Objective To assess the reliability and validity in ankylosing spondylitis (AS) of selected Patient Reported Outcomes Measurement Information System (PROMIS) Short Forms (SF) developed by the US National Institutes of Health. The analysis was done across core sets and patient-identified domains of the Assessment of Spondyloarthritis international Society. Methods Participants in the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS), an ongoing, prospective longitudinal observational study, completed 6 PROMIS SF assessing global health, depression, fatigue, physical function, pain intensity, and pain interference during their PSOAS visits from September 2017 to January 2019. Test-retest reliability and internal consistency were assessed using intraclass correlation coefficients and Cronbach’s alpha coefficient, respectively. PROMIS SF were compared to legacy measures collected. Construct validity was evaluated through examination of score distributions and floor effects, and through examination of the Spearman correlation coefficients between PROMIS measures and existing legacy AS measures. Discriminant validity was tested across Ankylosing Spondylitis Disease Activity Score (ASDAS) groups. Results Participants (n = 119) were mostly male (69%), white (81%), and with a mean (SD) age of 51 (± 15) years. Legacy measures demonstrated floor effects that were not present in PROMIS SF. Good test-retest reliability (r > 0.8) and excellent internal consistency (α > 0.9) was noted in the PROMIS SF. The 6 PROMIS SF correlated moderately to strongly [ρ 0.68 (Depression) to –0.87 (Physical Function)] with appropriate legacy measures. PROMIS scores measures worsened significantly (p < 0.05) with higher ASDAS groups. Conclusion This study supports the reliability and construct validity of PROMIS SF to assess AS symptoms from a single-center sample of patients with AS. Further research is needed to test responsiveness, feasibility/resource burden, and different cultural/societal contexts for patients with AS.

Objective Ixekizumab is a monoclonal antibody targeting IL-17A and licensed for psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis. Review objectives were to summarize: 1) ixekizumab safety in people with PsA, 2) ixekizumab efficacy from Phase III randomized controlled trials, and 3) ixekizumab study participant PsA phenotypes. Methods We conducted a search in PubMed limited to phase III randomized controlled trials (RCT) and corresponding long-term extension studies where the intervention was treatment with ixekizumab in a population with PsA. Results We identified 17 publications and 13 met inclusion criteria. Injection site reactions (ISR) and allergic reactions occurred in up to 25.3% and 6.2% with ixekizumab and 4.5% and 1.85, respectively, with placebo. ISR occurred in 9.5–10.6% at 24 and 52 weeks with ixekizumab versus 3.2–3.5% with adalimumab (p < 0.01) in biologic-naïve PsA. Serious adverse events at 24 weeks occurred in 8.5% with adalimumab versus 3.5% with ixekizumab (p = 0.02), and at 52 weeks in 12.45 with adalimumab and 4.25 with ixekizumab (p < 0.01). Ixekizumab had similar efficacy to adalimumab across all PsA musculoskeletal, symptom and patient-reported outcome domains and surpassed adalimumab in psoriasis outcomes as well as all combined musculoskeletal and psoriasis outcomes. The study subject population was overwhelmingly white, balanced men-women, BMI at the obese threshold, had on average 7-year PsA duration and 15-year psoriasis duration. Disease activity was high with 7/66 swollen joints, 13/68 tender joints, 55% enthesitis, variable dactylitis (12–51%), and active psoriasis in >92%. Conclusion Ixekizumab treatment in PsA was associated with a statistically significant higher risk of injection site reactions versus placebo or adalimumab. Ixekizumab had statistically significantly fewer serious adverse events than adalimumab. Ixekizumab demonstrated efficacy for all PsA disease activity domains as well as for slowing radiographic disease progression. The main shortcoming of the ixekizumab PsA program is lack of representation of African American study participants.

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