Adalimumab and infliximab survival in patients with hidradenitis suppurativa: a daily practice cohort study.
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ABSTRACT: Background
Biologics are often required for the treatment of hidradenitis suppurativa (HS). However, data on the drug survival of biologics in daily practice are currently lacking.Objectives
To assess the drug survival of antitumour necrosis factor biologics in a daily practice cohort of patients with HS and to identify predictors for drug survival.Methods
A retrospective multicentre study was performed in two academic dermatology centres in the Netherlands. Adult patients with HS using biologics between 2008 and 2020 were included. Drug survival was analysed with Kaplan-Meier survival curves and predictors of survival with univariate Cox regression analysis.Results
The overall drug survival of adalimumab (n = 104) at 12 and 24 months was 56·3% and 30·5%, respectively, which was predominantly determined by infectiveness. Older age (P = 0·02) and longer disease duration (P < 0·01) were associated with longer survival time. For infliximab (n = 44), overall drug survival was 58·3% and 48·6% at 12 and 24 months, respectively, and was predominantly determined by infectiveness and side-effects. Surgery during treatment was associated with a longer survival time (P = 0·01).Conclusions
Survival rates were comparable for adalimumab and infliximab at 12 months, and were mainly determined by ineffectiveness. Age, disease duration (adalimumab) and surgery (infliximab) are predictors for longer survival.
SUBMITTER: Prens LM
PROVIDER: S-EPMC8360014 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionPain is experienced by most patients with hidradenitis suppurativa (HS) and has a severe impact on their quality of life. Its management still presents a challenge. Adalimumab, a TNF-a antagonist, has shown promising results in HS-related pain reduction.ObjectivesTo aggregate and synthesize all existing evidence regarding the effect of adalimumab on HS-associated pain.MethodsWe identified original controlled and uncontrolled studies with participants receiving adalimumab, which included change in pain score post-treatment compared to baseline as an end-point. We searched MEDLINE, ScienceDirect, the Cochrane Library, ClinicalTrials.gov and International Clinical Trials Registry Platform. The primary endpoint of our study was the mean change (continuous variable) of pain scores at week 12 compared to baseline.ResultsWe performed a meta-analysis of 4 randomized controlled trials (282 patients in the intervention group and 266 patients in the control group). Adalimumab brought about a 0.418 reduction in mean pain score at its worst with 95%CI [-0.588, -0.248] and P = 0.000 at 12 weeks after treatment commencement. Four more studies were included in a qualitative synthesis, 2 of which reported statistically significant reduction in pain scores at week 12.ConclusionsAdalimumab could be prescribed more readily in cases of HS associated with significant pain.
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Project description:IntroductionCohort studies on the use of retinoids for hidradenitis suppurativa (HS) have yielded contradicting results. As the clinical presentation of HS is heterogeneous, with different predilection sites and hallmark features, it can be hypothesized that HS phenotypes are associated with the effectiveness of specific retinoid treatments.ObjectivesThe aim of this study was to evaluate the drug survival of oral retinoids in the treatment of HS and to establish predictors for longer treatment duration.MethodsA retrospective, dual-center study was conducted in the Netherlands in adult HS patients treated with oral retinoids between 2011 and 2021. Drug survival analyses were performed through Kaplan-Meier survival curves. Additionally, Cox regression models were used to determine predictors for a longer drug survival.ResultsIn total, 102 patients were included. Overall drug survival of (low-dose) isotretinoin (n = 66) at 12 and 24 months was 44.2% and 15.5%, respectively. Termination of treatment was mostly due to ineffectiveness (26%). Presence of widespread comedones (p = 0.03) and the use of concomitant systemic medication (p = 0.04) were associated with a prolonged treatment duration. For acitretin (n = 36), the overall drug survival was 42.0% at 12 months and 37.4% at 24 months, and was also predominantly determined by ineffectiveness (28%). Interestingly, the scarring folliculitis phenotype (p < 0.05) was associated with prolonged drug survival time for acitretin treatment relative to the regular phenotype.ConclusionComparable drug survival rates at 12 months for isotretinoin and acitretin were found. HS patients with widespread comedones and the scarring folliculitis phenotype could benefit from treatment with isotretinoin or acitretin, respectively.
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Project description:BackgroundDetermining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations.ObjectiveEvaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility as an outcome measure.MethodsPatients with baseline total abscess and inflammatory nodule count (AN count) of at least three and draining fistula count of 20 or fewer comprised the post hoc subpopulation analysed. HiSCR (at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline) and HS-PGA Response [Hidradenitis Suppurativa-Physician's Global Assessment score of clear, minimal, or mild, with at least a 2-grade improvement from baseline] were used to evaluate patient response after adalimumab treatment weekly, every other week, or placebo (1 : 1 : 1).ResultsThe subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, HiSCR was achieved by 54.5% receiving weekly adalimumab, 33.3% every other week, and 25.6% placebo and HS-PGA Response was achieved by 20.5% receiving weekly adalimumab, 6.7% every other week and 2.3% placebo.ConclusionHiSCR was more responsive to change than HS-PGA Response in this subpopulation.
| S-EPMC5034809 | biostudies-literature
Project description:BackgroundLong-term, real-word data are needed to help manage patients with hidradenitis suppurativa (HS) through this recurrent, painful and debilitating disease.ObjectivesTo primarily measure real-world effectiveness of adalimumab in HS and to secondarily observe clinical course of HS in the light of patients' response.MethodsIn SOLACE, adults with moderate-to-severe HS in need for change in ongoing therapy were treated with adalimumab for up to 52 weeks as per physician's medical practice. Treatment effectiveness was measured by Hidradenitis Suppurativa Clinical Response (HiSCR). Inflammatory nodules, abscesses and draining fistulas were counted, Hurley stage was assessed, and disease severity was rated using the International HS Severity Scoring System (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at baseline (low, medium and high) and gender. Spontaneously reported safety events were collected.ResultsFrom 23 Canadian centres, 69% of the 138 patients achieved HiSCR at week 24, which increased to 82% and 75% at week 52 in patients with medium and high AN counts, respectively. Gender (4 times the odds for female) and age at HS onset (5% decrease with each additional year) had an effect on achieving HiSCR. Treatment with adalimumab led to an important decrease in number of lesions in responders, with most gains observed in inflammatory nodules, more frequently in the lower body area of patients in the high AN count group. The IHS4 scores of responders were substantially lowered, with a larger decrease in patients of the high AN count group. No new safety signal was detected.ConclusionsThe effectiveness of adalimumab was maintained during this 1-year period, and an optimal gain was documented for patients with medium and high AN counts. These real-world data support a prompt treatment of HS patients and the use of IHS4 to monitor treatment.
| S-EPMC9291024 | biostudies-literature
Project description:BackgroundHidradenitis suppurativa (HS), a chronic, recurrent, debilitating skin disease, is characterized by painful, inflammatory, subcutaneous lesions of the axilla, inguinal and anogenital regions. Overall prevalence of HS is ˜1%, and the impact of disease on patient quality of life (QoL) and healthcare resource utilization (HRU) is high.ObjectivesTo estimate the real-world effectiveness of adalimumab (Humira®) treatment in patients with moderate-to-severe HS on disease severity, pain, QoL, work productivity and HRU.MethodsHARMONY (Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi-cOuNtry studY in Real Life Setting) is a multicentre, postmarketing observational study in adult patients with moderate-to-severe HS. Disease severity and QoL parameters were evaluated using validated measures at 12-week intervals over 52 weeks of treatment. The primary endpoint was the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction in abscess and inflammatory nodule count, with no increase in abscess and draining fistula counts relative to baseline) at 12 weeks. Secondary endpoints were HiSCR at 24, 36 and 52 weeks and changes in QoL parameters and work productivity assessments. Analyses were conducted using as-observed data.ResultsThe proportion of patients reaching the primary HiSCR endpoint was 70.2% (n = 132/188 enrolled) and remained ≥70% until study completion. There were statistically significant (P < 0.0001) reductions in worst and average skin pain. All of the QoL measures evaluated improved significantly (P < 0.0001) by 12 weeks of adalimumab treatment, as did work productivity assessments (P < 0.05), and there was a ˜50% decrease in HRU between baseline and week 52. Adalimumab was well tolerated.ConclusionsIn this real-world setting, adalimumab treatment of moderate-to-severe HS resulted in decreased disease severity and improvements in QoL and productivity. Response to adalimumab was rapid (within 12 weeks) and sustained (52 weeks). No unexpected safety signals were reported.
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Project description:BackgroundThe European hidradenitis suppurativa (HS) guidelines recommend a multidisciplinary approach for patients with HS and management of comorbidities.ObjectiveWe aimed to describe the organization of a multidisciplinary HS program and characterize the patient population.MethodsWe conducted a retrospective study of patients with HS undergoing prospectively defined multidisciplinary work-up including examinations by a dermatologist, plastic surgeon, smoking specialist, and nutritionist in our outpatient unit between October 2015 and January 2017.ResultsThe study included 49 patients with a sex ratio of 1:1. A total of 73.4% of patients were smokers, 20.4% were overweight, 48.9% were obese, and 30.6% had symptoms of depression. The mean Sartorius score was 30.4 (±17.6). The outcome of plastic surgery consultation was as follows: 16 patients had operations, 5 were excluded based on medical history, 9 refused surgery, and 16 remained undecided. The refusal rates for consulting with the smoking cessation and nutrition specialists were 55.8% and 69.5%, respectively. Twelve patients received antibiotics, 9 received biologics, 9 underwent medico-surgical treatment, 9 underwent surgery, and 10 were lost to follow-up. The mean visual analogue scale score for satisfaction was 8.3 (±1.6; n = 28).ConclusionAn integrated multidisciplinary care model for HS is associated with high patient satisfaction. Adherence to the proposed comorbidity management was higher in female patients and related to empathetic interactions with physicians.
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Project description:Background:Hidradenitis suppurativa is a chronic inflammatory skin disorder associated with inflammatory bowel disease. However, it can arise as a paradoxical side effect of anti-TNF treatment. Methods:The article reports on three patients with Crohn's disease who developed hidradenitis suppurativa during the treatment with adalimumab. Results:Case 1: A 38-year-old female exhibited an infiltrative lesion in the inguinal region and vulva, consistent with hidradenitis suppurativa, after three months of adalimumab. These lesions were treated with partial vulvectomy. Case 2: After adalimumab treatment, a 27-year-old female, originally diagnosed with ileocolonic Crohn's disease, went into clinical and endoscopic remission. The patient eventually presented two hyperchromic nodules in the inguinal region, which were diagnosed as hidradenitis suppurativa. The patient showed improvement after treatment with oral doxycycline and local therapy. Case 3: A 34-year-old female with fistulizing and stenosing ileocolonic Crohn's disease, started adalimumab in 2010, with optimization in 2015. One year after, the patient developed bilateral, erythematous, hardened, inguinal nodulations with purulent drainage, consistent with hidradenitis suppurativa. Treatment with oral doxycycline, fusidic acid, and infiltration with triamcinolone resulted in partial improvement of the lesions. In 2018, the lesions deteriorate. The patient underwent surgical treatment. Conclusion:Patients with inflammatory bowel disease are more likely to the development of other mediated inflammatory diseases, such as hidradenitis suppurativa. Hidradenitis suppurativa may appear as a paradoxical reaction to anti-TNF therapy. Clinical teams must be aware of this type of complication. Early diagnosis and treatment are essential for controlling the disease and preventing the onset of complications.
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Project description:IntroductionHidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval.MethodsThis non-interventional, retrospective cohort study involved adult (≥ 18 years) and adolescent (12-17 years) patients diagnosed with HS in the United States (US) using Optum's de-identified Clinformatics® Data Mart Database during the period 1 January 2016 to 31 December 2018.ResultsOf 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patients aged <12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6%; adolescents: 39.6%) or dermatologist (adults: 22.1%; adolescents: 30.6%). Commonly reported Charlson comorbidities at pre-index in adult patients were diabetes without complications (20.4%), chronic pulmonary disease (16.4%) and diabetes with complications (9.0%), and the most frequent Elixhauser comorbidities were uncomplicated hypertension (38.3%), obesity (22.5%), uncomplicated diabetes (19.0%) and depression (17.4%). The burden of comorbidities generally increased over time after diagnosis in both adults and adolescents. HS-related surgical procedures were uncommon in the 2-years post-index period: an incision and drainage procedure was reported in 7.6% of adults and 6.4% of adolescents. Patients were predominantly treated with both topical and systemic antibiotic treatments (adults: 25.0% and 65.1%, respectively; adolescents: 41.7% and 74.5%, respectively). Biologic prescription was higher in adults than adolescents (3.5% vs. 1.8%). Total healthcare costs for adult and adolescent patients in the 2-years post-index period were US$42,143 and US$16,057, respectively, with outpatient costs accounting for the majority of these costs (US$20,980 and US$8408, respectively).ConclusionIn adult and adolescent patients with HS, comorbidity burden continues to increase after diagnosis. All-cause and HS-specific HCRU and costs are high in adults and adolescents with HS. These findings support the need for a multidisciplinary comprehensive care strategy for patients with HS.
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Project description:Altered gut microbiota composition has been observed in individuals with hidradenitis suppurutiva (HS) and many other inflammatory diseases, including obesity, type 1 and type 2 diabetes. Here, we addressed whether adalimumab, a systemic anti-inflammatory therapy, may impact the microbiota biochemical profile, particularly on beneficial metabolites such as short-chain fatty acids (SCFAs). We conducted an observational single-arm pilot trial to assess gut microbiota composition by 16S rRNA gene sequence analysis and to detect metabolite signatures by gas chromatography in stool samples from participants with HS prior to and 12 weeks after commencing adalimumab therapy. HS individuals that better responded to adalimumab treatment showed a shift in the composition and function of the gut microbiota with significantly increased SCFA acetate and propionate compared to age, gender and BMI-matched healthy controls. A positive correlation was observed between propionate with Prevotella sp and Faecalibacterium prausnitsii. Increased SCFAs, changes in gut microbiota composition, function and metabolic profile following 12 weeks of adalimumab suggest that targeting SCFAs may be considered a potential biomarker to be evaluated as a complementary protective factor or as a diagnostically relevant signal in HS.
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Project description:Elevated BMI in Hidradenitis Suppurativa is associated with decreased response to Adalimumab therapy. BMI is proposed to segregate distinct disease subtypes. It remains unresolved whether a threshold BMI exists above which increased dosages may provide clinical benefit. Individual patient data from 578 PIONEER Phase 3 participants were analyzed. Descriptive, multivariable regression analysis and receiver operating characteristic (ROC) curves were calculated to assess the relationship between BMI and clinical outcome measures using R v3.5.3. Participants in the overweight and obese BMI category had reduced odds (58 and 67%, respectively) of achieving HiSCR [OR = 0.42 (95%CI -0.19, 0.91) p = 0.03], [OR = 0.33 (95%CI 0.16, 0.67) p = 0.002] compared to participants with BMI < 25. Reduction in AN count and IHS4 score was not significantly associated. ROC analysis did not reveal any cut off value predictive of treatment outcome. No correlation between BMI and baseline disease activity or covariate interactions were identified. These findings suggest BMI is a significant covariate in the setting of lower baseline disease activity, supporting the concept of disease heterogeneity and differential therapeutic response to Adalimumab.
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