Area Editoriale
Un analisi del database americano PharmMetrics dimostrerebbe che i pazienti trattati precocemente (entro 30 giorni dalla prima prescrizione farmacologica) con biologici presentano outcomes a lungo termine (uso di steroidi, perdita di risposta e necessità di chirurgia) più favorevoli rispetto sia ai pazienti trattati con la tradizionale strategia step-up, sia a quelli trattati precocemente con immunomodulatori. Oltre ai limiti delle analisi su database amministrativi ben discussi dagli autori, va notato che non è stata fatta alcuna stratificazione per comportamento di malattia; non è pertanto possibile definire se questi outcome più favorevoli si verificano anche per i pazienti con malattia luminale (per cui attualmente una strategia top-down non è universalmente raccomandata) o solo per quelli con malattia fistolizzante, per cui un uso precoce dei biologici è già fortemente raccomandato dalle linee-guida italiane di SIGE e IG-IBD. Inoltre, date anche le differenze significative ma numericamente non eclatanti negli outcome fra i due gruppi, sarebbe necessaria una accurata analisi dei costi prima di poter trarre conclusioni certe.
Response to biologic therapy in Crohn's disease is improved with early treatment: an analysis of health claims data.Rubin DT, Uluscu O, Sederman R. Inflamm Bowel Dis. 2012;18:2225-31.
BACKGROUND: Anti-tumor necrosis factor (TNF) therapy is an important treatment option for management of active Crohn's disease (CD) and is labeled for use after failure of conventional therapy (step-up). However, there is debate on the introduction of anti-TNF agents earlier in the treatment strategy (top-down) to potentially improve clinical outcomes. The aim of this study was to determine if a top-down approach with anti-TNF therapy is associated with improved outcomes for patients with active CD. METHODS: Claims data were from adult patients with CD with continuous enrollment in the same health plan for ≥ 6 months prior to the initial diagnostic claim for CD, < 12 months after their initial anti-TNF claim, and with ≥ 1 anti-TNF claims after their initial diagnosis for CD. RESULTS: Three patient groups were identified: The Step-Up group used 5-aminosalicylates and/or corticosteroids prior to anti-TNF; the immunosuppression (IS)-to-TNF inhibitor group used IS prior to anti-TNF therapy; the Early-TNF group initiated anti-TNF therapy within 30 days of the first prescription for CD. Response to anti-TNF therapy was determined up to 24 months following anti-TNF initiation by concomitant corticosteroid use, CD surgery, anti-TNF dose escalation, and anti-TNF discontinuation/switch. A top-down approach to anti-TNF therapy was associated with a lower risk of concomitant corticosteroid use, anti-TNF dose escalation, discontinuation/switch of anti-TNF, and CD-related surgery compared with the step-up and IS-to-TNF therapy approaches. CONCLUSIONS: These "real-world" data show that a top-down approach to anti-TNF therapy in CD is associated with reductions in loss of response and fewer surgeries than conventional step-wise management.