Joseph Cappelleri | Pfizer Inc (original) (raw)

Papers by Joseph Cappelleri

Journal of Pain Research, Apr 1, 2015

Background: Similarities and differences on the nine-item and seven-item versions of painDETECT, ... more Background: Similarities and differences on the nine-item and seven-item versions of painDETECT, a patient-reported screener to identify neuropathic pain (NeP), have not been psychometrically explored across NeP conditions. Methods: Scores on the nine-item painDETECT (seven pain symptom items, one pain course pattern item, one pain radiation item) range from-1 to 38; scores $19 indicate NeP is likely (.90% probability). The seven-item version (only pain symptoms) score range is 0 to 35. painDETECT was administered to subjects with confirmed diagnoses of human immunodeficiency virus-related peripheral NeP (HIVP) (n=103), spinal cord injury-related NeP (SCI) (n=103), small fiber neuropathy (n=100), painful diabetic peripheral neuropathy (n=112), posttrauma/ postsurgical NeP (n=100), and NeP in chronic low back pain (n=106) identified during office visits to US community-based physicians. Analysis of covariance compared mean scores (adjusted for age, sex, race, ethnicity, time since NeP diagnosis, and number of comorbidities) on the nine-item and seven-item versions of painDETECT. Cronbach's alpha assessed internal consistency reliability, and corrected item-to-total correlations assessed item-level discrimination. Results: The adjusted mean nine-item scores ranged from 21.0 (SCI) to 24.3 (small fiber neuropathy). Differences between conditions were either trivial or small-to-medium in magnitude. Cronbach's alpha gave overall internal consistency reliability of 0.76, with a range of 0.63 (SCI) to 0.82 (HIVP). Mean scores and Cronbach's alphas for the seven-item version were generally similar to the nine-item version. Corrected item-to-total correlations adequately discriminated all pain symptom items on both painDETECT versions for each condition (0.3-0.7), but the two nonsensory items on the nine-item version showed lackluster discrimination (,0.3). Conclusion: painDETECT scores were within the range indicating high probability of NeP. Differences between conditions were generally modest or not large. Both versions showed evidence of internal consistency reliability and item-level discrimination, suggesting that pain-DETECT is a useful screening measure for identifying NeP across NeP conditions.

Pain Practice, Feb 7, 2018

Objective: To evaluate the effectiveness of opioids and/or pregabalin on patient-reported outcome... more Objective: To evaluate the effectiveness of opioids and/or pregabalin on patient-reported outcomes among fibromyalgia (FM) patients based on levels of improvement. Methods: A total of 1,421 FM patients were identified, with 3,082 observational periods of opioids with or without pregabalin use between April 2008 and February 2015. Patients were categorized by opioids, and pregabalin with and without opioids; opioids were designated by morphine equivalent dose (MED) of ≤ 20 (low MED), > 20 to < 100 (moderate MED), ≥ 100 (high MED), and pregabalin doses of ≤ 150 mg, 151 to 300 mg, and 301 to 450 mg. Proportions of patients meeting clinically relevant thresholds of ≥ 30% and ≥ 50% improvement for pain interference (ability to enjoy life; activity; mood; relationships; sleep), pain severity, and fatigue were compared among treatments, and area under the curve (AUC) for improvement and worsening of effects was determined, enabling ranking of treatments. Further analysis compared pregabalin doses. Results: Pregabalin without opioids resulted in the highest proportions of patients with ≥ 30% improvement on all pain items and pain interference with "ability to enjoy life," "activity" "mood," and "sleep." For the ≥ 50% threshold, pregabalin alone was highest for all pain interference items and for "average pain" and "worst pain." Pregabalin was consistently lowest across thresholds for fatigue, but showed better results combined with moderate MED opioids. Pregabalin doses recommended for treatment of FM (151 to 450 mg) generally resulted in the highest proportion of patients achieving thresholds relative to opioids. The AUC results were consistent with thresholds; pregabalin without opioids resulted in the greatest benefits with regard to improvement, with the highest ranking for overall improvement and overall effects. Conclusion: Pregabalin without opioids provided the most favorable outcomes overall based on ≥ 30% and ≥ 50% improvement thresholds and AUC, with support for moderate MED opioids + pregabalin in patients suffering from fatigue. While most patients took less than recommended pregabalin doses, higher doses may lead to improved outcomes. &

BMC Health Services Research, Apr 15, 2015

Background: Anticipating and controlling drug-drug interactions (DDIs) in older patients with pai... more Background: Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization. Methods: Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/ 2012, and ≥12 months pre-and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims. Results: No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of morphine equivalents/ 30 days used (60.2 mg and 176.9 mg, respectively; p = 0.058). Conclusion: The significantly higher prevalence of potential DDIs and potential cost impact found in pDPN duloxetine users, relative to pregabalin users, underscore the importance of considering DDIs when selecting a treatment.

Journal of Pain Research, 2019

Objectives: Estimate the prevalence of neuropathic pain (NeP) among chronic pain patients attendi... more Objectives: Estimate the prevalence of neuropathic pain (NeP) among chronic pain patients attending Brazilian hospitals and pain clinics in São Paulo, Ceara, and Bahia and explore clinical characteristics by subtypes: painful diabetic peripheral neuropathy (pDPN), central neuropathic pain (CNP), chronic low back pain with a neuropathic component (CLBP-NeP), postherpetic neuralgia (PHN), post-traumatic neuropathic pain (PTN), and post-surgical neuropathic pain (PSN). Methods: Physicians screened patients reporting chronic pain for ≥3 months (n=2,118) for probable NeP, using the Douleur Neuropathique 4 questionnaire and physician assessment, and reported their NeP subtype(s), symptoms, and medications. Identified NeP patients completed a questionnaire including treatment experiences, quality of life EuroQol 5 Dimensions [EQ-5D]), pain severity and interference (Brief Pain Inventory [BPI]), and Work Productivity and Activity Impairment scales. Descriptive analyses were performed by NeP subtype. Results: The prevalence of probable NeP was 14.5% (n=307). NeP patients were mostly female (80.5%), middle-aged (mean [M]=52.5, SD=13.9), and Pardo (44.3%). Of those diagnosed with an NeP subtype (n=209), the largest proportions were CLBP-NeP (36.8%), followed by pDPN (18.7%), CNP (17.7%), PTN (17.2%), PSN (13.4%), and PHN (3.3%). Across subtypes, the most widely reported symptoms were numbness (range: 62.2%-89.7%) and hyperalgesia (range: 32.1%-76.9%) and the most commonly prescribed pain analgesics were NSAID (range: 18.2%-57.1%), opioids (range: 0.0%-39.3%), and antiepileptics (range: 18.2%-57.1%). PTN and PSN patients reported the least favorable EQ-5D index scores (M=0.42, SD=0.19) and BPI-Pain Severity scores (M=7.0, SD=1.9), respectively. Those diagnosed with CNP had the least favorable BPI-Pain Interference scores (M=6.0, SD=2.7). Patients with PHN reported the least impairment based on EQ-5D index scores (M=0.60, SD=0.04). Those with pDPN had the most favorable BPI scores (BPI-Pain Severity: M=4.6, SD=2.3; BPI-Pain Interference: M=4.7, SD=2.7). Conclusion: Evaluation of chronic pain patients in Brazil yielded a 14.5% probable NeP prevalence. NSAIDs and opioids were commonly used, and there was a high incidence of NePrelated symptoms with varying levels of dysfunction across subtypes.

Journal of Medical Economics, May 15, 2019

Aims: To evaluate the cost differences between a treatment strategy including tofacitinib (TOFA) ... more Aims: To evaluate the cost differences between a treatment strategy including tofacitinib (TOFA) vs treatment strategies including adalimumab (ADA), golimumab (GOL), infliximab (IFX), and vedolizumab (VEDO) among all patients with moderate-to-severe ulcerative colitis (UC) (further stratified by patients naïve/exposed to tumor necrosis factor inhibitors [TNFis]). Materials and methods: An Excel-based decision-analytic model was developed to evaluate costs from the perspective of a third-party US payer over 2 years. Efficacy and safety parameters were taken from prescribing information and published trials. All patients started induction therapy on the first treatment in the strategy and continued if efficacy criteria were met and no major adverse event occurred (in which cases they proceeded to the next treatment in the strategy). Results: The cost per member per month (PMPM) of the TOFA->IFX->VEDO->GOL strategy ($1.11) was lower than that of the ADA->IFX->VEDO->GOL strategy ($1.34; D ¼ Aˋ0.23)amongtheTNFinaı¨vepopulation(n¼204patientsoutofaplanofonemillionmembers).Similarly,theuseofTOFAbeforeADA(i.e.TOFA−>ADA−>IFX−>VEDO)wasalsoassociatedwithlowerPMPMcoststhantheuseofADAbeforeTOFA(i.e.ADA−>TOFA−>IFX−>VEDO):À0.23) among the TNFinaïve population (n ¼ 204 patients out of a plan of one million members). Similarly, the use of TOFA before ADA (i.e. TOFA->ADA->IFX-> VEDO) was also associated with lower PMPM costs than the use of ADA before TOFA (i.e. ADA->TOFA->IFX->VEDO): Aˋ0.23)amongtheTNFinaı¨vepopulation(n¼204patientsoutofaplanofonemillionmembers).Similarly,theuseofTOFAbeforeADA(i.e.TOFA−>ADA−>IFX−>VEDO)wasalsoassociatedwithlowerPMPMcoststhantheuseofADAbeforeTOFA(i.e.ADA−>TOFA−>IFX−>VEDO):1.15 vs 1.25(D¼1.25 (D ¼ 1.25(D¼À0.10). Similar, and often larger, differences were observed in both the overall moderate-to-severe population and the TNFiexposed population. Sensitivity analyses resulted in the same conclusions. Limitations: Our model relied on efficacy data from prescribing information and published trials, which were not head-to-head and slightly differed with respect to methods. Additionally, our model used representative minor and major ADRs (and the associated costs) to represent toxicity management, which was a simplifying assumption. Conclusions: This analysis, the first of its kind to evaluate TOFA visa -vis other advanced therapies in the US, suggests the early use of TOFA among both TNFi-naïve and TNFi-failure patients results in lower PMPM costs compared with other treatment alternatives.

RMD Open, 2019

To cite: Strand V, de Vlam K, covarrubias-cobos Ja, et al. tofacitinib or adalimumab versus place... more To cite: Strand V, de Vlam K, covarrubias-cobos Ja, et al. tofacitinib or adalimumab versus placebo: patientreported outcomes from OPal Broaden-a phase iii study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open 2019;5:e000806.

Pediatric Rheumatology

Background This study aimed to elicit and quantify preferences for treatments for juvenile idiopa... more Background This study aimed to elicit and quantify preferences for treatments for juvenile idiopathic arthritis (JIA). Methods We conducted a discrete-choice experiment among adolescents with JIA in the United States (US) (n = 197) and United Kingdom (UK) (n = 100) and caregivers of children with JIA in the US (n = 207) and UK (n = 200). In a series of questions, respondents chose between experimentally designed profiles for hypothetical JIA treatments that varied in efficacy (symptom control; time until next flare-up), side effects (stomachache, nausea, and vomiting; headaches), mode and frequency of administration, and the need for combination therapy. Using a random-parameters logit model, we estimated preference weights for these attributes, from which we derived their conditional relative importance. Results On average, respondents preferred greater symptom control; greater time until the next flare-up; less stomachache, nausea, and vomiting; and fewer headaches. However, adole...

Journal of Patient-Reported Outcomes, Sep 23, 2022

Background: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demo... more Background: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demonstrated good internal consistency and responsiveness to changes in clinical status among patients with ankylosing spondylitis (AS). We aimed to further evaluate the psychometric properties of the FACIT-F scale in adult patients with AS. Methods: Measurement properties of the FACIT-F scale were evaluated using data from tofacitinib phase 2/3 (NCT01786668/NCT03502616) studies in adult patients with active AS. Results: Second-order confirmatory factor modeling supported the measurement structure of the FACIT-F scale (Bentler's comparative fit index ≥ 0.91), and FACIT-F demonstrated excellent internal consistency (Cronbach's coefficient α ≥ 0.88) and test-retest reliability (Intraclass Correlation Coefficient ≥ 0.75). Correlation coefficients between FACIT-F and other patient-reported outcomes generally exceeded 0.40, supporting convergent validity. Meaningful within-patient change was estimated as 3.1-6.3 for FACIT-F total score, and 1.4-2.8 and 1.7-3.6 for FACIT-F Experience and Impact domain scores, respectively. Large (effect size ≥ 1.17 standard deviation units), statistically significant differences in FACIT-F domain/total scores between 'no disease activity' (Patient Global Assessment of Disease Activity [PtGA] = 0) and 'very active disease' (PtGA = 10) patient groups supported known-groups validity. Ability to detect change was evidenced by an approximately linear relationship between changes in FACIT-F and PtGA scores. Conclusions: FACIT-F is a reliable and valid measure for evaluating fatigue in adult patients with active AS. Trial registration: ClinicalTrials.gov; NCT01786668 (registered 6 February 2013, https:// clini caltr ials. gov/ ct2/ show/ NCT01 786668) and NCT03502616 (registered 11 April 2018, https:// clini caltr ials. gov/ ct2/ show/ NCT03 502616).

Annals of the Rheumatic Diseases, Jun 1, 2020

Background: Treatment effect on pain is a priority for patients (pts) with psoriatic arthritis (P... more Background: Treatment effect on pain is a priority for patients (pts) with psoriatic arthritis (PsA) and physicians. As pain is multidimensional, there is growing interest to understand the mechanisms of pain relief during treatment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. Previous analyses showed that the effect of tofacitinib on pain in pts with PsA was partially mediated through improvement of inflammation as assessed by C-reactive protein (CRP) and Swollen Joint Count (SJC). Additional potential inflammation-associated mediators that might contribute to tofacitinib's effect on pain include enthesitis and skin disease. Objectives: To describe the interrelationship between pain, tofacitinib treatment and potential inflammatory-associated outcomes, using mediation modelling. Methods: Data from two Phase 3 studies (OPAL Broaden [NCT01877668]; OPAL Beyond [NCT01882439]) of pts with active PsA treated with tofacitinib 5 mg twice daily (BID) or placebo were used; pts were tumour necrosis factor inhibitor (TNFi)-naïve or had previous inadequate response to ≥1 TNFi. All pts were treated continuously with a single conventional synthetic DMARD. Analyses were completed using pooled and individual study data at Months 1 and 3 (using mean scores across visits). Mediation modelling seeks to explain mechanisms underlying observed relationships between independent and dependent variables via other variables (mediators). This initial model included: treatment as the independent (explanatory) binary variable (tofacitinib 5 mg BID vs placebo); pain, measured by Patient's Assessment of Arthritis Pain (VAS, 0-100 mm), as the dependent (outcome) variable; mediators were: pt-reported Itch Severity Index (ISI); CRP; SJC; Psoriasis Area and Severity Index (PASI); and enthesitis, measured by Leeds Enthesitis Index (LEI) or Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC). The final model was revised based on results of the initial model. Results: The initial model (N=329; pooled data) showed that tofacitinib treatment affects pain mainly indirectly via ISI, CRP, SJC, PASI and enthesitis (LEI), with 16.0% (p=0.53) attributable to the direct effect. The indirect effect via SJC (<1%) was not significant (p=0.99); the indirect effect via PASI was contradictory (-14.4%, p=0.10). The final model (Figure 1) excluded SJC and PASI. Analysis of the final model (N=468; pooled data) revealed that 29.5% (p=0.0579) of tofacitinib treatment effect on pain was attributable to the direct effect, and 70.5% (p<0.0001) was attributable to the indirect effect. ISI, LEI and CRP mediated 37.4% (p=0.0002), 17.8% (p=0.0157) and 15.3% (p=0.0107) of the tofacitinib treatment effect on pain, respectively. Results for individual studies were consistent with pooled data, as were those when enthesitis was represented by SPARCC in the model. Conclusion: The majority of tofacitinib treatment effect on pain in pts with PsA is collectively mediated by itch, enthesitis and CRP, with itch being the main mediator of treatment effect (~37%), using mediation modelling analyses.

Journal of Crohn's and Colitis, Nov 8, 2018

Rheumatology and therapy, Jun 23, 2023

Introduction: Tofacitinib is an oral Janus kinase inhibitor for treatment of ankylosing spondylit... more Introduction: Tofacitinib is an oral Janus kinase inhibitor for treatment of ankylosing spondylitis (AS). Using mediation modelling, we describe interrelationships between fatigue, pain, morning stiffness, C-reactive protein (CRP) and tofacitinib treatment in patients with AS. Methods: Data from phase 2 (NCT01786668)/ phase 3 (NCT03502616) studies of patients

Dermatology and therapy, Mar 13, 2021

Introduction: Atopic dermatitis (AD) severity was measured in two phase 3 US studies of crisaboro... more Introduction: Atopic dermatitis (AD) severity was measured in two phase 3 US studies of crisaborole ointment, 2%, in patients aged C 2 years using the Investigator's Static Global Assessment (ISGA), an FDA-recommended scale. Eczema Area and Severity Index (EASI) is a validated scale used globally to assess AD severity in clinical trials. The objective of this study is to aid interpretability of ISGA by translating ISGA scores to EASI scores. Methods: ISGA was mapped to EASI using published EASI severity strata by Chopra et al. and Leshem et al. and pooled data from phase 3 trials CrisADe CORE 1 and CORE 2, which evaluated crisaborole in patients aged C 2 years with mild-to-moderate AD (crisaborole, n = 1016; vehicle, n = 506). Least squares mean (LSM) percentage change from baseline (%CFB) in EASI and proportion of patients with 50%, 75%, and 90% improvement (EASI-50, EASI-75, and EASI-90, respectively) on day 29 were computed for mapped EASI. The relationship between changes in ISGA and changes in EASI was assessed using data from three abrocitinib trials. Results: ISGA was mapped to EASI using 70,000 random simulations. LSM (standard error) for %CFB in mapped EASI at day 29 (crisaborole versus vehicle) was-26.3% (17) versus 45.2% (35) (P = 0.0671) using Chopra strata and-43.1% (4.6) versus-5.2% (8.4) (P \ 0.0001) using Leshem strata. EASI-50, EASI-75, and EASI-90 rates were 72.1% versus 57.6%, 63.0% versus 47.8%, and 55.0% versus 40.1%, respectively, using Chopra strata (P \ 0.0001 for each difference). These rates were 68.8% versus 54.0%, 54.8% versus 40.5%, and 38.9% versus 27.2%, respectively (P \ 0.0001 for each difference) using Leshem strata. Mean two-point improvement in ISGA was comparable to EASI-90. Conclusion: Mapped EASI results were consistent with ISGA results in crisaborole phase 3 trials. Simulation methodologies yielded consistent results and may aid in interpretability of ISGA across clinical studies.

were re-randomised to IXEQ2W or IXEQ4W. The primary objective was ACR20 at Wk 24, and an extensio... more were re-randomised to IXEQ2W or IXEQ4W. The primary objective was ACR20 at Wk 24, and an extension from Wks 24 to 156 is ongoing. In this analysis, efficacy was assessed at Wk 52 for the intent-to-treat (ITT) population of pts randomised to IXE at Wk 0 by Nail Psoriasis Severity Index (NAPSI) scores in pts with baseline fingernail psoriasis (IXEQ4W, n=89; IXEQ2W, n=74), PASI 75/90/100 response rates in pts with baseline BSA !3 (IXEQ4W, n=68; IXEQ2W, n=68), and the rate of Static Physician Global Assessment (sPGA) of psoriasis scores of 0 or 1 (0=cleared, 1=minimal) in pts with baseline sPGA !3 (IXEQ4W, n=60, IXEQ2W, n=62). For categorical variables, nonresponder imputation was used for missing data. Percent change from baseline was calculated using modified baseline observation carried forward. Results: At Wk 52, NAPSI total score (observed cases; mean (SD)) was 5.0 (12.7), 4.4 (7.6), IXEQ4W, IXEQ2W, respectively, with a mean percent change from baseline of À15.2 (19.7),-14.4 (19.0), IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving a NAPSI score of 0 (0=cleared) was 46.1% (n=41), 32.4% (n=24), IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving PASI responses was 60.3% (n=41), 54.4% (n=37) for PASI 75; 50.0% (n=34), 39.7% (n=27) for PASI 90; and 39.7% (n=27), 35.3% (n=24) for PASI 100, IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving sPGA 0 or 1 was 61.7% (n=37), 66.1% (n=41), IXEQ4W, IXEQ2W, respectively. Safety was consistent with the larger study population. Conclusions: In patients with active PsA, an inadequate response to TNF-inhibitors, and baseline fingernail or skin lesions, treatment with ixekizumab resulted in persistent 1 reduction and clearance of nail and skin lesions after 1 year.

Journal of Clinical Medicine, Jan 11, 2023

This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY

BMC Gastroenterology, Jan 19, 2023

Background To describe variations in treatment patterns, clinical outcomes, patient-reported outc... more Background To describe variations in treatment patterns, clinical outcomes, patient-reported outcomes (PRO), and physician and patient satisfaction in patients with moderate-to-severe ulcerative colitis (UC) treated with tofacitinib in a real-world setting. Methods Data were drawn from the Adelphi UC Disease Specific Programme ™ , a point-in-time survey of physicians and their consulting patients in the US and Europe. For inclusion in this analysis, gastroenterologists completed medical record forms for the next seven consecutive consulting patients with confirmed UC, plus a further two patient record forms for patients treated with tofacitinib. Those same patients then completed a patient-reported questionnaire. Results Gastroenterologists (n = 340) provided data for 2049 patients with UC, including 642 patients receiving tofacitinib. Physicians' most frequent reason for choosing tofacitinib was overall efficacy (71.3% of patients). The proportion of patients in remission increased with length of treatment, from 13.7% at [0, 4) weeks to 68.3% at [52+] weeks. Both physicians and patients reported that the Mayo components of stool frequency and blood in stool were reduced with time on treatment. Improvement in symptoms (bloody diarrhea, abdominal pain/cramps, urgency, rectal bleeding, fatigue/tiredness) was reported in the first weeks of treatment, and increased with time. At week [52+], mean score reductions from treatment initiation to current in overall symptom severity, pain, and fatigue were 2.2 (to a current mean score of 1.1), 2.2 (to 0.9), and 2.1 (to 1.0), respectively. Comparing patients at weeks [0, 4) and [52+] (all PROs, p < 0.0001), the increase in EQ-5D-5L index total score was 0.29 points and in SIBDQ total score was 20.5 points; percent reductions in WPAI absenteeism was 34.4%, presenteeism 26.8%, overall work impairment 40.9% and activity

BMJ Open Gastroenterology, Sep 1, 2020

Objective Ulcerative colitis (UC) is a lifelong, relapsing-remitting disease. Patients non-respon... more Objective Ulcerative colitis (UC) is a lifelong, relapsing-remitting disease. Patients non-responsive to pharmacological treatment may require a colectomy. We estimated pre-colectomy and post-colectomy healthcare resource utilisation (HCRU) and costs in England. Design/Method A retrospective, longitudinal cohort study indexing adult patients with UC undergoing colectomy (2009-2015), using linked Clinical Practice Research Datalink/Hospital Episode Statistics data, was conducted. HCRU, healthcare costs and pharmacological treatments were evaluated during 12 months prior to and including colectomy (baseline) and 24 months post-colectomy (followup; F-U), comparing baseline/F-U, emergency/elective colectomy and subtotal/full colectomy using descriptive statistics and paired/unpaired tests. Results 249 patients from 26 165 identified were analysed including 145 (58%) elective and 184 (74%) full colectomies. Number/cost of general practitioner consultations increased post-colectomy (p<0.001), and then decreased at 13-24 months (p<0.05). From baseline to F-U, the number of outpatient visits, number/cost of hospitalisations and total direct healthcare costs decreased (all p<0.01). Postoperative HCRU was similar between elective and emergency colectomies, except for the costs of colectomy-related hospitalisations and medication, which were lower in the elective group (p<0.05). Postoperative costs were higher for subtotal versus full colectomies (p<0.001). At 1-12 month F-U, 30%, 19% and 5% of patients received aminosalicylates, steroids and immunosuppressants, respectively. Conclusion HCRU/costs increased for primary care in the first year post-colectomy but decreased for secondary care, and varied according to the colectomy type. Ongoing and potentially unnecessary pharmacological therapy was seen in up to 30% of patients. These findings can inform patients and decision-makers of potential benefits and burdens of colectomy in UC.

RMD Open, Jun 1, 2022

Van den Bosch F, et al. Effect of tofacitinib on pain, fatigue, health-related quality of life an... more Van den Bosch F, et al. Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebocontrolled trial.

Journal of Crohn's and Colitis

Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulce... more Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). This novel analysis evaluated tofacitinib outcomes using items from the Inflammatory Bowel Disease Questionnaire-32 (IBDQ) and Short Form-36 Health Survey (SF-36) as proxies for key UC patient-reported outcomes (PROs) of fatigue, urgency, abdominal pain and sexual dysfunction over 52 weeks of maintenance treatment. Methods Data from 593 patients with UC in OCTAVE Sustain (NCT01458574) were included.1 PROs were assessed via self-reported proxy items for each UC symptom/dysfunction of interest in the IBDQ and SF-36. A longitudinal mixed-effects model compared tofacitinib 5 and 10 mg twice daily (BID) vs placebo up to 52 weeks for change from baseline (CFB) in each predefined IBDQ and SF-36 item. Least squares (LS) mean differences and standardised effect sizes (ES; LS mean difference divided by the standard deviation [SD] of baseline item scores) were calculated for to...

Annals of the Rheumatic Diseases, 2020

Background:With multiple disease domains affected in PsA, clinical and patient-reported outcome (... more Background:With multiple disease domains affected in PsA, clinical and patient-reported outcome (PRO) measures are important to assess disease improvement following treatment. Rapid, meaningful improvements in disease activity are a priority for physicians and patients (pts). Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. Higher proportions of pts achieved responses in PROs and clinical measures when treated with tofacitinib for 3 months vs placebo (PBO).1-5Proportions of responders were also similar between tofacitinib and adalimumab (ADA) after 3, 6 and 12 months.2,3,5Objectives:To determine the time to initial response using responder definitions for selected PROs and clinical endpoints in pts with active PsA treated with tofacitinib, ADA or PBO switching to tofacitinib.Methods:In this post hoc analysis, data were collected from two Phase 3 studies (OPAL Broaden [12 months;NCT01877668]; OPAL Beyond [6 months;NCT01882439]).3,4Pts receiving tofacitinib 5 or...

Annals of the Rheumatic Diseases, 2020

PsA is a chronic, systemic inflammatory disease with signs and symptoms across multiple domains, ... more PsA is a chronic, systemic inflammatory disease with signs and symptoms across multiple domains, including cutaneous manifestations, which can impact health-related quality of life (HQoL). Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. In two Phase 3 randomised studies, patients (pts) with active PsA treated with tofacitinib experienced greater improvements in various dermatologic endpoints, compared with placebo. As pruritus is a bothersome symptom of skin disease in pts with PsA, we sought to determine how tofacitinib affects HQoL via clinical improvements in skin symptoms including itch.To determine the relationships between tofacitinib treatment, dermatologic symptoms and pt-reported HQoL related to skin disease in PsA.Analyses used data (mean scores from Months 1 and 3) from two Phase 3 studies (OPAL Broaden [NCT01877668]; OPAL Beyond [NCT01882439]) of pts with active PsA treated with tofacitinib 5 mg twice daily or placebo; pts were tumour necrosis fac...

Journal of Pain Research, Apr 1, 2015

Pain Practice, Feb 7, 2018

BMC Health Services Research, Apr 15, 2015

Journal of Pain Research, 2019

Journal of Medical Economics, May 15, 2019

RMD Open, 2019

Pediatric Rheumatology

Journal of Patient-Reported Outcomes, Sep 23, 2022

Annals of the Rheumatic Diseases, Jun 1, 2020

Journal of Crohn's and Colitis, Nov 8, 2018

Rheumatology and therapy, Jun 23, 2023

Dermatology and therapy, Mar 13, 2021

Journal of Clinical Medicine, Jan 11, 2023

BMC Gastroenterology, Jan 19, 2023

BMJ Open Gastroenterology, Sep 1, 2020

RMD Open, Jun 1, 2022

Journal of Crohn's and Colitis

Annals of the Rheumatic Diseases, 2020