Patient-reported outcomes in patients with or without enthesitis at baseline
arthritis pain, enthesitis
REGRESSION, HAND ARTHRITIS, ENTHESITIS
Mean FACIT-F total scores for patients with enthesitis (LEI > 0 or SPARCC > 0) at baseline receiving tofacitinib and placebo are shown in Supplementary Fig. 4 (see Additional file At months 1 and 3, among patients with LEI > 0 at baseline, improvements in mean arthritis pain (VAS) scores were greater with tofacitinib 10 mg BID vs placebo across locations, except at month 1 in patients with enthesitis at the Achilles tendon insertion (Supplementary Fig. 4c [see Additional file In patients without enthesitis (LEI = 0 and SPARCC = 0) at baseline, mean FACIT-F total and arthritis pain (VAS) scores through month 3 were similar across treatments (Supplementary Fig. 4e, f [see Additional file PRO scores improved over time with tofacitinib treatment and were maintained to month 6 in patients with enthesitis (LEI > 0 or SPARCC > 0), regardless of baseline location and severity, and were maintained in patients without enthesitis (LEI = 0 and SPARCC = 0) at baseline (Supplementary Fig. 4a–f [see Additional file Multivariable linear regression analyses demonstrated that baseline enthesitis severity assessed by SPARCC was significantly associated with change from baseline in FACIT-F total score at months 3 (When each tofacitinib dose was assessed individually, baseline enthesitis severity assessed by SPARCC was significantly associated with change from baseline in FACIT-F total score with tofacitinib 10 mg BID at month 3 (Baseline enthesitis location and severity assessed by LEI and baseline enthesitis location assessed by SPARCC were not significantly associated with changes from baseline in FACIT-F total score at months 3 and 6, irrespective of tofacitinib dose.Similarly, baseline enthesitis location and severity assessed by LEI and baseline enthesitis location assessed by SPARCC were not associated with changes from baseline in arthritis pain score in the pooled tofacitinib dose group. However, baseline enthesitis severity assessed by SPARCC was significantly associated with change from baseline in arthritis pain score at month 3 (When each tofacitinib dose was assessed individually, enthesitis presence, assessed by LEI, at the lateral epicondyle humerus and Achilles tendon insertion in patients treated with tofacitinib 5 mg BID was significantly associated with change from baseline in arthritis pain score at month 3 (7.8 [1.2, 14.4], There were no significant associations between baseline enthesitis location assessed by SPARCC and change from baseline in arthritis pain score when each tofacitinib dose was assessed individually.