Persistence of treatment with biologics for patients with psoriasis: a real‐world analysis of 16 545 biologic‐naïve patients from the French National Health Insurance database (SNIIRAM)

Sbidian, É.; Mezzarobba, M.; Weill, Alain; Coste, Joël; Rudant, Jérémie

doi:10.1111/bjd.16809

Cited by 52 publications

(80 citation statements)

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“…We also wanted to interpret the influence of the predictors (female sex, obesity, psoriatic arthritis) regardless of the choice of biologic. Female sex consistently predicted biologic discontinuation in the included studies for the biologics combined group, 15,17,18,[31][32][33][34] adalimumab alone 34,41 and etanercept alone (Fig. 2).…”

Section: Discussionmentioning

confidence: 94%

“…The predictive factors analysed in at least two studies were meta-analysed, leading to the inclusion of female sex, obesity and psoriatic arthritis in the pooled analysis. In total 13 cohort studies were included in the meta-analysis (n = 29 802): nine for female sex (n = 28 090), 15,17,18,[31][32][33][34][35][36] six for obesity (n = 9311) 15,17,31,[35][36][37] and six for psoriatic arthritis (n = 24 444) ( Fig. 1 and Tables S1 and S2; see Supporting Information).…”

Section: Study Selectionmentioning

confidence: 99%

“…1 and Tables S1 and S2; see Supporting Information). 3,15,17,33,35,36 Other factors contributing to treatment discontinuation that were noted in drug survival studies and included in this systematic review were smoking, 17 alcohol consumption, 15 metabolic syndrome, 3 biologic naivety, 20,36 younger patients, 38 lower body surface area 38 and higher Dermatology Life Quality Index (DLQI), 38 but these had insufficient data for pooled analysis.…”

Section: Study Selectionmentioning

confidence: 99%

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Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta‐analysis

et al. 2019

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Summary Background Long‐term therapy for psoriasis is impaired by gradual loss of effectiveness and treatment discontinuation. Identifying factors that affect biologic drug survival may help in treatment optimization. Objectives To identify factors that predicted biologic drug persistence or discontinuation in a real‐life setting. Methods We identified studies of biologic persistence in psoriasis through a comprehensive, systematic literature search using predefined search criteria. Studies were screened by title and abstract then further by full‐text review. Hazard ratio (HR) data were extracted for all available predictive factors (HRs > 1 denoted biologic discontinuation, and HRs < 1 denoted biologic persistence). A meta‐analysis of HRs (random‐effects model) was used to assess any predictive factor included in at least two studies. Results Sixteen cohort studies were included in the review, with a total of 32 194 patients. A meta‐analysis was performed on 13 studies (n = 29 802): nine for female sex (n = 28 090), six for obesity (n = 9311) and six for psoriatic arthritis (n = 24 444). Obesity and female sex predicted treatment discontinuation, with HRs of 1.21 [95% confidence interval (CI) 1.10–1.32, I2 = 0%] and 1.22 (95% CI 1.07–1.38, I2 = 84%), respectively. Concomitant psoriatic arthritis predicted biologic persistence (HR 0.83, 95% CI 0.80–0.86, I2 = 0%). Female sex predicted biologic discontinuation due to side‐effects, with a pooled HR of 2.16 (95% CI 1.39–3.35, I2 = 67%). Other reported predictive factors (smoking, metabolic syndrome, biologic naivety, age, Dermatology Life Quality Index, dyslipidaemia, high socioeconomic status and concomitant methotrexate) were insufficiently reported for meta‐analysis. Conclusions Our meta‐analysis demonstrates that female sex and obesity predict biologic discontinuation, and concomitant psoriatic arthritis predicts biologic survival. What's already known about this topic? Ineffectiveness is the main factor that causes drug discontinuation during long‐term treatment of psoriasis. It is unclear which factors and comorbidities impact drug persistence. What does this study add? Female sex and obesity predict biologic discontinuation due to ineffectiveness and adverse events. Concomitant psoriatic arthritis is associated with improved drug persistence.

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Section: Discussionmentioning

confidence: 94%

Section: Study Selectionmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

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Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta‐analysis

et al. 2019

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“…Our proxy definition of psoriasis was based on the prescription of at least two topical vitamin D derivatives. These drugs constitute the first‐line treatment for psoriasis, and our definition has been validated in a previous study . Furthermore, our study population had much the same characteristics as previously described populations of patients with severe psoriasis .…”

Section: Discussionmentioning

confidence: 95%

“…This parameter integrates effectiveness (as a treatment perceived as being ineffective; will not be continued) and safety (as a poorly tolerated treatment; is likely to be discontinued). The parameter is attracting growing interest in the field of dermatology, where most studies have looked at the persistence of treatment in patients with psoriasis treated only with biologics . Hence, the primary objective of the present study was to assess and compare the long‐term persistence of apremilast and methotrexate in the treatment of a large, exhaustive, nonselected population of patients with psoriasis in France.…”

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confidence: 99%

Persistence of apremilast in moderate‐to‐severe psoriasis: a real‐world analysis of 14 147 apremilast‐ and methotrexate‐naive patients in the French National Health Insurance database

et al. 2019

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Summary Background Real‐world data on the persistence of apremilast vs. methotrexate are inconclusive. Objectives To assess and compare the long‐term persistence of apremilast and methotrexate in a large cohort of patients with psoriasis. Methods All adult patients with psoriasis registered in the French national health insurance database (‘Système National des Données de Santé’) between 2009 and 2017 were eligible for inclusion. The study population comprised apremilast‐ and methotrexate‐naive patients, defined as those with a first prescription of apremilast or methotrexate. Levels of persistence were compared using a Cox model with propensity‐score matching that included potential confounders (notably age, sex, psoriatic arthritis, comorbidities and previous exposure to topical and systemic treatments). Results In this nationwide population‐based cohort, 14 147 adult patients with psoriasis (mean age 52·3 years, 55·2% male) were found to be naive to both apremilast and methotrexate. After propensity‐score matching, two subgroups of 4805 patients with similar baseline characteristics were included, of whom 3207 apremilast‐treated patients and 2736 methotrexate‐treated patients discontinued their treatment. Kaplan–Meier survival propensity‐score analyses revealed a discontinuation rate of 69% for apremilast and 59% for methotrexate in the first year of treatment. Apremilast‐treated patients had a higher risk of discontinuation than methotrexate‐treated patients when considering the study population as a whole (hazard ratio 1·28, 95% confidence interval 1·23–1·34) or in a propensity‐score‐matched analysis (hazard ratio 1·34, 95% confidence interval 1·27–1·41; P < 0·001). Conclusions Our real‐world data suggest that in the first year of treatment, the discontinuation rate was significantly higher for apremilast‐treated patients than for methotrexate‐treated patients, regardless of the previous therapeutic lines received. What's already known about this topic? Psoriasis is a common chronic, relapse–remitting, inflammatory skin disease associated with severe psychosocial impact. Apremilast, a phosphodiesterase 4 inhibitor, is one of the most recently commercialized psoriasis drugs. Little is known about the long‐term clinical effectiveness of apremilast. What does this study add? The discontinuation rate at 1 year for apremilast was 69%, compared with 58% for methotrexate, in a nationwide population‐based cohort including 14 147 nonselected adult patients with psoriasis. Patients in the apremilast cohort had a higher risk of discontinuation than patients in the methotrexate cohort using propensity‐score matching, including potentially relevant individual risk factors such as age, sex, comorbidities and psoriatic arthritis, and regardless of the previous therapeutic lines received. In daily practice, physicians should take these results into account when choosing between methotrexate and apremilast as a first‐line systemic therapy.

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Association Between Biologics Use and Risk of Serious Infection in Patients With Psoriasis

et al. 2021

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IMPORTANCE Biologics and targeted therapies, such as apremilast, are efficient treatments to manage moderate to severe psoriasis. More information about the risk of serious infection is needed for the newest treatment options in a real-world setting.OBJECTIVE To assess the risk of serious infection among biologics and apremilast used to treat psoriasis, with etanercept as the comparator. DESIGN, SETTING, AND PARTICIPANTSThis nationwide cohort study from France involved data from the National Health Data System covering approximately 99% of the French population. All adults with psoriasis, defined as receiving at least 2 prescriptions of a topical vitamin D derivative within a 2-year period, registered in the database between January 1, 2008, and May 31, 2019, were eligible. The study population included those who were new users of biologic agents or apremilast (ie, without any prescriptions of a biologic or apremilast during the previous year). Patients with HIV infection or a history of cancer, transplant, or serious infection were excluded. End of follow-up was January 31, 2020.MAIN OUTCOME MEASURES The primary end point was a serious infection in a time-to-event analysis using propensity score-weighted Cox proportional hazards regression models, estimating weighted hazard ratios (wHRs) and 95% CIs.RESULTS A total of 44 239 new users of biologic treatment were identified (mean [SD] age, 48.4 [13.8] years; 22 866 [51.7%] men; median follow-up, 12 months [interquartile range, 7-24 months]). A total of 29 618 (66.9%) were prescribed a tumor necrosis factor inhibitor first, 6658 (15.0%) an interleukin (IL) 12/23 inhibitor, 4093 (9.3%) an IL-17 inhibitor, 526 (1.2%) an IL-23 inhibitor, and 3344 (7.6%) apremilast. The total number of serious infections was 1656, and the overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1000 person-years. The most frequent serious infections were gastrointestinal infections (645 patients [38.9%]). After adjusting for time-dependent covariables, risk of serious infections was higher for new users of adalimumab (wHR, 1.22; 95% CI, 1.07-1.38) or infliximab (wHR, 1.79; 95% CI 1.49-2.16) vs etanercept, whereas ustekinumab was associated with a lower risk of having a serious infection (wHR, 0.79; 95% CI, 0.67-0.94). Risk of serious infections was not increased for new users of IL-17 and the IL-23 inhibitor guselkumab or apremilast vs etanercept. Risk of serious infections was increased with concomitant nonsteroidal anti-inflammatory drugs or systemic corticosteroids. CONCLUSIONS AND RELEVANCEIn this cohort study of individuals with moderate to severe psoriasis, risk of serious infections was increased in new users of infliximab and adalimumab vs etanercept, whereas ustekinumab users had lower risk of having a serious infection but not new users of IL-17 and IL-23 inhibitors or apremilast. Other observational studies are needed to confirm results for the most recent drugs.

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Persistence of treatment with biologics for patients with psoriasis: a real‐world analysis of 16 545 biologic‐naïve patients from the French National Health Insurance database (SNIIRAM)

Abstract: Our data suggest that biologics are less effective than physicians have been led to believe in a real-life, nonselected population. Further, long-term disease control requires several courses of different biologics.

Cited by 52 publications

References 27 publications

Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta‐analysis

Factors predicting persistence of biologic drugs in psoriasis: a systematic review and meta‐analysis

Persistence of apremilast in moderate‐to‐severe psoriasis: a real‐world analysis of 14 147 apremilast‐ and methotrexate‐naive patients in the French National Health Insurance database

Association Between Biologics Use and Risk of Serious Infection in Patients With Psoriasis

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