The CorEvitas PsA/SpA Registry (NCT02530268) is a large, independent, prospective, multicenter, non-interventional registry, launched in March 2013, for patients diagnosed with PsA/SpA [17]. Patients are enrolled in the registry by participating rheumatologists. Questionnaires are completed by both patients and their treating rheumatologists during visits, as part of routine clinical care. While data collection is not mandated at regular intervals, rheumatologists are encouraged to complete questionnaires at least every 6 months. As of December 31, 2021, the registry included 2331 actively participating adult patients with PsA, comprising 13,342 visits to 71 rheumatologists from 66 private and academic clinical sites across 30 US states. This represents 7484.9 patient-years of data, with a mean duration of follow-up time of 3.87 years (median 3.05 years).

This study (NCT05195814) included patients aged ≥ 18 years enrolled in the CorEvitas PsA/SpA Registry with rheumatologist-diagnosed PsA, who had initiated tofacitinib as monotherapy at or after registry enrollment, or in combination with oral small molecules (OSM; methotrexate, leflunomide, sulfasalazine, and apremilast [pre-existing use or initiated concurrently]), and had a 6-month follow-up visit (± 3-month window), between December 14, 2017 (date of tofacitinib US Food and Drug Administration approval for PsA) and December 31, 2021. Patients taking tofacitinib in combination with any bDMARD were excluded. The doses of tofacitinib used were not reported.

The study was performed in accordance with Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full board approval for conducting research involving human patients with a limited dataset. Sponsor approval and continuing review were obtained through a central Institutional Review Board (IRB), the New England Independent Review Board (No. 120160939). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to CorEvitas, LLC, prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating in the study.

Data collected at the time of tofacitinib initiation (baseline) included patient demographics (age, sex, and race), comorbidities, PsA clinical features, PsA disease activity measures, and patient-reported outcome (PRO) measures. Outcomes, for which patients were required to have a 6-month follow-up visit (± 3-month window; 6 ± 3-month follow-up visit) after tofacitinib initiation, included clinical effectiveness and PROs at the 6 ± 3-month follow-up visit, and therapy status (treatment discontinuations at or prior to the 6 ± 3-month follow-up visit and reasons for discontinuation). Safety data were not assessed in this analysis.

Clinical effectiveness outcomes included mean change from baseline to month 6 ± 3 in Clinical Disease Activity Index for PsA (cDAPSA), DAPSA, PsA Disease Activity Score (PASDAS), Clinical Disease Activity Index (CDAI), body surface area (BSA), Clinical Global Assessment of PsO, tender joint count (TJC; 68-joint count), and swollen joint count (SJC; 66-joint count).

In addition, the proportions of patients achieving the following at month 6 ± 3 (among those not in each state at baseline) were analyzed: cDAPSA-based low disease activity (LDA; scores > 4 to ≤ 13) and remission (scores ≤ 4), minimal disease activity (MDA; composite measure defined as “yes” if a patient met at least 5 of the 7 following criteria: TJC ≤ 1, SJC ≤ 1, BSA ≤ 3%, patient pain Visual Analog Scale [VAS] ≤ 15, patient global activity VAS ≤ 20, Health Assessment Questionnaire-Disability Index [HAQ-DI] ≤ 0.5, and tender entheseal point ≤ 1), very low disease activity (VLDA; composite measure defined as “yes” if a patient met all 7 criteria included for MDA), PASDAS ≤ 3.2, resolution of enthesitis (Spondyloarthritis Research Consortium of Canada [SPARCC] = 0 for those with SPARCC > 0 at baseline), resolution of dactylitis (no dactylitis at follow-up for those with dactylitis at baseline), Clinical Global Assessment of PsO score of “clear/almost clear” (scores of 0 or 1 for those that were > 1 at baseline), and BSA = 0%. For all outcomes, patients who were in the state of interest (i.e., cDAPSA LDA/remission, MDA, VLDA, PASDAS ≤ 3.2, enthesitis/dactylitis = 0, Clinical Global Assessment of PsO of “clear/almost clear”, and BSA = 0%) at initiation were excluded from the respective analysis.

PROs included mean change from baseline to month 6 ± 3 in scores for patient fatigue (0–100 VAS), patient pain (0–100 VAS), Patient Global Skin Assessment (0–100 VAS), and HAQ-DI, and the proportion of patients with overall work impairment, work time missed, impairment while working, and activity impairment, as measured by the Work Productivity and Activity Impairment (WPAI) questionnaire [18, 19].

For patient demographics and disease characteristics, categorical variables were summarized using frequencies and proportions, and continuous variables were summarized using descriptive statistics (mean and standard deviation [SD]). Therapy status, including rates of discontinuation and reasons for discontinuation, was summarized descriptively (frequency and rate).

For the analysis of clinical effectiveness, binary outcomes were presented as response rates (%) with 95% confidence intervals (CIs) using normal approximation to binomial proportions; non-response was defined as those patients who discontinued tofacitinib prior to the 6 ± 3-month follow-up visit. Summary statistics (n, mean [SD]) were presented for baseline, month 6 ± 3, and difference from baseline in continuous outcomes and PROs. For patients who discontinued prior to 6 ± 3-month follow-up, values prior to discontinuation for continuous outcomes, and non-response for binary outcomes, were used.