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Ixekizumab shows sustained improvements in pain and fatigue at 3 years

Presented by
Prof. Ana-Maria Orbai, Johns Hopkins University School of Medicine, USA
EULAR 2020
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.


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