David Gruben
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View article: Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials
Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials Open
Objectives Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA). Design Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standar…
View article: Tofacitinib for the Treatment of Juvenile Idiopathic Arthritis: Patient‐Reported Outcomes in a Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Withdrawal Trial
Tofacitinib for the Treatment of Juvenile Idiopathic Arthritis: Patient‐Reported Outcomes in a Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Withdrawal Trial Open
Objective Juvenile idiopathic arthritis (JIA) is associated with impaired overall health‐related quality of life (HRQoL). We evaluated the impact of tofacitinib on patient‐reported outcomes (PROs) in patients with JIA. Methods This was a p…
View article: Characterization of Second‐Line Therapy After First <scp>JAK</scp> Inhibitor Use: Results From the <scp>CorEvitas</scp> Rheumatoid Arthritis Registry
Characterization of Second‐Line Therapy After First <span>JAK</span> Inhibitor Use: Results From the <span>CorEvitas</span> Rheumatoid Arthritis Registry Open
Objective We performed a real‐world characterization of patients with rheumatoid arthritis (RA) who initiate a JAK inhibitor (JAKi) and switch to a subsequent therapy and examination of factors associated with the use of another JAKi/thera…
View article: Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials
Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials Open
ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.
View article: Real-world familiarity with US biosimilar regulatory guidelines and interchangeability state laws among pharmacists and physicians treating immunological disorders
Real-world familiarity with US biosimilar regulatory guidelines and interchangeability state laws among pharmacists and physicians treating immunological disorders Open
Pharmacists reported higher rates of familiarity and training with biosimilars and recommendation of biosimilars to patients than physicians. A diverse sample of physicians and pharmacists expressed perceived barriers and strategies to imp…
View article: Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies
Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies Open
Objective To capture variations in tofacitinib treatment response in psoriatic arthritis (PsA) by identifying patient groups with distinct disease activity trajectories. Methods Data were pooled post hoc from two phase 3 studies (OPAL Broa…
View article: Efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis in induction and maintenance: systematic literature review and Bayesian network meta-analysis
Efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis in induction and maintenance: systematic literature review and Bayesian network meta-analysis Open
Aim: Several therapies have recently been licensed for the treatment of patients with moderately to severely active ulcerative colitis (UC). To provide comparative evidence of newly available treatments, Bayesian network meta-analyses were…
View article: Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod and ozanimod for moderately to severely active ulcerative colitis
Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod and ozanimod for moderately to severely active ulcerative colitis Open
Aim: Etrasimod and ozanimod are selective sphingosine 1-phosphate receptor modulators targeting the S1P 1,4,5 , and S1P 1,5 receptors, respectively, for the treatment of patients with moderately to severely active ulcerative colitis (UC). …
View article: Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study
Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study Open
In concordance with studies of background risk, AEs were more common in patients with CV risk enrichment, particularly those aged ≥ 65 years. Tofacitinib effectiveness/persistence were generally similar regardless of CV risk enrichment. Th…
View article: Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12
Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12 Open
Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). Here, we evaluate the impact of etrasimod 2 mg QD on he…
View article: Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status
Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status Open
ClinicalTrials.gov: NCT01877668/NCT01882439/NCT03486457/NCT01976364/NCT01786668/NCT03502616.
View article: P849 Bayesian network meta-analysis of the efficacy of advanced therapies for patients with moderately to severely active ulcerative colitis naïve to advanced therapy
P849 Bayesian network meta-analysis of the efficacy of advanced therapies for patients with moderately to severely active ulcerative colitis naïve to advanced therapy Open
Background Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). In the absence of head-to-head randomised controlled t…
View article: Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials
Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials Open
NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB).
View article: Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension
Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension Open
Background Evaluate the impact of sex on tofacitinib efficacy, safety and persistence (time to discontinuation) in patients with psoriatic arthritis (PsA). Methods Data were pooled from two phase 3 randomised controlled trials. Patients we…
View article: High Usability and Applicability Ratings for the New SmartClic®/ClicWise® Injection Device: Evidence from a Health Care Professional Opinion Study
High Usability and Applicability Ratings for the New SmartClic®/ClicWise® Injection Device: Evidence from a Health Care Professional Opinion Study Open
The above plain language summary represents the opinions of the authors. For a full list of declarations, including funding and author disclosure statements, please see the full text online (see “read the peer-reviewed publication” opposit…
View article: Comorbidities, Healthcare Utilization, and Costs Associated With Alopecia Totalis and Alopecia Universalis in the United States
Comorbidities, Healthcare Utilization, and Costs Associated With Alopecia Totalis and Alopecia Universalis in the United States Open
Background: Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. Extensive forms of AA include alopecia totalis (AT; complete scalp hair loss) or alopecia universalis (AU; complete scalp, face, and body hai…
View article: Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study
Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study Open
Objective The Canadian Tofacitinib for Rheumatoid Arthritis Observational (CANTORAL) is the first Canadian prospective, observational study assessing tofacitinib. The objective was to assess effectiveness and safety for moderate to severe …
View article: Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination
Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination Open
The findings from this analysis of real-world data indicate that patients who initiate tofacitinib in combination with oral MTX may discontinue MTX and still experience outcomes similar to those in patients who persist with MTX, with lesse…
View article: Economic Burden and Healthcare Resource Use of Alopecia Areata in an Insured Population in the USA
Economic Burden and Healthcare Resource Use of Alopecia Areata in an Insured Population in the USA Open
Alopecia areata is associated with significant incremental healthcare resource utilization and costs relative to matched controls due to increased spending in areas such as surgical procedures and psychological and pharmacological interven…
View article: Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey
Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey Open
Clinical and humanistic burden was observed in European respondents with AD compared with matched non-AD controls across severity levels, with burden evident even in milder disease, highlighting the importance of improving disease manageme…
View article: Retrospective Database Analysis: Dose Escalation and Adherence in Patients Initiating Biologics for Ulcerative Colitis
Retrospective Database Analysis: Dose Escalation and Adherence in Patients Initiating Biologics for Ulcerative Colitis Open
Background: Biologic therapies are often used in patients with ulcerative colitis (UC) who are nonresponsive to conventional treatments. However, nonresponse or loss of response to biologics often occurs, leading to dose escalation, combin…
View article: Identification of Distinct Disease Activity Trajectories in Methotrexate‐Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty‐Four Months
Identification of Distinct Disease Activity Trajectories in Methotrexate‐Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty‐Four Months Open
Objective Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). To better understand tofacitinib treatment responses, we used group‐based trajectory modeling to investigate distinct disease activity trajector…
View article: Demographic diversity of participants in Pfizer sponsored clinical trials in the United States
Demographic diversity of participants in Pfizer sponsored clinical trials in the United States Open
The approval of new medicinal agents requires robust efficacy and safety clinical trial data demonstrated to be applicable to population subgroups. Limited data have previously been reported by drug sponsors on the topic of clinical trial …