Apremilast and suicidality – a retrospective analysis of three large databases: the FAERS, EudraVigilance and a large single‐centre US patient population

Vakharia, Paras P.; Orrell, Kelsey A.; Lee, D.; Rangel, Stephanie M.; Lund, E.; Laumann, Anne E.; West, Dennis P.; Nardone, Beatrice

doi:10.1111/jdv.14256

Cited by 9 publications

(3 citation statements)

References 6 publications

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“…Although gastrointestinal side effects represented the leading symptom motivating discontinuation in our cohort, two patients (4%) interrupted apremilast because of suicidal ideation. This serious AE has been consistently reported in post-marketing surveillance and continued pharmacovigilance is warranted ( 31 ). Upper respiratory tract infection has been the most reported infection in association to apremilast.…”

Section: Discussionmentioning

confidence: 92%

Apremilast in Refractory Behçet’s Syndrome: A Multicenter Observational Study

et al. 2021

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ObjectiveMucocutaneous and joint disorders are the most common manifestations in Behçet’s syndrome (BS) and are frequently clustered in the so-called minor forms of BS. There remains a need for safe and effective treatment for joint lesions in BS. We report the long-term safety and effectiveness of apremilast in refractory joint and mucocutaneous manifestations of BS.MethodsFrench nationwide multicenter study including 50 BS patients with either active joint and/or mucocutaneous manifestations resistant to colchicine and/or DMARDs. Patients received apremilast 30 mg twice a day. Primary effectiveness endpoint was the proportion of patients with complete response (CR) of articular symptoms at month 6 (M6), defined as resolution of inflammatory arthralgia and arthritis, with joint count equal to zero.ResultsAt inclusion, the median tender and swollen joint count was of 4 [2-6] and 2 [1-2], respectively. The proportion of CR in joint disease at M6 was 65% (n = 15/23), and 17% (n = 4/23) were partial responders. CR of oral and genital ulcers, and pseudofolliculitis at M6 was 73% (n = 24/33), 94% (n = 16/17) and 71% (n = 10/14), respectively. The overall response at M6 was 74% for the entire cohort and 70% for the mucocutaneous-articular cluster (n = 27). The median Behçet’s syndrome activity score significantly decreased during study period [50 (40–60) vs. 20 (0–40); p <0.0001]. After a median follow-up of 11 [6-13] months, 27 (54%) patients were still on apremilast. Reasons for apremilast withdrawal included adverse events (n = 15, 30%) and treatment failure (n = 8, 16%). Thirty-three (66%) patients experienced adverse events, mostly diarrhea (n = 19, 38%), nausea (n = 17, 34%) and headache (n = 16, 32%).ConclusionApremilast seems effective in BS-related articular disease refractory to colchicine and DMARDs. Discontinuation rates were significantly higher than that reported in clinical trials.

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Section: Discussionmentioning

confidence: 92%

Apremilast in Refractory Behçet’s Syndrome: A Multicenter Observational Study

et al. 2021

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“…A PubMed search identified several previously reported unusual side effects of apremilast such as severe bitter taste, chronic diarrhea with malnutrition, cutaneous hyperpigmentation, chronic tearing, recurrence of melanoma and purpura annularis telangiectodes of Majocchi [11-16]. An association with an elevated suicidality risk was also found during the clinical trials [17].…”

Section: Discussionmentioning

confidence: 99%

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast

Ntouniadakis

Landström

2020

Case Rep Dermatol

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Apremilast (Otezla®) is a relatively novel orally administered non-biologic disease-modifying anti-rheumatic drug (DMARD) extensively used in the management of psoriasis and psoriasis arthritis, lately approved for treating oral ulcerations in Behçets disease. Its advantageous side effect profile together with its uncomplicated follow-up and monitoring when compared to other DMARDs facilitates even a broad off-label prescribing. Here, the first case of laryngeal pseudotumor in a patient treated with apremilast for plaque psoriasis is presented.

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“…The US FDA Adverse Event Reporting System (FAERS) is a consolidated pharmacovigilance database gathering worldwide spontaneous reports of adverse events and medication errors following drug administration. It is employed to investigate unexpected drug reactions and it was recently explored to investigate drug misuse and abuse, including DSP [ 29 ], suicide ideation as an adverse reaction [ 30 – 32 ], and suicide prodromes [ 33 ]. We aimed to investigate its potential use as a complementary source to characterize the DSP phenomenon, including both fatal and non-fatal cases, with a particular focus on risk factors, temporal trends, medications used, toxidromes and LDs.…”

Section: Introductionmentioning

confidence: 99%

Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System

et al. 2023

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Introduction Deliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is hampered by limited sample sizes and data reliability. We investigate the role of the US FDA Adverse Event Reporting System (FAERS), a consolidated pharmacovigilance database, in outlining DSP habits and toxidromes. Methods We retrieved cases of ‘intentional overdose’ and ‘poisoning deliberate’ from the FAERS (January 2004–December 2021). Using descriptive and disproportionality analyses, we estimated temporal trends, potential risk factors, toxidromes, case-fatality rates and lethal doses (LDs) for the most frequently reported drugs. Results We retrieved 42,103 DSP cases (17% fatal). Most cases were submitted in winter. Reports of DSP involved younger people, psychiatric conditions, and alcohol use, compared with non-DSP, and fatality was higher in men and older patients. Suspected drugs were mainly antidepressants, analgesics, and antipsychotics. Multiple drug intake was recorded in more than 50% of the reports, especially analgesics, psychotropics, and cardiovascular agents. The most frequently reported drugs were paracetamol, promethazine, amlodipine, quetiapine, and metformin. We estimated LD25 for paracetamol (150 g). Conclusion Worldwide coverage of the FAERS complements existing knowledge about DSP and may drive tailored prevention measures to timely address the DSP phenomenon and prevent intentional suicides. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-022-01269-x.

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Apremilast and suicidality – a retrospective analysis of three large databases: the FAERS, EudraVigilance and a large single‐centre US patient population

Cited by 9 publications

References 6 publications

Apremilast in Refractory Behçet’s Syndrome: A Multicenter Observational Study

Apremilast in Refractory Behçet’s Syndrome: A Multicenter Observational Study

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast

Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System

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