subanalysis of the noninterventional study lotos: improved work ability status in psoriasis patients...

P7005Subanalysis of the noninterventional study LOTOS: Correlation betweenmeasures of disease activity and identification of treatment response predic-tors inpsoriasis patients treatedwith adalimumabduring routine clinical care

Michaela K€ohm, MD, CIRI/Division of Rheumatology J. W. Goethe-UniversityFrankfurt/Main, Frankfurt am Main, Germany; Bianca Wittig, MD, Abbott Germany,Wiesbaden, Germany; Diamant Thaci, MD, Department of Dermatology, J. W. Goethe-University, Frankfurt/Main, Germany; Frank Behrens, MD, CIRI/Division ofRheumatology J. W. Goethe-University Frankfurt/Main, Frankfurt am Main, Germany;Hans-Joachim L€udcke, MD, Dermatologic Practice, Potsdam, Germany; Sandra Philipp,MD, Charit�e Universit€atsmedizin Berlin, Department of Dermatology, Venerology andAllergy, Berlin, Germany; Simone Rubant, MD, Abbott Germany, Wiesbaden, Germany

Objectives: To evaluate the correlation between measures of disease activity andidentify predictors of treatment response in patients with moderate to severeplaque-type psoriasis treated with adalimumab in routine clinical care.

Methods: A multicenter, prospective observational study included patients withmoderate to severe psoriasis, treated with adalimumab. Disease activity assessmentsincluding Psoriasis Area and Severity Index (PASI) and physician’s global assessmentof disease activity (PGA) were calculated at baseline, month 3, 6, and 12. Predictorsfor therapeutic response were determined by step-wise regression analyses.

Results: Data from 488 patients were analyzed. In contrast to previous analyses,patientswith signs ofpsoriatic arthritiswere excluded.Meanagewas47.7years, 68.2%were males, 31.8% females; mean BMI (kg/m2) was 28.3; mean disease duration 21.2years. Previous systemic therapies were MTX 81.9%, fumaric acid esters 89.5%,cyclosporin 60.5%, leflunomide 3.0%, efalizumab 43.0%, etanercept 29.0%, andinfliximab 14.1%. Before therapy initiation, patients showed moderate to severedisease activityas indicatedbymeanPASI (20.9) andPGA(3.5).After a treatmentperiodof3months,meanPASI decreased to8.0, showing further reduction to4.2 atmonth12.PGA decreased to 1.9 at month 3 and 1.3 at month 12. About two-thirds of patients(67.1%) achieved a 75% reduction in PASI score (PASI 75 response) at month 12. PASIand PGA were highly correlated at baseline and at month 12 (rho ¼ 0.64 and 0.75,respectively). Baseline disease activity was a positive predictor for reduction of bothPASI and PGA. Patients with higher baseline values showed more improvement. Highvalues of bodymass index (BMI)were identified as a negative predictor for bothdiseaseactivitymeasures. Pustular psoriasiswas a negative predictor of improvement for PASI.

Conclusion: In patients with psoriasis, measures of disease activity showed markedimprovement during 12 months of adalimumab therapy. PASI and PGA were highlycorrelated at baseline and at 12 months. In this cohort of patients with psoriasis(excluding patients with signs of psoriatic arthritis), baseline disease activity was thestrongest predictor for therapeutic response. Step-wise regression analyses of PASIand PGA response showed good agreement; both were influenced by baselinedisease activity as a positive predictor and high baseline BMI as a negative predictorfor therapeutic response.

AB214

interventional study was sponsored by Abbott Germany.

P7130Subanalysis of the noninterventional study LOTOS: Improved work abilitystatus inpsoriasispatients treatedwithadalimumabduringroutineclinicalcare

Michaela K€ohm, MD, CIRI/Division of Rheumatology J. W. Goethe-University,Frankfurt/Main, Frankfurt am Main, Germany; Bianca Wittig, MD, Abbott Germany,Wiesbaden, Germany; Diamant Thaci, MD, Department of Dermatology, J. W.Goethe-University, Frankfurt/Main, Germany, Frankfurt/Main, Germany; FrankBehrens, MD, CIRI/Division of Rheumatology J. W. Goethe-University,Frankfurt/Main, Frankfurt am Main, Germany; Gerd Greger, MD, Abbott Germany,Wiesbaden, Germany; Johannes Norgauer, MD, Department of Dermatology,Friedrich Schiller University Jena, Jena, Germany; Rudolf Schopf, MD, Departmentof Dermatology/Venerology, J. Gutenberg-University, Mainz, Germany

Objective: To evaluate the effects of 12 months of adalimumab treatment on workability and psoriasis-related work absence days in patients with moderate to severepsoriasis.

Methods: A multicenter, prospective observational study included patients with mod-erate to severe psoriasis treated with adalimumab in routine clinical care. Work abilitywas measured using Work Ability Index (WAI) and psoriasis-related sick certificates foremployed patients during 6months beforebaseline and the 12-month treatment course.The WAI is a patient self-assessment questionnaire with items concerning work, workability, and health status. Psoriasis Area and Severity Index (PASI), body surface area(BSA), and physician’s global assessment (PGA) were used as efficacy measurements.

Results: Data from 173 employed patients were analyzed. In contrast to a previousreport,patientswithpsoriatic arthritiswere excluded.Themeanagewas43years, 77%of the patients were male, and mean disease duration was 20 years. Between baselineandmonth12,meanPASI values decreased from19.5 to3.1,meanPGA from3.4 to 1.1,and mean BSA from 35.1% to 7.8%, respectively. After 12 months of treatment, theproportionofpatientswithpoor ormoderateworkability status decreased from19.1%at baseline to 5.2%, whereas the proportion of patients with good or excellent workability status improved from 80.7% at baseline to 94.8% at month 12. Additionally, theproportion of patients with psoriasis-related sick certificates in the past 6 monthsdecreased from 14.2% to 2.1%, and the mean duration of psoriasis-related workabsence decreased from 3.6 days at baseline to 0.5 days after 12 months of treatment.

Conclusion: PASI, PGA, and BSA showed significant decreases over the 12-monthtreatment period, indicating good efficacy of adalimumab in psoriasis patientstreated in routine clinical care. Earlier analyses of a larger cohort of psoriasispatients, about 30% of whom had signs of psoriatic arthritis, had shown thatadalimumab improved work ability status. However, this may have been caused inpart by the impact of inflammatory arthritis on function. Here we show thatpsoriasis in the absence of musculoskeletal involvement continues to have a clearimpact on work ability status, and this status is improved by adalimumab treatment.Mean duration of psoriasis-related work absence decreased by over 3 days, while thepercentage of patients with excellent and good workability increased by 14.1%.

interventional study was sponsored by Abbott Germany.

J AM ACAD DERMATOL

P7127Subanalysis of the noninterventional study LOTOS: Patient-oriented out-comes in psoriasis patients treated with adalimumab during routineclinical care

Michaela K€ohm, MD, CIRI/Division of Rheumatology J. W. Goethe-UniversityFrankfurt/Main, Frankfurt am Main, Germany; Frank Behrens, MD, CIRI/Divisionof Rheumatology J. W. Goethe-University Frankfurt/Main, Frankfurt am Main,Germany; Gerd Greger, MD, Abbott Germany, Wiesbaden, Germany; JohannesNorgauer, MD, Department of Dermatology, Friedrich Schiller University Jena,Jena, Germany; Rudolf Schopf, MD, Department of Dermatology/Venerology, J.Gutenberg-University, Mainz, Germany; Sandra Philipp, MD, Charit�eUniversit€atsmedizin Berlin, Department of Dermatology, Venerology andAllergy, Berlin, Germany; Simone Rubant, MD, Abbott Germany, Wiesbaden,Germany

Objective: To evaluate patient-oriented outcomes in patients with moderate tosevere psoriasis treated with adalimumab in routine clinical care and comparedifferent quality of life (QoL) measurements.

Methods: A multicenter, prospective observational study included patients withmoderate to severe psoriasis treated with adalimumab. QoL was measured usingdifferent questionnaires (Dermatology Life Quality Index [DLQI], EuroQol [EQ]-5D,and EQ-VAS). Treatment ratings included questions of treatment burden, timerequired for treatment and the need for assistance on a 5-item scale ranging from‘‘not at all’’ to ‘‘very much.’’ Predictors for therapeutic response were determined bystep-wise regression analysis for changes at 12 months.

Results: Data from 488 patients were analyzed; patients with musculoskeletaldiseases, including psoriatic arthritis, were excluded. The mean age of patients was47.7 years, 68.2% were male, mean disease duration was 21.2 years, and the meanPASI at baseline was 20.9. All QoL questionnaires showed improvements frombaseline to 3 months, and were sustained (EQ-5D) or increased (DLQI and EQ-VAS)through 12 months. DLQI decreased (improved) from 12.0 at baseline to 3.2 atmonth 12, while EQ-VAS increased (improved) from 57.1 to 80.3, respectively. EQ-5D decreased (improved) from 6.6 at baseline to 5.6 at month 12. All items of thetreatment ratings showed significant decreases in the ‘‘very much’’ category andsignificant increases in the ‘‘not at all’’ rating after 6 months of treatment. BaselineDLQI and EQ-VAS, but not EQ-5D, were associated with measures of disease activity(physician’s global assessment [PGA] and body surface area [BSA], respectively).Baseline DLQI and EQ-5D were both associated with impairment of daily activities.High baseline VAS-EQ-5D scores were a positive predictor for improvement at 12months for all QoL measures. Change in disease activity (area under the curve [AUC]for PGA) predicted improvement in DLQI and EQ-VAS at 12months, but EQ-5D at 12months was not associated with changes in disease activity. Older age at diagnosiswas a negative predictor for QoL improvement at 12 months.

Conclusion: All QoL assessments showed an improvement after 3 months oftherapy, supporting the effectiveness of adalimumab in enhancing quality of life inpsoriasis patients. DLQI and EQ-VAS showed significant relationships to diseaseactivity at baseline and to changes in disease activity at 12 months, but EQ-5D didnot.

interventional study was sponsored by Abbott Germany.

P6875Systemic sarcoidosis induced by adalimumab

Josep Pujol-Montcusi, MD, Hospital Universitari Joan XXIII, Tarragona, Spain;Laia Pastor-Jane, MD, Hospital Universitari Joan XXIII, Tarragona, Spain; MariaLuisa Diaz-Fernandez, MD, Hospital Universitari Joan XXIII, Tarragona, Spain;Miguel Lopez-Dupla, MD, Hospital Universitari Joan XXIII, Tarragona, Spain; PilarTuregan-Fuentes, MD, Hospital Universitari Joan XXIII, Tarragona, Spain

Introduction: Tumor necrosis factorealfa (TNF-a) antagonists have been usedeffectively to treat refractory sarcoidosis. Paradoxically, cases of new onset sarcoid-osis-like diseases are increasingly reported in patients receiving TNF-a antagonists.

Case report: A 54-year-old man with a 40-year history of severe chronic plaquepsoriasis, that had been refractory to conventional treatment regimens had beenunder anti-TNF therapy (adalimumab) during 8 months, developed developedsystemic sarcoidosis with pulmonary reticulonodular infiltrates and mediastinal andhilar lymphadenopathy. Two and for months evaluation after adalimumab waswithdrawn, remarkable improvement of the lymphadenopathy and nodules wasevidenced, so steroids therapy was not instituted andwe kept an expectant attitude.

Discussion: Sarcoidosis is a diagnosis of systemic inflammation characterized bynoncaseating granulomas, made after other causes of granulomatoses are excluded.It principally affects the lungs and lymph nodes, but may involve any organs. Themain cytokines responsible for initiation and function of granulomas are TNF-a,interferon-gamma (IFN-g), and interleukin-2. Indeed, TNF-a antagonists have beenused effectively to treat refractory sarcoidosis, so it is somewhat paradoxical thatanti-TNF therapy would cause granulomatosis, but this is a phenomena welldescribed in the recent literature. All 3 currently available TNF-a antagonists(etanercept, adalimumab, and infliximab) have been reported to cause sarcoidosis-like granulomatous reactions. In these cases, a temporal relationship betweenintroduction of TNF-a antagonists and onset of granulomatosis is described, as wellas the improvement when TNF-a antagonists was discontinued. We report thedevelopment of pulmonary sarcoidosis in a patient with severe psoriasis duringadalimumab (TNF-a antagonist) therapy, with significant improvement after 2 and 4months of cessation treatment. There are increasing reports of induced sarcoidosisamong all three anti-TNF agents, suggestive of a ‘‘class effect’’ that was previouslyunderrecognized.

cial support: None identified.

APRIL 2013