Ixekizumab shows sustained improvements in pain and fatigue at 3 years

Patients suffering from psoriatic arthritis often report pain and fatigue. Previous studies have demonstrated improvements in pain and fatigue for up to 2 years with ixekizumab in patients who had an inadequate response or intolerance to tumour necrosis factor inhibitors (TNFi). At the EULAR 2020 meeting, Prof. Ana-Maria Orbai (Johns Hopkins University School of Medicine, USA) presented the 3-year follow-up outcomes of the SPIRIT-P2 trial [1-3].

The 156-week, phase 3 SPIRIT-P2 study included patients who met the Classification Criteria for Psoriatic Arthritis (CASPAR) and had an inadequate response or intolerance to 1 or 2 TNFi. Although there was a placebo group through week 24, this data was derived only from patients in the intent-to-treat population randomised to ixekizumab at baseline. The 244 participants were randomised to 80 mg subcutaneous ixekizumab every 2 (Q2W; n=123) or 4 weeks (Q4W; n=122) after they received a 160 mg starting dose. Their baseline characteristics are outlined in the Table.

Table: Baseline characteristics [1]

Mean (standard deviation) unless stated otherwise.

Participants self-rated their symptoms using the Joint Pain Visual Analog Scale (Joint Pain VAS; ranging from 0 [none] to 100 [worst imaginable]), the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36; ranging from 0 [worst] to 100 [best]), and the Fatigue Severity Numeric Rating Scale (Fatigue NRS; 0 [none] to 10 [worst imaginable]). The minimum clinically important difference (MCID) cut-offs were ≥10 for Joint Pain VAS, ≥5 for SF-36 domains, and ≥3 for Fatigue NRS.

The 156 weeks of treatment was completed by 57.4% of patients in the ixekizumab Q4W group and 44.7% of those in the ixekizumab Q2W group. At week 156, mean change from baseline for the Joint Pain VAS was -28.9 (ixekizumab Q4W) and -25.3 (ixekizumab Q2W). Clinically meaningful improvement of joint pain was reported by 51.8% of patients on ixekizumab (56.1% ixekizumab Q4W and 47.5% ixekizumab Q2W) at week 156. Patients reported an 18-point mean improvement in the SF-36 bodily pain domain. Patients also reported improvements in fatigue up to week 156, with 35.0% of patients achieving the MCID on the Fatigue NRS (39.4% ixekizumab Q4W and 30.6% ixekizumab Q2W). Improvement in fatigue was supported by a 14-point mean improvement in the vitality domain of the SF-36 at week 156.

The researchers concluded that improvements regarding pain and fatigue in patients with psoriatic arthritis with an inadequate response or intolerance to TNFi were sustained through 3 years of ixekizumab treatment in both the Q2W and Q4W treatment groups.

1. Orbai A-M, et al. Abstract FRI0357. EULAR E-Congress, 3-6 June 2020.
2. Kavanaugh A, et al. Clin Exp Rheumatol. 2019;37(4):566-574.
3. Turkiewicz A, et al. Arthritis Rheumatol. 2018;70(S9):2577.

 



Posted on 14 August 202016 February 2024