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OTEZLA IMPROVES AXIAL SYMPTOMS AS ASSESSED BY BASDAI1*

Reduction in BASDAI score sustained at 3 years1

PSA-DST-AXIL-SYMP
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aPALACE 1-3 pooled analysis. LOCF; includes patients randomized to OTEZLA 30 mg BID or placebo at baseline.

bData as observed; includes patients who were randomized to OTEZLA 30 mg BID at baseline and remained on treatment for 156 weeks.

cP = 0.0002 vs placebo.

dMCID for BASDAI = -1.1 point improvement.2

During the placebo-controlled period, at week 16, patients taking OTEZLA 30 mg BID achieved a greater mean decrease in BASDAI score vs patients taking placebo (-1.53 vs -0.91; P = 0.0173).1†

*Pooled patient data from PALACE 1-3; BASDAI score was an exploratory measure in the subset of patients with axial symptoms and a baseline BASDAI score of >4 (n=454); BASDAI mean scores at BL were 6.6 for OTEZLA 30 mg BID and 6.4 for placebo.

LOCF.

BASDAI, Bath Ankylosing Disease Activity Index; BID, twice daily; BL, baseline; LOCF, last observation carried forward; MCID, minimum clinically important difference; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

References:

  1. Mease PJ, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (156-week) improvements in BASDAI in psoriatic arthritis patients: pooled results from 3 phase III, randomized, controlled trials. Ann Rheum Dis. 2017;76 (suppl 2): Abstract FRI0512.
  2. Kviatkovsky MJ, Ramiro S, Landewé R, et al. The minimum clinically important improvement and patient-acceptable symptom state in the BASDAI and BASFI for patients with ankylosing spondylitis. J Rheumatol. 2016;43(9):1680-1686.
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