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1.
J Med Econ ; 25(1): 741-749, 2022.
Article in English | MEDLINE | ID: covidwho-1864882

ABSTRACT

AIMS: To compare long-term healthcare resource utilization (HCRU) and costs among patients who initiated ixekizumab (IXE) or adalimumab (ADA) for treatment of psoriasis in the United States. METHODS: Adult patients with psoriasis who had ≥1 claim for IXE or ADA were identified from IBM MarketScan claims databases prior to the COVID-19 pandemic (1 March 2016-31 October 2019). The index date was the date of first claim for the index drug of interest. Inverse probability of treatment weighting was employed to balance treatment cohorts. All-cause and psoriasis-related HCRU and costs were examined for 24 months of follow-up. Costs were reported as per patient per month. Costs of psoriasis-related biologics were adjusted using published Institute for Clinical and Economic Review (ICER) discount factors. Index drug costs were adjusted for adherence and ICER discount rates. RESULTS: The analyses included 407 IXE and 2,702 ADA users. IXE users had significantly higher inpatient admission rate (all-cause HCRU: 14.9% vs. 11.0%; p =0.012) and greater mean length of stay per admission (days, 6.6 vs. 4.1; p =0.004) than ADA users. ICER-adjusted costs were significantly higher in IXE than ADA users (all-cause costs: $4,132 vs. $3,610; p <0.001; psoriasis-related costs $3,077 vs. $2,700; p <0.001). After adjusting for ICER and adherence, IXE and ADA drug costs were comparable ($3,636 vs. $3,677; p =0.714). LIMITATIONS: Study relied on administrative claims data, subjected to data coding limitations and data entry errors. Rebates, patient assistance programs, and commission to wholesalers are not always captured in claims. Adjustment made by ICER discount factors may lead to double-discounting if the discounts have been applied in claim payments. CONCLUSIONS: All-cause HCRU was higher in IXE than ADA users. Healthcare costs were also higher in IXE than ADA users after ICER adjustment, over 24 months. Cost differences were largely driven by higher treatment adherence associated with IXE. Index drug costs were comparable after ICER and adherence adjustments.


Subject(s)
Antirheumatic Agents , COVID-19 , Psoriasis , Adalimumab/therapeutic use , Adult , Antibodies, Monoclonal, Humanized , Antirheumatic Agents/therapeutic use , Drug Costs , Follow-Up Studies , Health Care Costs , Humans , Pandemics , Psoriasis/drug therapy , Retrospective Studies , United States
4.
BMJ Case Rep ; 14(5)2021 May 06.
Article in English | MEDLINE | ID: covidwho-1457886

ABSTRACT

Although prednisolone, granulocyte/monocyte apheresis, calcineurin inhibitor and anti-tumour necrosis factor (TNF) therapy are generally used, no treatment strategy for inflammatory bowel disease complicated with pyoderma gangrenosum (PG) has been established yet. Herein, we present the case of a 29-year-old man with ulcerative colitis (UC) complicated with primary sclerosing cholangitis. When UC relapsed and PG developed, prednisolone and granulocyte/monocyte apheresis were used; however, their therapeutic effects were deemed insufficient. After 2 weeks, adalimumab (ADA) induced remission; however, his UC and PG relapsed 20 weeks later. As a result of switching to infliximab, since a loss of response to ADA was deemed to have occurred, remission was reintroduced and subsequently maintained for 40 weeks. We conclude that anti-TNF-α antibodies might be selected as the first choice when PG and UC are refractory to treatment, and a switch to anti-TNFs should be considered when the effect is still insufficient.


Subject(s)
Biological Products , Cholangitis, Sclerosing , Colitis, Ulcerative , Pyoderma Gangrenosum , Adalimumab/therapeutic use , Adult , Cholangitis, Sclerosing/complications , Cholangitis, Sclerosing/drug therapy , Colitis, Ulcerative/complications , Colitis, Ulcerative/drug therapy , Humans , Infliximab/therapeutic use , Male , Pyoderma Gangrenosum/complications , Pyoderma Gangrenosum/drug therapy , Tumor Necrosis Factor-alpha
5.
Cornea ; 40(9): 1204-1206, 2021 Sep 01.
Article in English | MEDLINE | ID: covidwho-1343730

ABSTRACT

PURPOSE: The purpose of this study was to report 2 patients with anterior scleritis manifesting after coronavirus disease 2019 (COVID-19). METHODS: The patients with confirmed COVID-19 developed anterior scleritis after their systemic symptoms were markedly improved. A thorough systemic workup identified no underlying autoimmune diseases. Ocular characteristics and safety and efficacy of systemic immunosuppressive therapy were evaluated. RESULTS: Case 1 was a 67-year-old woman who presented with necrotizing anterior scleritis in both eyes 3 weeks after the onset of COVID-19. One-week treatment with topical betamethasone and oral prednisolone (65 mg daily) did not result in improvement, so she was started on intravenous cyclophosphamide and subcutaneous adalimumab in addition to oral prednisolone. Necrotizing scleritis was gradually improved over 3 months. Case 2 was a 33-year-old man who presented with sectoral anterior scleritis in his right eye 2 weeks after the onset of COVID-19. He was started on topical betamethasone and oral prednisolone (85 mg daily). One week later, all signs and symptoms disappeared, and topical and oral corticosteroids were gradually tapered off over 2 weeks. There was no recurrence of respiratory symptoms or active scleritis in any cases after discontinuation of treatment. CONCLUSIONS: These cases suggest that COVID-19 can be associated with anterior scleritis, which responds to immunosuppressive and biologic agents. Ophthalmologists should consider anterior scleritis in patients with COVID-19 who present with ocular pain and redness during the convalescent phase of the illness.


Subject(s)
COVID-19/diagnosis , Eye Infections, Viral/diagnosis , SARS-CoV-2/isolation & purification , Scleritis/diagnosis , Adalimumab/therapeutic use , Adult , Aged , Anti-Inflammatory Agents/therapeutic use , COVID-19/drug therapy , COVID-19/virology , COVID-19 Nucleic Acid Testing , Cyclophosphamide/therapeutic use , Eye Infections, Viral/drug therapy , Eye Infections, Viral/virology , Female , Humans , Immunosuppressive Agents/therapeutic use , Infusions, Intravenous , Infusions, Subcutaneous , Male , Prednisolone/therapeutic use , SARS-CoV-2/genetics , Scleritis/drug therapy , Scleritis/virology
6.
J Crohns Colitis ; 16(2): 190-198, 2022 Feb 23.
Article in English | MEDLINE | ID: covidwho-1319160

ABSTRACT

BACKGROUND AND AIMS: Because of COVID-19 public health restrictions, telemedicine has replaced conventional outpatient follow up for most patients with chronic immune-mediated inflammatory disorders treated with biologic drugs. Innovative solutions to facilitate remote therapeutic drug monitoring are therefore required. Low-volume intracapillary blood sampling can be undertaken by patients at home and samples returned by post to central laboratories. We sought to report the effect of the COVID-19 pandemic on requests for therapeutic drug monitoring and the equivalence, acceptability and effectiveness of low volume Patient-led Remote IntraCapillary pharmacoKinetic Sampling [fingerPRICKS] compared to conventional venepuncture. METHODS: We undertook a cross-sectional blood sampling methods comparison study and compared sample types using linear regression models. Drug and antidrug antibody levels were measured using standard ELISAs. Acceptability was assessed using a purpose-designed questionnaire. RESULTS: Therapeutic drug monitoring requests for adalimumab (96.5 [70.5-106] per week to 52 [33.5-57.0], p < 0.001) but not infliximab (184.5 [161.2-214.2] to 161 [135-197.5], p = 0.34) reduced during the first UK stay-at-home lockdown compared with the preceding 6 months. Fingerprick sampling was equivalent to conventional venepuncture for adalimumab, infliximab, vedolizumab and ustekinumab drug, and anti-adalimumab and anti-infliximab antibody levels. The median [interquartile range] volume of serum obtained using intracapillary sampling was 195 µL [130-210]. More than 87% [90/103] of patients agreed that intracapillary testing was easy and 69% [71/103] preferred it to conventional venepuncture. In routine care, 75.3% [58/77] of patients returned two blood samples within 14 days to permit remote assessment of biologic therapeutic drug monitoring. CONCLUSIONS: Therapeutic drug monitoring can be undertaken using patient-led remote intracapillary blood sampling and has the potential to be a key adjunct to telemedicine in patients with immune-mediated inflammatory diseases.


Subject(s)
Drug Monitoring , Inflammatory Bowel Diseases , Self-Testing , Adalimumab/therapeutic use , COVID-19 , Cross-Sectional Studies , Drug Monitoring/methods , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Pandemics , SARS-CoV-2 , United Kingdom
7.
Int Immunopharmacol ; 99: 107961, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1300823

ABSTRACT

BACKGROUND: COVID-19, which is a disease caused by the SARS-CoV-2 virus, has spread around the world since late 2019. Studies have found associations between the rising levels of TNF-α and severe COVID-19 cases. Hence, TNF-α blocking can possibly be a favorable intervention in modifying COVID-19. To this end, in order to manage pneumonia caused by COVID-19, adalimumab may potentially be considered as a potential therapeutic agent. The present study aimed to investigate the potential therapeutic role of adalimumab in treating COVID-19 cases in combination therapy with remdesivir and dexamethasone. METHODS: Among the 68 patients who were included in the current randomized controlled trial, 34 were assigned to the adalimumab group and the remaining 34 were assigned to the control group. Adalimumab at a dose of 40 mg, subcutaneous for once, was used for the intervention group. Both the intervention and control groups received remdesivir, dexamethasone, and supportive care. The data gathered to make comparisons of the groups included demographic information, the rate of mortality, mechanical ventilation requirement, length of stay in hospital and Intensive Care Unit (ICU), and imaging findings. RESULTS: There was no significant difference between the two groups in the terms of mortality rate (P-value = 1) and mechanical ventilation requirement (P-value = 1). The length of hospital and ICU stay as well as radiologic changes were not affected either (P-value = 1, 0.27, and 0.53, respectively). CONCLUSIONS: Our findings did not support the use of adalimumab in combination with remdesivir and dexamethasone in the treatment of severe COVID-19 cases.


Subject(s)
Adalimumab/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Adult , Aged , Alanine/analogs & derivatives , Alanine/therapeutic use , Dexamethasone/therapeutic use , Drug Therapy, Combination , Female , Humans , Middle Aged , Pregnancy , Respiration, Artificial
8.
Exp Dermatol ; 30 Suppl 1: 18-22, 2021 06.
Article in English | MEDLINE | ID: covidwho-1258931

ABSTRACT

The reported incidence of COVID-19 among cohorts of patients with inflammatory bowel and skin diseases under treatment with biologicals is low. Treatment may further modify disease severity as some biological modifiers, such as anakinra, are also proposed for the management of COVID-19 patients potentially providing HS patients with an advantage. The above preliminary evidence suggests that hidradenitis suppurativa (HS) does probably not provide an increased susceptibility for COVID-19 and that any susceptibility is unlikely to be modified negatively by treatment with biologicals. On the occasion of its 10th International Conference, experts of the European Hidradenitis Suppurativa Foundation e.V. have prepared a consensus statement regarding anti-COVID-19 measurements for HS patients. Based on the available knowledge, patients with HS may be vaccinated against SARS-CoV2 and patients affected by metabolic syndrome constitute a high-risk group for COVID-19 and should be vaccinated at the earliest convenient point in time. HS patients on treatment with adalimumab can be vaccinated with non-living virus anti-SARS-CoV2 vaccines. A possible suboptimal effect of the vaccine may be suspected but might not be expected universally. The management of the biological treatment in HS patients is at the discretion of the dermatologist / responsible physician.


Subject(s)
COVID-19/complications , Hidradenitis Suppurativa/complications , Hidradenitis Suppurativa/drug therapy , SARS-CoV-2 , Adalimumab/therapeutic use , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/immunology , COVID-19 Vaccines/pharmacology , Cohort Studies , Disease Susceptibility , Europe , Foundations , Hidradenitis Suppurativa/immunology , Humans , Incidence , Interleukin 1 Receptor Antagonist Protein/therapeutic use , Metabolic Syndrome/complications , Metabolic Syndrome/immunology , Pandemics , Severity of Illness Index
11.
Dig Liver Dis ; 53(3): 277-282, 2021 03.
Article in English | MEDLINE | ID: covidwho-1009433

ABSTRACT

BACKGROUND: Patients receiving biologic therapies are at risk for viral infections. This study investigated the impact of the SARS-CoV-2 infection and the serum prevalence of SARS-CoV-2 antibodies in patients with inflammatory bowel disease (IBD) treated with biologic drugs. METHODS: Information on demography, co-morbidities, clinical data regarding IBD, symptoms suggestive of the SARS-CoV-2 infection, close contacts with SARS-CoV-2 positive patients, hospitalization, and therapies administered for COVID-19 was collected for all patients who were being treated with biologic drugs. All patients underwent SARS-CoV-2 antibody testing. RESULTS: Two hundred and fifty-nine patients (27 children) with a mean age of 42.2 ±â€¯16.7 years (range 9 - 88) and a mean duration of disease of 13.4 ±â€¯10 years (range 0.2 - 49) were enrolled. One hundred four patients (40.2%) had ulcerative colitis, and 155 (59.8%) had Crohn's disease. About the therapy: 62 patients were receiving infliximab, 89 adalimumab, 20 golimumab, 57 vedolizumab, 27 ustekinumab, 1 thalidomide, and 3 an experimental compound. The mean Charlson Comorbidity Index was 2. Thirty-two patients (12.3%) reported respiratory symptoms, and 2 of them were hospitalized (0.77%). Two patients resulted positive for IgG against SARS-CoV-2 (0.77%). CONCLUSIONS: In patients with IBD, treatment with biologic drug does not represent a risk factor for the SARS-CoV-2 infection.


Subject(s)
Biological Products/therapeutic use , COVID-19/epidemiology , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/epidemiology , Adalimumab/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Viral/immunology , COVID-19/immunology , COVID-19/physiopathology , COVID-19/therapy , COVID-19 Serological Testing , Child , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Enzyme-Linked Immunosorbent Assay , Female , Hospitalization , Humans , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Italy/epidemiology , Male , Middle Aged , SARS-CoV-2/immunology , Seroepidemiologic Studies , Thalidomide/therapeutic use , Ustekinumab/therapeutic use , Young Adult
16.
Rheumatol Int ; 40(9): 1423-1431, 2020 09.
Article in English | MEDLINE | ID: covidwho-641082

ABSTRACT

Concerns regarding the comorbidity as a significant risk factor for Coronavirus Disease-2019 (COVID-19), gave rise to an urgent need for studies evaluating patients with chronic conditions such as autoinflammatory diseases (AIDs). We prepared a web-based survey investigating the clinical findings and contact histories among pediatric patients with AIDs. Confirmed COVID-19 cases, patients with contact history and those with symptoms which were highly suggestive of COVID-19 were called via phone or recruited to a video or face to face appointment. Data of AIDs were obtained from their medical records, retrospectively. Laboratory and screening findings were confirmed by our national health registry website. There were 404 patients (217 female) eligible for the enrollment. During pandemic, 375 (93%) were on colchicine treatment and 48 (11.8%) were receiving biologic treatment. Twenty-four out of 404 patients were admitted to hospital due to COVID-19 suspicion. Severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) was identified through rhinopharyngeal swabs in seven patients, six of whom were only on colchicine treatment. Only one patient with no finding of any severe respiratory complications was hospitalized. All of seven patients recovered completely. Among patients on biologic drugs, neither a symptom nor a positive polymerase chain reaction test for COVID 19 was detected. In conclusion, pediatric patients with AIDs, those receiving biologic treatment and/or colchicine, may not be at increased risk for neither being infected nor the severe disease course.


Subject(s)
Colchicine/therapeutic use , Coronavirus Infections/physiopathology , Hereditary Autoinflammatory Diseases/drug therapy , Pneumonia, Viral/physiopathology , Tubulin Modulators/therapeutic use , Tumor Necrosis Factor Inhibitors/therapeutic use , Adalimumab/therapeutic use , Adolescent , Antibodies, Monoclonal, Humanized/therapeutic use , Betacoronavirus , Biological Products , COVID-19 , Child , Child, Preschool , Cohort Studies , Coronavirus Infections/complications , Coronavirus Infections/therapy , Cryopyrin-Associated Periodic Syndromes/complications , Cryopyrin-Associated Periodic Syndromes/drug therapy , Etanercept/therapeutic use , Familial Mediterranean Fever/complications , Familial Mediterranean Fever/drug therapy , Female , Hereditary Autoinflammatory Diseases/complications , Humans , Infant , Interleukin 1 Receptor Antagonist Protein/therapeutic use , Male , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/therapy , SARS-CoV-2 , Turkey , Young Adult
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