Roopal Thakkar
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View article: A vision for integrated publicly available information on regulated medical products
A vision for integrated publicly available information on regulated medical products Open
This perspective provides a vision for seamless access to publicly available information on regulated medical products supporting innovation and informed decision making. Current information shared by regulators postapproval is generally a…
View article: COVID‐19: A Catalyst to Accelerate Global Regulatory Transformation
COVID‐19: A Catalyst to Accelerate Global Regulatory Transformation Open
All authors are employed by multinational biopharmaceutical companies, as indicated in their affiliations: J.S. (Pfizer), P.H. (Pfizer), L.A. (Merck), D.A. (Astra Zeneca), S.B. (Bristol-Myers Squibb), P.B. (Bayer), H.F. (Glaxo Smith Kline)…
View article: Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease
Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease Open
In a phase 2 trial of patients with CD, upadacitinib induced endoscopic remission in a significant proportion of patients compared with placebo. Upadacitinib's benefit/risk profile supports further development for treatment of CD. (Clinica…
View article: A68 COST EFFECTIVENESS OF TIGHT CONTROL FOR CROHN’S DISEASE WITH ADALIMUMAB-BASED TREATMENT: ECONOMIC EVALUATION OF CALM TRIAL FROM CANADIAN PERSPECTIVE
A68 COST EFFECTIVENESS OF TIGHT CONTROL FOR CROHN’S DISEASE WITH ADALIMUMAB-BASED TREATMENT: ECONOMIC EVALUATION OF CALM TRIAL FROM CANADIAN PERSPECTIVE Open
BACKGROUND: Tight control (TC) for Crohn’s disease (CD), using symptoms plus biomarkers (faecal calprotectin, C-reactive protein) to direct adalimumab (ADA) treatment, was associated with improved outcomes and considered cost effective (fr…
View article: Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry
Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry Open
Background PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice. Methods Adult patients with moderatel…
View article: Open : Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-up in the PYRAMID Registry
Open : Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-up in the PYRAMID Registry Open
PYRAMID is the longest prospective adalimumab study in routine clinical practice, with up to 6 years of follow-up. No new safety signals were reported. The pre-specified registry objective of ruling out a doubling of lymphoma risk with ada…
View article: Performance of Crohn’s disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data
Performance of Crohn’s disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data Open
This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in …
View article: DOP071 Tight control with adalimumab-based treatment is associated with improved quality of life outcomes in patients with moderate to severely active Crohn’s disease: data from CALM
DOP071 Tight control with adalimumab-based treatment is associated with improved quality of life outcomes in patients with moderate to severely active Crohn’s disease: data from CALM Open
The Phase 3 CALM study demonstrated that tight control (TC) of inflammation based on biomarkers led to superior clinical outcomes including endoscopic and deep remission in patients with moderate to severe Crohn’s disease (CD) compared wit…
View article: DOP065 Long-term cost-effectiveness of tight control for Crohn’s disease with adalimumab-based treatment: economic evaluation beyond 48 weeks of CALM trial
DOP065 Long-term cost-effectiveness of tight control for Crohn’s disease with adalimumab-based treatment: economic evaluation beyond 48 weeks of CALM trial Open
Tight control (TC) for Crohn’s disease (CD), using biomarkers (faecal calprotectin and C-reactive protein) to direct adalimumab (ADA) treatment, was associated with improved outcomes and considered cost-effective compared with clinical man…
View article: Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA
Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA Open
ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC.
View article: Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis
Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis Open
The efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis was maintained for up to 4 years of treatment. No new safety signals were observed.
View article: Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohnʼs Disease
Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohnʼs Disease Open
ADA treatment resulted in growth rate normalization as early as week 26 in children with moderately to severely active Crohn's disease and growth impairment.
View article: Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohnʼs Disease
Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohnʼs Disease Open
Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.
View article: P329 Effect of adalimumab dose escalation on clinical, health-related quality of life, treatment satisfaction and work productivity outcomes among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA
P329 Effect of adalimumab dose escalation on clinical, health-related quality of life, treatment satisfaction and work productivity outcomes among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA Open
Background: Although adalimumab (ADA) has been shown to induce and maintain clinical remission in moderate to severe ulcerative colitis (UC), some patients (pts) may lose initial response and could benefit from dose escalation [1]. We asse…
View article: DOP018 Effect of adalimumab on extraintestinal manifestations among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA
DOP018 Effect of adalimumab on extraintestinal manifestations among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA Open
Background: Extraintestinal manifestations (EIMs) are common in patients with ulcerative colitis (UC) and can have a significant impact on patient morbidity and quality of life [1]. We assessed the effect of adalimumab (ADA) therapy on the…
View article: Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial
Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial Open
This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcome…
View article: Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn’s Disease Who Lost Response to Maintenance Therapy
Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn’s Disease Who Lost Response to Maintenance Therapy Open
Background: Dose escalation is often recommended for loss of response in anti-TNFα-treated patients with Crohn’s disease (CD). This 52-week phase 3, multicenter study investigated the efficacy and safety of escalation to adalimumab 80 mg e…
View article: Effects of concomitant immunomodulators on the pharmacokinetics, efficacy and safety of adalimumab in patients with Crohn's disease or ulcerative colitis who had failed conventional therapy
Effects of concomitant immunomodulators on the pharmacokinetics, efficacy and safety of adalimumab in patients with Crohn's disease or ulcerative colitis who had failed conventional therapy Open
Summary Background Adalimumab is approved for use in patients with moderate to severe Crohn's disease ( CD ) or ulcerative colitis ( UC ) who have not achieved disease control with conventional therapies including corticosteroids and/or im…
View article: Characterisation of Mucosal Healing with Adalimumab Treatment in Patients with Moderately to Severely Active Crohn’s Disease: Results from the EXTEND Trial
Characterisation of Mucosal Healing with Adalimumab Treatment in Patients with Moderately to Severely Active Crohn’s Disease: Results from the EXTEND Trial Open
Mucosal healing [MH] is an important goal for patients with Crohn's disease [CD], yet is incompletely characterised. We investigated whether MH differed by segments across the colon and ileum in patients who received adalimumab maintenance…
View article: Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohnʼs Disease
Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohnʼs Disease Open
Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.
View article: P398. The costs of care for patients with ulcerative colitis: effect of adalimumab on health care resources utilisation in clinical practice from INSPIRADA
P398. The costs of care for patients with ulcerative colitis: effect of adalimumab on health care resources utilisation in clinical practice from INSPIRADA Open
The clinical outcome was related to clinical (PUCAI score), laboratory (CsA concentration), endoscopic (disease extension and severity), demographic (age, age of onset, and disease duration) data, and previous anti-TNFalpha exposure.Result…
View article: DOP083. Faecal calprotectin improves the predictive power of 3 practical indices for mucosal healing amongst patients with Crohn’s disease: results from PREDICT
DOP083. Faecal calprotectin improves the predictive power of 3 practical indices for mucosal healing amongst patients with Crohn’s disease: results from PREDICT Open
Background: Inflammatory bowel disease (IBD) is a chronic condition with high rate of morbidity and disability, associated with high social and medical costs.It is important, therefore, to select carefully
View article: Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease
Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease Open
Adalimumab serum concentrations in Chinese patients with CD were comparable to those observed previously in Western and Japanese patients. Clinically meaningful remission rates and improvement in inflammatory markers were achieved with bot…