4 results on '"Luigi Sinigaglia"'
Search Results
2. Assessment of patients affected by rheumatoid arthritis eligible for biotechnological agents and evaluation of their healthcare resource utilization and related costs
- Author
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Vittorio Perrone, Luigi Sinigaglia, L. Degli Esposti, and Diego Sangiorgi
- Subjects
rheumatoid arthritis ,real-world ,medicine.medical_specialty ,medicine.drug_class ,Biotechnological therapy ,Arthritis, Rheumatoid ,03 medical and health sciences ,Indirect costs ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Health care ,medicine ,Humans ,030212 general & internal medicine ,030203 arthritis & rheumatology ,business.industry ,medicine.disease ,RC31-1245 ,Methotrexate ,Treatment Outcome ,Lung disease ,under-treatment ,Rheumatoid arthritis ,Antirheumatic Agents ,Medicine ,Corticosteroid ,Drug Therapy, Combination ,Antirheumatic drugs ,business ,Delivery of Health Care ,Resource utilization ,medicine.drug - Abstract
Objective. To provide estimates of patients with rheumatoid arthritis (RA) eligible for biotechnological therapy and to evaluate their healthcare costs. Method. An observational analysis was performed based on data-linkage between administrative databases of selected Italian Regional/Local healthcare departments. Data were then re-proportioned to the Italian population. Patients with RA diagnosis defined by discharge diagnosis and/or exemption code during 01/01/2013- 31/12/2017 were included. The criteria applied to evaluate the elegibility for biotechnological therapy were: 1) methotrexate (MTX)-treatment failure ≥6 months and start of a different conventional-synthetic diseasemodifying antirheumatic drugs (csDMARD); 2) corticosteroid ≥6 months with dosage ≥7.5 mg/die; 3) MTX-contraindication (therapy or hospitalization for renal damage/interstizial lung disease/hepatic failure). Mean annual costs per patient included drugs, hospitalizations, outpatient services. Results. Data re-proportioned to the Italian population estimated 318,328 RA patients: 43,361 with, 274,967 without biotechnological agents. Among the latter, 26,487(9.6%) patients met ≥1 criteria applied for eligibility: 1,896 had MTX-treatment failure and started another csDMARD; 15,833 received corticosteroid ≥7.5 mg/die; 7,788 had MTX-contraindication. Regarding patients fulfilling two criteria, 107 had MTX-treatment failure followed by another csDMARDs and corticosteroid ≥7.5 mg/die, 53 were treated with another csDMARDs after MTX-treatment failure and also presented MTX-contraindication, 810 had corticosteroid ≥7.5 mg/die and MTX-contraindication. Mean total annual costs for patients estimated eligible for biotechnological therapy was € 3,132, of which € 177 related to drugs indicated for RA and € 2,955 related to other direct costs. Conclusions. According to our estimates, around 10% RA patients not currently treated with biotechnological agents are eligible for such therapies, highlighting a trend of under-use in clinical practice for RA management.
- Published
- 2020
3. [Italian consensus on the recommendations about the use of methotrexate for the treatment of rheumatic diseases with a focus on rheumatoid arthritis: results from the '3E initiative']
- Author
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G. F. Ferraccioli, Carlomaurizio Montecucco, F. De Leonardis, Eleonora Bonacci, Stefano Alivernini, Stefano Bombardieri, Francesco Trotta, Luigi Sinigaglia, Gabriele Valentini, AM Buono, De Leonardis, F, Alivernini, S, Bonacci, E, Buono, Am, Bombardieri, S, Ferraccioli, Gf, Montecucco, C, Sinigaglia, L, Trotta, F, and Valentini, Gabriele
- Subjects
lcsh:Internal medicine ,medicine.medical_specialty ,Consensus ,Delphi Technique ,Delphi method ,Alternative medicine ,MEDLINE ,lcsh:Medicine ,Cochrane Library ,Arthritis, Rheumatoid ,Rheumatology ,Meta-Analysis as Topic ,Rheumatic Diseases ,Medicine ,Humans ,Rheumatoid arthritis ,lcsh:RC31-1245 ,Meeting Abstracts ,business.industry ,lcsh:R ,Methotrexate ,Guideline ,Evidence-based medicine ,Italy ,Family medicine ,Antirheumatic Agents ,Practice Guidelines as Topic ,Physical therapy ,Controlled Clinical Trials as Topic ,business - Abstract
Objective: To develop a set of national evidence-based recommendations for the use of Methotrexate (MTX) in daily clinical practice. Methods: A panel of 37 Italian Rheumatologists reviewed 10 international recommendations formulated during the “3E (Evidence, Expertise, Exchange) initiative” for the year 2007-8, following a systematic literature search in Medline, Embase, Cochrane Library, and 2005-7 American College of Rheumatology/European League Against Rheumatism meeting abstracts and the revision of selected papers and the appraisal of Oxford levels of evidence. Moreover, the same panel by the same methodology formulated further 5 recommendations on topics previously selected by Italian representatives to 3E initiative. The agreement about the set of proposed recommendations was stated by a consensus process and the potential impact on clinical practice was assessed. Results: International Recommendations were analysed and changed when appropriate. In addition, 5 national recommendations were developed by identifying 6371 references, selecting and evaluating the 29 ones satisfying Evidence Based Medicine principles. Conclusions: A set of 15 national recommendations for the use of MTX in daily clinical practice was developed. These recommendations are evidence-based and integrate the expertise of a large panel of Italian rheumatologists.
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- 2010
4. [TNF- alpha gene polymorphisms in rheumatoid arthritis patients treated with anti-TNF-alpha agents: preliminary results]
- Author
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E. Di Poi, Martina Fabris, S. Sacco, Giuseppe Damante, G. F. Ferraccioli, and Luigi Sinigaglia
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Adult ,Male ,lcsh:Internal medicine ,Combination therapy ,Adolescent ,Genotype ,Drug Resistance ,lcsh:Medicine ,macromolecular substances ,Severity of Illness Index ,Serology ,Autoimmune Diseases ,Arthritis, Rheumatoid ,Rheumatology ,Medicine ,Humans ,Allele ,lcsh:RC31-1245 ,Gene ,Genotyping ,Alleles ,Aged ,Polymorphism, Genetic ,business.industry ,Tumor Necrosis Factor-alpha ,lcsh:R ,Antibodies, Monoclonal ,Middle Aged ,medicine.disease ,Infliximab ,Methotrexate ,Rheumatoid arthritis ,Antirheumatic Agents ,Immunology ,Tumor necrosis factor alpha ,Female ,business - Abstract
Objectives: To study –238 and +489 TNF-α polymorphisms in severe-unresponsive (more than 6 swollen joints and still active disease despite at least 6 months of DMARDs combination therapy) and mild-responsive (less than 3 swollen joints and good response to MTX or other conventional DMARDs) rheumatoid arthritis (RA). Methods: We investigated 100 RA patients (56 with severe and 44 with mild disease activity) and 45 healthy blood donors (HBDs). Genotyping was performed by PCR-restriction fragment lenght polymorphism procedure. Several clinical and serological parameters were also examined. Results: Severe RA patients disclosed the –238 GG genotype in 100% of the cases versus 95.5% in the mild-responsive patients and 91.2% in the HBDs. The +489 GG genotype disclosed only a trend towards a prevalence in severe RA patients. However the +489 A allele seems to associates with early onset, longer disease duration and longer responsiveness to conventional therapy. Conclusion: The -238 AG genotype is absent in severe-unresponsive RA, but present in mild-responsive RA subjects. Thus –238 GG homozygosity associates with severity and unresponsiveness. In contrast the +489 polymorphism does not segregate differently between responsive and unresponsive RA patients.
- Published
- 2002
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