Dataset Information

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink.

ABSTRACT:

Introduction

This real-world safety analysis was requested by the European Medicines Agency following approval of apremilast, an oral treatment for psoriasis or psoriatic arthritis.

Objective

We aimed to compare incidence rates of adverse events of special interest identified a priori, in patients receiving apremilast with those receiving other systemic treatments for psoriasis or psoriatic arthritis.

Methods

This 5-year cohort study was conducted in Clinical Practice Research Datalink GOLD between January 2015 and June 2020. Incidence rates of adverse events of special interest were estimated for four matched cohorts: apremilast-exposed and three matched non-apremilast cohorts (oral only, injectable only, and oral and injectable psoriasis or psoriatic arthritis treatments).

Results

The apremilast-exposed cohort included 341 patients and the three non-apremilast cohorts included 4981 patients. There were no incident cases of vasculitis, hematologic malignancy, non-melanoma skin malignancy, treated depression, treated anxiety, or suicidal behaviors in the apremilast-exposed cohort during the follow-up. Similar incidence rates of all-cause mortality, major adverse cardiac events, tachyarrhythmias, and solid malignancies were recorded in the apremilast and non-apremilast cohorts. The incidence rate (95% confidence interval) per 1000 person-years of opportunistic and serious infections in the apremilast-exposed cohort (64 [40-102])) was similar to incidence rates in the oral (50 [42-60]) and oral and injectable non-apremilast cohorts (57 [47-69]), while the incidence rates were lower in the injectable treatment-only cohort (20 [10-41]). Limitations include small numbers of apremilast-exposed patients and potential exposure misclassification partly owing to missing information on biologic and other specialty treatment use.

Conclusions

No new apremilast safety signals were identified in this study. These results provide evidence that the long-term safety of apremilast in psoriasis and psoriatic arthritis in a real-world setting is comparable to that reported in clinical trials.

SUBMITTER: Persson R

PROVIDER: S-EPMC9510500 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink.

Persson Rebecca R Cordey Myriam M Paris Maria M Jick Susan S

Drug safety 20220923 11

<h4>Introduction</h4>This real-world safety analysis was requested by the European Medicines Agency following approval of apremilast, an oral treatment for psoriasis or psoriatic arthritis.<h4>Objective</h4>We aimed to compare incidence rates of adverse events of special interest identified a priori, in patients receiving apremilast with those receiving other systemic treatments for psoriasis or psoriatic arthritis.<h4>Methods</h4>This 5-year cohort study was conducted in Clinical Practice Resea ...[more]

PMID: 36151359

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Project description:Study questionWhat is the prevalence of different types of potentially hazardous prescribing in general practice in the United Kingdom, and what is the variation between practices?MethodsA cross sectional study included all adult patients potentially at risk of a prescribing or monitoring error defined by a combination of diagnoses and prescriptions in 526 general practices contributing to the Clinical Practice Research Datalink (CPRD) up to 1 April 2013. Primary outcomes were the prevalence of potentially hazardous prescriptions of anticoagulants, anti-platelets, NSAIDs, β blockers, glitazones, metformin, digoxin, antipsychotics, combined hormonal contraceptives, and oestrogens and monitoring by blood test less frequently than recommended for patients with repeated prescriptions of angiotensin converting enzyme inhibitors and loop diuretics, amiodarone, methotrexate, lithium, or warfarin.Study answer and limitations49 927 of 949 552 patients at risk triggered at least one prescribing indicator (5.26%, 95% confidence interval 5.21% to 5.30%) and 21 501 of 182 721 (11.8%, 11.6% to 11.9%) triggered at least one monitoring indicator. The prevalence of different types of potentially hazardous prescribing ranged from almost zero to 10.2%, and for inadequate monitoring ranged from 10.4% to 41.9%. Older patients and those prescribed multiple repeat medications had significantly higher risks of triggering a prescribing indicator whereas younger patients with fewer repeat prescriptions had significantly higher risk of triggering a monitoring indicator. There was high variation between practices for some indicators. Though prescribing safety indicators describe prescribing patterns that can increase the risk of harm to the patient and should generally be avoided, there will always be exceptions where the indicator is clinically justified. Furthermore there is the possibility that some information is not captured by CPRD for some practices-for example, INR results in patients receiving warfarin.What this study addsThe high prevalence for certain indicators emphasises existing prescribing risks and the need for their appropriate consideration within primary care, particularly for older patients and those taking multiple medications. The high variation between practices indicates potential for improvement through targeted practice level intervention.Funding, competing interests, data sharingNational Institute for Health Research through the Greater Manchester Primary Care Patient Safety Translational Research Centre (grant No GMPSTRC-2012-1). Data from CPRD cannot be shared because of licensing restrictions.

Project description:BackgroundSince US FDA approval in 2014, apremilast has consistently demonstrated a favorable benefit-risk profile in 706,585 patients (557,379 patient-years of exposure) worldwide across approved indications of plaque psoriasis, psoriatic arthritis, and Behçet's syndrome; however, long-term exposure across these indications has not been reported.ObjectiveThe aim of this study was to conduct a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety.MethodsWe analyzed longer-term safety and tolerability of apremilast 30 mg twice daily across three indications for up to 5 years, focusing on adverse events of special interest, including thrombotic events, malignancies, major adverse cardiac events (MACE), serious infections, and depression. Data were pooled across 15 randomized, placebo-controlled studies and divided into placebo-controlled or all-apremilast-exposure groups. Treatment-emergent adverse events (TEAEs) were assessed.ResultsOverall, 4183 patients were exposed to apremilast (6788 patient-years). Most TEAEs were mild to moderate in the placebo-controlled period (96.6%) and throughout all apremilast exposure (91.6%). TEAE rates of special interest were similar between treatment groups in the placebo-controlled period and remained low throughout all apremilast exposure. Exposure-adjusted incidence rates per 100 patient-years during all apremilast exposure were MACE, 0.30; thrombotic events, 0.10; malignancies, 1.0; serious infections, 1.10; serious opportunistic infections, 0.21; and depression, 1.78. Safety findings were consistent across indications and regions. No new safety signals were identified.ConclusionsThe incidence of serious TEAEs and TEAEs of special interest was low despite long-term exposure, further establishing apremilast as a safe oral option for long-term use across indications with a favorable benefit-risk profile.Clinical trial registrationNCT00773734, NCT01194219, NCT01232283, NCT01690299, NCT01988103, NCT02425826, NCT03123471, NCT03721172, NCT01172938, NCT01212757, NCT01212770, NCT01307423, NCT01925768, NCT00866359, NCT02307513.

Dataset Information

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink.

Introduction

Objective

Methods

Results

Conclusions

Publications

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink.

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