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Patients report sustained improvements in pain and fatigue from taking ixekizumab every 2 or 4 weeks over 3 years.
Ana-Maria Orbai, MD, MHS
Ixekizumab may be an effective treatment to improve pain and fatigue in patients with psoriatic arthritis who have an inadequate response or intolerance to tumor necrosis factor-inhibitors.
The findings were presented at the European E-Congress of Rheumatology 2020 (EULAR 2020) due to the cancellation of the in-person annual meeting, and highlighted improvements in pain and fatigue sustained through 3 years of ixekizumab treatment in the every 2 and every 4 weeks groups.
Ana-Maria Orbai, MD, MHS, conducted SPIRIT-P2, a 156-week, phase 3 study to report such improvements on those treated with ixekizumab for 3 years. The team included patients who met the Classification Criteria for Psoriatic Arthritis (CASPAR) and had an inadequate response or intolerance to 1 or 2 tumor necrosis factor-inhibitors. A placebo group was included through week 24 and the data were derived only from patients in the intent-to-treat population who were randomized to ixekizumab at baseline.
The starting dose was 160 mg, then patients received 80 mg subcutaneous ixekizumab every 2 or 4 weeks. Each patient rated their symptoms with the Joint Pain Visual Analog Scale (0-100 with higher scores representing worse pain). Patients also used the Medical Outcomes Study 36-Item Short Form Health Survey (0 [worst] to 100 [best]) and the Fatigue Severity Numeric Rating Scale (0 [none] to 10 [worst imaginable]). The minimum clinically important difference cutoffs were >10 for Joint Pain Visual Analog Scale, >5 for the 36-item survey, and >3 for the Fatigue Severity Numeric Rating Scale.
Among all patients, 57.4% of those who received ixekizumab every 4 weeks and 44.7% of those who received the drug every 2 weeks completed week 156. The mean change from baseline for Joint Pain Visual Analog Scale was -28.9 (every 4 weeks) and -25.3 (every 2 weeks). More than half of patients (51.8%) of patients reported clinically meaningful joint pain improvement (56.1% every 4 weeks; 47.5% every 2 weeks).
Orbai and the team saw an 18-point improvement in the 36-item survey bodily pain domain at week 156. What’s more, patients had improved fatigue levels. More than 30% of patients achieved the minimum clinically important difference on the Fatigue Numeric Rating Scale (39.4% every 4 weeks; 30.6% every 2 weeks). There was also a 14-point mean improvement in the vitality domain on the 36-Item Short Form Health Survey at week 156.
Pain and fatigue are 2 of the most common symptoms associated with psoriatic arthritis, a chronic and complex inflammatory disease with articular and extra-articular symptoms. Orbai and the investigative team found ixekizumab was an effective treatment to improve pain and fatigue in patients who had an inadequate response or intolerance to tumor necrosis factor inhibitors.
The study, “Improved Pain and Fatigue With Ixekizumab Treatment in Patients With Active Psoriatic Arthritis and Previous Inadequate Response to TNF Inhibitors: Three Year Follow-Up From a Phase 3 Study (SPIRIT-P2),” was published online on the EULAR website.