PTU-069 Effect of Adalimumab on Patients with Moderate to Severe Ulcerative Colitis in UK Clinical Practice Setting: Results from Inspirada
Notice bibliographique
Résumé
Introduction Limited real world data are available regarding the effects of adalimumab (ADA) on UK patients with moderate to severe ulcerative colitis (UC). Methods INSPIRADA was a single-arm, multi-country, open-label study that evaluated the effect of ADA on patients with UC treated according to usual clinical practice. Adults with active moderate to severe UC who failed immunosuppressive therapies and experienced rectal bleeding within 7 days of baseline (BL) were enrolled. Prior use of anti-TNF was allowed. Clinical outcomes included Simple Clinical Colitis Activity Index (SCCAI) response (a decrease ≥2 points compared to BL) and remission (SCCAI ≤2). HRQoL (EQ-5D-5L and SIBDQ), treatment satisfaction with medication (TSQM), and work productivity and activity impairment (WPAI) were measured from BL to week 26. Direct medical costs (excluding ADA costs) were estimated using 2014 UK National Health Service reference costs. Indirect costs were based on the WPAI using average weekly earnings from the 2014 UK Annual Salary Survey of Hours and Earnings. Change (defined as 6 mo after start of ADA vs 6 mo before) in resource use and costs were calculated. Data for the intent-to-treat population in UK were analysed. Missing data were imputed using last observation carried forward. Results Data from 90 UK patients (58% male, mean age 39 yrs) were analysed. Mean SCCAI at BL was 8.2. At week 2, 74% achieved SCCAI response and 21% achieved SCCAI remission. At week 8, 73% achieved SCCAI response, 40% in remission and 49% had no blood in stool. At week 26, 66% achieved SCCAI response, 42% in remission and 51% had no blood in stool. Significant improvements, as early as within 2 weeks, in SIBDQ (19.5 points, p < 0.001), EQ-5D-5L (0.12 index score and 20.5 VAS points, both p < 0.001), 3 of 4 WPAI domains (−31%, −32%, −32%, all p < 0.001), and 3 of 4 TSQM domains (18%, 23%, 29%, all p < 0.001) occurred from BL to week 26. Significant decreases in UC-related medical costs (−£1857, p < 0.001), all-cause direct costs (−£1613, p < 0.001), and UC-related direct + indirect costs (−£6001, p < 0.001) occurred 6 mo after starting ADA compared to 6 mo before starting ADA. Conclusion Real world rates of response, remission and improvements in HRQoL with ADA for UK patients with moderate to severe UC were clinically meaningful. ADA improved work productivity, increased patient satisfaction with therapy and reduced health care associated costs for these patients in the UK. Disclosure of Interest P. Irving Grant/research support from: AbbVie; Falk; Ferring; Genentech/Roche; Hospira; Merck; Pharmacosmos; Shire; Takeda; Tillotts; Topivert; Vifor and Warner Chilcott, Conflict with: Advisor/invited lecturer for: AbbVie; Falk; Ferring; Genentech/Roche; Hospira; Merck; Pharmacosmos; Shire; Takeda; Tillotts; Topivert; Vifor and Warner Chilcott, F. Cummings Conflict with: Advisor/lectures for: Takeda, Abbvie, MSD, Biogen, Napp, Hospira, Janssen, S. Bloom Conflict with: Advisor/lectures for: Takeda, Tillotts, Abbvie, MSD, Pharmacosmos, Vifor, Johnson and Johnson, A. Lazar Shareholder of: AbbVie, Employee of: AbbVie, A. Robinson Shareholder of: AbbVie, Employee of: AbbVie, B. Pappalardo Shareholder of: AbbVie, Employee of: AbbVie, M. Bereswill Shareholder of: AbbVie, Employee of: AbbVie, M. Skup Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, T. Finney-Hayward Shareholder of: AbbVie, Employee of: AbbVie, S. Wang Shareholder of: AbbVie, Employee of: AbbVie, R. Thakkar Shareholder of: AbbVie, Employee of: AbbVie, S. Travis Grant/research support from: AbbVie; Asahi; Boehringer Ingelheim; BMS; Cosmo; Elan; Ferring; FPRT Bio; Genentech/Roche; Genzyme; Glenmark; GW Pharmaceuticals; Lilly; Merck; Novartis; Novo Nordisk; Ocera; Pfizer; Shire; Santarus; SigmoidPharma; Synthon; Takeda; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria, Conflict with: Advisor or paid instructor for: AbbVie; Asahi; Boehringer Ingelheim; BMS; Cosmo; Elan; Ferring; FPRT Bio; Genentech/Roche; Genzyme; Glenmark; GW Pharmaceuticals; Lilly; Merck; Novartis; Novo Nordisk; Ocera; Pfizer; Shire; Santarus; SigmoidPharma; Synthon; Takeda; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria. All advisory boards were suspended Q1 2012–14 while President of ECCO
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».