Rheumatoid Arthritis

SELECT-NEXT Trial: JAK Inhibitor Improves Patient-Reported Outcomes in RA

Daily treatment with upadacitinib, 15 mg or 30 mg, for 12 weeks can lead to significant and clinically meaningful improvements in patient-reported outcomes (PROs) among patients with rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDS), according to a new report on data from post hoc analyses of the SELECT-NEXT clinical trial.

For the trial, the researchers randomly assigned 661 patients with moderate-to-severe active RA to receive either upadacitinib, 15 mg (n=221), upadacitinib, 30 mg (n=219), or placebo (n=221) once daily for 12 weeks. All patients were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

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The following PROs were evaluated:

  • Pain
  • Duration and severity of morning joint stiffness
  • Patient Global Assessment of Disease Activity (PtGA)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
  • 36-item Short Form Health Survey (SF-36)
  • Work Instability Scale for Rheumatoid Arthritis (RA-WIS)

 

“Capturing the patient experience with these outcomes provides important information that can be used by clinicians to guide treatment decisions,” the authors wrote.

Among all the patients, 618 (93%) completed the placebo-controlled 12-week period.

Results showed that patients who received treatment with upadacitinib—either the 15 mg or 30 mg dose—had statistically significant improvements in pain, duration and severity of morning stiffness, PtGA, HAQ-DI, FACIT-Fatigue, SF-36 (physical component summary [PCS] and 6/8 domains), and RA-WIS at 12 weeks.

“Improvements in PtGA, pain, HAQ-DI, and [morning] stiffness were reported as early as week 1,” the authors wrote.

More patients in the upadacitinib groups reported improvements greater than or equal to the minimum clinically important difference in PtGA, pain, HAQ-DI, FACIT-Fatigue, morning stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores of greater than or equal to normative values in HAQ-DI, FACIT-Fatigue, and SF-36 (PCS and 4 or 5/8 domains).

For most of the PROs, the range of the incremental number of patients needed to receive treatment with upadacitinib to report clinically meaningful improvement from baseline was 4 to 8.

The authors noted that there appeared to be little difference in the treatment responses between the upadacitinib 15 mg and 30 mg doses, which was consistent with the primary efficacy results.

A blinded extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib, 15 mg or 30 mg, once daily in participants who had completed the 12-week study period is ongoing.

—Melinda Stevens

 

Reference:

Strand V, Pope J, Tundia N, et al. Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Arthritis Res Ther. 2019;21(1):272. doi:10.1186/s13075-019-2037-1.