Total Activity Impairment Research Articles

The effects of adalimumab treatment and psoriasis severity on self-reported work productivity and activity impairment for patients with moderate to severe psoriasis

Psoriasis significantly impairs work productivity and daily activities. We sought to examine the effects of adalimumab on psoriasis-related work productivity and activity impairment and associations between the impairment and psoriasis severity in patients with moderate to severe psoriasis. Data were from the first 16 weeks of the Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis TriAL (REVEAL). Outcomes as measured by the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-Psoriasis) included employment status, total work productivity impairment, and total activity impairment. Logistic regression and analyses of covariance were used to assess the effects of adalimumab and treatment response (≥ 75% improvement in Psoriasis Area and Severity Index responders) on WPAI-Psoriasis outcomes. Longitudinal generalized estimating equations and Pearson correlation coefficients were used to assess associations between WPAI outcomes and psoriasis severity. Greater improvements in total work productivity impairment and total activity impairment were observed with adalimumab treatment versus placebo (15.5 and 11.1 percentage points, respectively; P < .001). Unemployment rate, total work productivity impairment, and total activity impairment were significantly associated with greater baseline psoriasis severity. Changes in WPAI outcomes were significantly correlated with greater psoriasis severity. The Dermatology Life Quality Index had stronger associations with changes in WPAI outcomes compared with clinical severity measures (Psoriasis Area and Severity Index and Physician Global Assessment). REVEAL only included WPAI data for 16 weeks. Therefore, long-term impact of adalimumab treatment on productivity outcomes could not be assessed. In addition, information on occupational job title or industry was not collected and data were not adjusted for psoriatic arthritis. Adalimumab reduced psoriasis-related work productivity and activity impairment in patients with moderate to severe psoriasis.

Work Productivity Improvements in Adalimumab-treated Patients with Moderate to Severe Ileocolonic Crohnʼs Disease: The EXTEND Trial

Purpose: The ability of anti-tumor necrosis factor (anti-TNF) therapy to restore work capacity in Crohn's disease (CD) has not been fully defined. We assessed the impact of adalimumab on work productivity in EXTEND, a 52-week, placebo-controlled study of the effect of adalimumab on mucosal healing in patients with moderate to severe ileocolonic CD. Methods: All patients received open-label adalimumab 160-/80-mg induction therapy at Weeks 0/2 and were randomized to adalimumab 40 mg every other week (eow) or placebo at Week 4. From Week 8, patients with flares or nonresponse could receive open-label adalimumab. The Work Productivity and Activity Impairment Questionnaire (WPAI) is a validated, self-administered tool that assesses impact of disease on productivity. The WPAI measures CD-related impairment in work productivity and daily activity via 4 component scores: absenteeism (CD-related absence from work), presenteeism (CD-related impairment of productivity during work), total work productivity impairment (TWPI; absenteeism and presenteeism combined), and total activity impairment (TAI; CD-related daily activity impairment). Differences in productivity between the continuous adalimumab group and the inductiononly placebo group were analyzed for the double-blind period via last-observation-carried-forward (LOCF) imputation. Only evaluations after Week 4 of double-blind treatment were carried forward; data after first open-label dose were excluded. Results: Of 129 patients randomized in EXTEND, 63% were women, 92% were white, mean age was 37 years, mean Crohn's Disease Activity Index was 320, mean CD duration was 10 years, and 61% were anti-TNF experienced. Concomitant steroids were used by 26% and immunosuppressants, by 41%. At Week 4, following treatment with the loading dose, all components of WPAI improved significantly (absenteeism: -18; presenteeism: -25; TWPI: -28; TAI: -25). At Week 52, the continuous adalimumab group experienced significant improvements in missed work time, daily activity impairment, and overall work impairment vs. the induction-only placebo group (Table). Conclusion: Adalimumab maintenance therapy was associated with significant and sustained improvements in work productivity and daily activity compared with the induction-only placebo therapy in patients with moderate to severe ileocolonic CD. Disclosure: Dr Binion - Speaker's bureau: Abbott Laboratories, Centocor, Elan Pharmaceuticals, Procter & Gamble Pharmaceuticals, Prometheus, Salix, Shire, and UCB Grants: the National Institute of Health, Centocor, Elan Biogen and Procter & Gamble Pharmaceuticals. Dr Rutgeerts - Served as study investigator and consultant for Abbott Laboratories and has participated in continuing medical education events supported by unrestricted educational grants from Abbott (research support, consultant fees, speaker's fees) Dr Chen - Employee - Abbott Dr Chao - Employee, stocks - Abbott Dr Mulani - Employee, stocks - Abbott. This research was funded by Abbott Laboratories, Abbott Park, IL.Table: WPAI change from baseline to week 52: LOCF

P061 - Reduction in extraintestinal manifestations of Crohn's disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S35 P061 Reduction in extraintestinal manifestations of Crohn’s disease is associated with improvements in patient-reported and disease activity outcomes in patients treated with adalimumab W. Reinisch1 *, R. Lofberg2, E. Louis3, A.P. Yu4, J. McHale4, N. Beaulieu4, P. Mulani5, J. Chao5. 1Medical University of Vienna, Vienna, Austria, 2Karolinska Institutet, Stockholm, Sweden, 3University of Liege, Liege, Belgium, 4Analysis Group, Boston, MA, USA, 5Abbott, Abbott Park, IL, USA Introduction: Adalimumab is approved for treatment of adults with active Crohn’s disease (CD) and has been shown to induce and maintain remission in patients who have had an inadequate response to conventional therapy. CD is associated with extraintestinal manifestations (EIMs) in approximately 25% of patients.1 The objective of this analysis was to assess the impact of EIMs on patient-reported outcomes (PROs) and disease activity in patients with CD. Methods: The Crohn’s Patients Treated With Adalimumab: Results of a Safety and Efficacy Study (CARE) enrolled 945 patients with moderate to severe CD (Harvey Bradshaw Index [HBI] score 7). CARE was a multicenter, open-label, European, Phase IIIb trial evaluating the efficacy and safety of adalimumab in a large population of patients whose treatment approximated usual clinical practice. Outcomes included Short Inflammatory Bowel Disease Questionnaire (SIBDQ), 4 components of the Work Productivity and Activity Impairment (WPAI) questionnaire (total activity impairment [TAI], total work productivity impairment [TWPI], absenteeism, and presenteeism), and HBI. Presence of EIMs was assessed clinically as part of the baseline physical examination, and healing and development of new EIMs were evaluated at each scheduled visit at 2, 4, 8, 12, and 20 weeks after initiation of adalimumab therapy. A comparison of patients with and without EIMs at baseline was conducted to assess differences in demographics, PROs, and CD-related outcomes. Multivariate regression analyses were used to assess the impact of a reduction in EIMs on outcomes at Week 20, controlling for baseline characteristics. Results: At baseline, 52.6% (n = 497) of patients reported having 1 EIM, with an average of 1.4. EIMs reported in the patient population included erythema nodosum, pyoderma gangrenosum, eye involvement, arthritis, arthralgia, sacroiliitis, ankylosing spondylitis, hepatic disease, thrombosis, and nephrolithiasis. Patients with EIMs had more disease activity (ie, greater HBI), poorer SIBDQ, more impairment in daily activity as measured by TAI, and more CD-related symptoms at baseline than those without EIMs (p < 0.001). Patients who had longer duration of CD had, on average, more EIMs at baseline. Of the 497 patients with EIMs at baseline, 63.4% (n = 315) experienced a decrease in the number of EIMs at Week 20 of treatment with adalimumab. Regression analysis demonstrated that a decrease in the number of EIMs at Week 20 was a statistically significant predictor of improvements in patient-reported and disease activity outcomes, after controlling for baseline characteristics (table). Coefficients of reductions in number of EIMs in predicting HRQOL and disease activity scores at Week 20 in CARE: Results of linear regression analysis SIBDQ estimate 2.40**