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Significantly more patients on OTEZLA achieved an ACR20 response vs placebo1,2

 

ACR20 RESPONSE RATE AT WEEK 16 (PRIMARY ENDPOINT)3,a

acr20 response rates with otezla
all manifestations of psoriatic arthritis
a

PALACE 1 study. Full analysis set (FAS); subjects with missing values were treated as nonresponders. The FAS was the primary population for the analyses of efficacy during the placebo-controlled period (weeks 0-24). The FAS consisted of all subjects who were randomized as specified in the protocol. Subjects who were randomized in error and did not receive any dose of investigational product (IP) (OTEZLA or placebo) were excluded from the FAS; subjects who were randomized in error but did receive at least 1 dose of IP (OTEZLA or placebo) were to be included in the treatment group to which they were randomized. For the analyses using the FAS, subjects were included in the treatment group to which they were randomized, irrespective of the treatment they actually received.

  • 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)2*
  • ACR20 response rates were sustained for up to 3 years in patients receiving OTEZLA 30 mg BID1†
*

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; BL, baseline; LOCF, last observation carried forward; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

References: 1. Kavanaugh A, Gladman DD, Gomez-Reino JJ, et al. Presented at: the Annual European Congress of Rheumatology EULAR 2016; 8–11 June 2016; London, UK. 2016. 2. 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;73:1020–1026. 3. OTEZLA Summary of Product Characteristics. Celgene Europe, Ltd. Stockley Park, Uxbridge, UK.


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