Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice

Background Tumour necrosis factor -a inhibitors, including infliximab (IFX), can improve disease control of plaque-t)Te psoriasis. Objectives The Real -World Assessment of Long -Term Infliximab Therapy for Psoriasis (REALITY) study evaluated the efficacy and safety of maintenance IFX therapy in typical clinical settings. Methods In this prospective, observational, open label, mult c ntre study in patients with plaque type psoriasis, IFX 5 mg kg was infused at weeks 0, 2 and 6, and every 8 weeks thereafter during a 50 week treatment phase. The primary outcome was > 75% Psoriasis Area and Severity Index (PASO improvement from baseline to week SO. Patients with > 25% PAST improvement from baseline to the end of the treatment phase were potentially eligible to enter a 48 week extended treatment phase. Response maintenance and other efficacy measures were evaluated. Adverse events (AEs) Were collected. Results In total 660 patients enrolled. Of 521 efficacy-evaluable treatment phase patients (66,7a male, mean age 46.5 years, mean PAST 18.1), 56.8,7a achieved PAST 75 at the end of the treatment phase. Response was maintained at week 50 by 64.700) (205/317) of patients who achieved PAST 75 at week 14. During extended treatment, 66.3% (112/169) of patients attained PAST 75 at week 98; response vs as maintained at week 98 by 71.6 A; (101/141) of those who achieved PAST 75 at week 50. IFX was generally well tolerated. During treatment, 7.6% (50/659) of patients had serious AEs. During extended treatment, 4.1% (eight of 193) of patients had serious AEs. Conclusions PAST 75 response -was achieved by 56.K /o and 66.30)0 of patients at weeks 50 and 98, respectively. The AE pattern was consistent with previous report&