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OTEZLA has a proven long-term safety profile1,2

The long-term safety profile of OTEZLA was generally similar to that observed in clinical trials1,2

 

SERIOUS ADVERSE REACTIONS1-4

serious adverse reactions associated with otezla for psoriasis
a

Pooled data from ESTEEM 1 and ESTEEM 2. Includes all patients who received OTEZLA regardless of when OTEZLA exposure started. OTEZLA exposure is based on each patient’s total exposure to OTEZLA, defined as the time interval between the date of the first dose and the date of the last dose, inclusive.

b

Patients with a history of clinically significant cardiac disease and/or a finding of a clinically significant abnormality on 12-lead ECG at screening were excluded from the phase 3 PALACE and ESTEEM trials.

c

Patients with malignancy or a history of malignancy were excluded from the phase 3 PALACE and ESTEEM trials.

d

Patients with active TB infections were excluded from the phase 3 ESTEEM trials.

Over 3.5 years of treatment with OTEZLA

  • The rates of depression and suicidality were comparable to week 16 results1
  • No serious opportunistic infections or reactivation of tuberculosis infection were reported2*
*

Patients with active TB infections were excluded from the phase 3 ESTEEM trials.

ECG, electrocardiogram; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; Pt-Yrs, patient years.

References: 1. Reich K, Papp K, Gordon KB, et al. Long-term Safety and Tolerability of Apremilast in Patients With Psoriasis: Pooled Safety Analysis of Two Phase 3, Randomized, Controlled Trials (ESTEEM 1 and 2). Presented at: the 23rd Congress of the European Academy of Dermatology and Venereology; October 8-12, 2014; Amsterdam, the Netherlands. 2. Papp K, Sobell JM, Shah K, et al. Safety and Tolerability of Apremilast Up to 182 Weeks: Pooled Analyses From Phase 3 Clinical Trials. Presented at: the 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, DC. 3. Data on file, Celgene Corporation. 4. Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Long-term (156-Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Ar-thritis: Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials. Presented at: the Annual European Congress of Rheumatology EULAR 2016; 8–11 June 2016; London, UK.


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