.6) was 30% for upadacitinib vs. 13.3% for abatacept (P < .001).

Additionally, more patients in the upadacitinib arm achieved low disease activity (defined as DAS28(CRP) 3.2), ACR20, ACR50 and ACR70 at week 12 compared with patients in the abatacept arm (nominal P < .05). Similarly, at week 24, complete response, ACR50 and ACR70 remained higher in the upadacitinib arm vs. abatacept (nominal P < .05).

However, numerically more patients in the upadacitinib group vs. abatacept experienced treatment emergent adverse events that lead to discontinuation, hepatic disorders and increased creatine phosphokinase (CPK). Additionally, the upadacitinib group included one case of adjudicated major adverse cardiac event (MACE), two cases of adjudicated venous thromboembolism (both patients had at least one risk factor) and one treatment-emergent death. Herpes zoster was reported in four patients in each treatment arm.

“Head-to-head clinical trials like SELECT-CHOICE are important for patients and doctors as they provide further insight into the efficacy and safety of a new treatment compared with established treatment options. The data support the view that upadacitinib presents an important new treatment option for patients who have previously failed a biologic DMARD,” Rubbert-Roth said.