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OTEZLA REDUCES THE NUMBER OF TENDER AND SWOLLEN JOINTS1

Sustained reduction in tender and swollen joint count up to 5 years1,a

Line graph showing sustained reduction in tender and swollen joint count up to 5 years. Please see full Important Safety Information.

aPALACE 1 study. Data as observed; includes all patients who received OTEZLA 30 mg BID, regardless of whether they were initially randomized to OTEZLA 30 mg BID or placebo patients who were re-randomized to OTEZLA at week 16 or week 24. Randomized patients who received ≥1 dose of study medication: OTEZLA 30 mg BID, n = 497; placebo, n = 496. The n at each time point represents the number of patients with available data at the time point.

During the placebo-controlled phase, significantly greater reductions in TJC and SJC were achieved with OTEZLA 30 mg BID vs placebo at week 16 (TJC: -42.9% vs -7%, respectively; SJC: -50% vs -16.7%, respectively; P < 0.0001 for both).2*

Significantly more patients on OTEZLA achieved an ACR20 response vs placebo1,3

  • At week 16, more than twice as many patients treated with OTEZLA 30 mg BID achieved the primary endpoint of modified ACR20 vs placebo (64/161 [39.8%] vs 32/165 [19.4%]; P = 0.0001)
  • ACR20 response rates were sustained for up to 5 years in patients receiving OTEZLA 30mg BID

*PALACE 1-3 pooled analysis. Per-protocol population, LOCF.

PALACE 1 study. Per-protocol population, LOCF.

PALACE 1 study. Data as observed; includes all patients who received OTEZLA 30 mg BID, regardless of whether they were initially randomized to OTEZLA 30 mg BID or placebo patients who were re-randomized to OTEZLA at week 16 or week 24.

ACR, American College of Rheumatology; BID, twice daily; LOCF, last observation carried forward; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; SJC, swollen joint count; TJC, tender joint count.

References:

  1. Kavanaugh A, Gladman DD, Edwards CJ, et al. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis. Arthritis Res Ther. 2019;21(1):118.
  2. Cutolo M, Mease PJ, Gladman D, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (52-week) improvement in tender and swollen joint counts in patients with psoriatic arthritis: results from three phase 3, randomized, controlled trials. Presented at: the 2013 ACR/ARHP Annual Meeting; October 26-30, 2013; San Diego, CA. Abstract 317.
  3. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014;73(6):1020-1026.
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