Date: Sunday, November 5, 2017
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Apremilast (APR), an oral PDE4 inhibitor, was effective in phase 3, randomized, placebo (PBO)-controlled trials assessing treatment of moderate to severe plaque psoriasis (ESTEEM 1 and 2) and psoriatic arthritis (PsA; PALACE 1-3). We report MACE, malignancies, and serious infections (SIs; opportunistic and non-opportunistic) incidences in subjects receiving APR 30 mg BID (APR30) for ≥156 wks in a pooled analysis of these studies.
Methods: Incidence rates and exposure-adjusted incidence rates (EAIR)/100 subject-yrs of MACE, malignancies, SIs, and serious opportunistic infections (SOIs) are reported for 0 to 16 wks, 0 to ≤52 wks, and the APR-exposure period (0 to ≥156 wks) for subjects receiving APR30 any time during the studies, through February 2015; ~30% (n=575) of sbjs received >3 yrs (>156 wks) of APR exposure.
Results: 2,242 subjects were included in the safety analysis for 0 to 16 wks (PBO n=913, subject-yrs exposure [sy]=260.2; APR30 n=1,329, sy=377.8); 1,905 subjects received APR30 during the APR-exposure period, representing 3,527.5 sy. Exposure during 0 to ≤52 wks was 1,524.5 sy. At baseline, 64.2% of APR30 subjects with PsA (PALACE 1-3) were receiving concomitant DMARDs (including methotrexate). Incidence of MACE with APR30 was low and comparable to PBO during 0 to 16 wks. During 0 to ≤52 wks and the APR-exposure period, incidence of MACE (EAIR/100 subject-yrs) remained low (Table). Incidence rates (EAIR/100 subject-yrs) of hematologic malignancies, nonmelanoma skin cancers, and solid tumors were similar with PBO (0.0, 1.2, 0.4) and APR30 (0.0, 1.3, 0.3) during 0 to 16 wks; incidence rates remained low during 0 to ≤52 wks and the APR-exposure period (Table). During 0 to 16 wks, the overall rate of SIs and non-SIs was low and comparable between subjects receiving PBO (20.6%) and APR30 (24.8%). The overall rate of SIs and non-SIs was 42.2% during 0 to ≤52 wks and comparable to rates during the PBO-controlled period (0 to 16 wks); the majority of reported infections (upper respiratory tract infection, nasopharyngitis, sinusitis) were not serious. During the PBO-controlled period (0 to 16 wks), rates of SIs with APR30 were low and comparable to PBO; no SOIs were reported. During 0 to ≤52 wks, the overall rate of SIs was low (0.6%; EAIR/100 subject-yrs: 0.7). The rate of SIs remained low (1.8%; EAIR/100 subject-yrs: 1.0) during the long-term cumulative APR-exposure period (0 to ≥156 wks) (Table). No clustering of any particular event was noted with respect to SIs; most events occurred in only 1 subject. No clinical reactivation of tuberculosis was reported with long-term APR30 exposure (0 to ≥156 wks). The rate of marked hematologic abnormalities remained low with long-term APR exposure.
Conclusion: Incidence of MACE, malignancies, and SIs was low in subjects with psoriasis and PsA receiving APR30 for ≥156 wks. No new safety signals or SOIs were observed over time with APR30.
To cite this abstract in AMA style:Kavanaugh A, Augustin M, Lespessailles E, Papp KA, Paris M, Chen R, Gladman DD, Pariser DM, Peris K. Low Rates of Major Adverse Cardiac Events, Malignancies, and Serious Infections in Subjects with Psoriasis and Psoriatic Arthritis Treated with Apremilast for ≥156 Weeks: Pooled Analysis from the Esteem and Palace 1-3 Phase 3 Trials [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/low-rates-of-major-adverse-cardiac-events-malignancies-and-serious-infections-in-subjects-with-psoriasis-and-psoriatic-arthritis-treated-with-apremilast-for-%e2%89%a5156-weeks-pooled-analysis-from/. Accessed September 28, 2021.
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