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Supplemental Material for Development of Psoriasis Assessment Tools Among Patients in the CorEvitas Psoriasis Registry by Wayne P. Gulliver, Kyoungah See, Baojin Zhu, Bruce W. Konicek, Ryan W. Harrison, Robert R. McLean, Samantha J. Kerti, Russel T. Burge, and Craig L. Leonardi in Journal of Psoriasis and Psoriatic Arthritis

BackgroundThe content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents.ObjectivesTo explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample.MethodsSemi-structured, 90-min, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥ 50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis.ResultsEleven adolescents (aged 12-17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1).ConclusionsThe Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA.

BACKGROUND: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. OBJECTIVE: We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). METHODS: The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient’s skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden’s Index. RESULTS: Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. CONCLUSION: Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.

Peita L Graham-Clarke,1 Brett Hauber,2 Marco Boeri,3 Felice Leonardi,4 Russel T Burge,5 Maria Fernandez,2 Antje Tockhorn-Heidenreich,6 Sandra Florez4,7 1Global Patient Outcomes and Real World Evidence, Eli Lilly Australia, West Ryde, NSW 2114, Australia; 2Health Preference Assessment Group, RTI Health Solutions, Research Triangle Park, NC 27709, USA; 3Health Preference Assessment Group, RTI Health Solutions, Belfast BT2 8LA, UK; 4Eli Lilly Interamerica Inc, Bogotá, Colombia; 5Global Patient Outcomes and Real World Evidence, Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN 46285, USA; 6Global Patient Outcomes and Real World Evidence, Eli Lilly and Co, Erl Wood Manor, Surrey GU20 6PH, UK; 7Pain and Palliative Care Unit, Universidad De La Sabana, Bogotá, ColombiaCorrespondence: Marco BoeriRTI Health Solutions, Forsyth House, Cromac Square Belfast, Belfast BT2 8LA, UKTel +44 (0)161 447 6016Fax +1.919.541.7222Email mboeri@rti.orgPurpose: Teriparatide is used to treat patients with established osteoporosis but is often reserved for patients who have inadequate response to antiresorptive therapy. Biosimilar teriparatide, which is believed to have efficacy and safety similar to the originator product, is now available in Colombia. However, little is known about patients’ preferences for originator biologic and biosimilar treatments. Our objective was to quantify the relative importance that patients in Colombia place on features of injectable osteoporosis treatments including whether the treatment is an originator biologic or a biosimilar.Patients and Methods: We used a discrete choice experiment (DCE) to elicit preferences of patients with osteoporosis treatment devices in Colombia. The survey was completed by 200 respondents at high risk of fracture, with or without teriparatide experience. Each treatment alternative within the DCE was characterized by five attributes: type of medicine (originator biologic, biosimilar), needle length, angle of injection, how to measure the medicine dose, and how long the medicine can be left unrefrigerated. A random parameters logit regression was used to estimate preferences and conditional relative attribute importance, while controlling for preference heterogeneity.Results: A total of 200 patients (mean age = 58.3 years) completed the survey. Most were female (84.5%) and married (54.5%); 50.5% had secondary education or less, 21% had current teriparatide exposure. The attribute with the highest conditional relative importance estimate (standard error) was biologic versus biosimilar (10 [1.11]), followed by needle length (8.06 [1.11]), dose measurement (6.38 [0.87]), refrigeration (3.81 [1.18]), and angle of injection (1.30 [0.66]). Unobserved preference heterogeneity was present and controlled for in the analyses.Conclusion: Despite the availability of biosimilar teriparatide in Colombia, patients expressed a strong preference for an originator biologic osteoporosis medicine over a biosimilar osteoporosis medicine, when the efficacy, safety, and cost of the two options were assumed to be the same.Keywords: discrete choice experiment, injection, devices, teriparatide, fractures

Additional file 1: Figure S1 Associations between different hard-to-treat locations. Table S1 Tests for significant differences. Table S2 EQ-5D-5 L. Table S3 Impact of psoriasis in hard-to-treat areas among patients with mild disease (BSA

Andrew Blauvelt,1 Nianwen Shi,2 Russel Burge,3,4 William N Malatestinic,3 Chen-Yen Lin,3 Carolyn R Lew,2 Nicole M Zimmerman,2 Orin M Goldblum,3 Baojin Zhu,3 Mwangi J Murage3 1Oregon Medical Research Center, Portland, OR, USA; 2IBM Watson Health, Cambridge, MA, USA; 3Eli Lilly and Company, Indianapolis, IN, USA; 4University of Cincinnati, Cincinnati, OH, USACorrespondence: Mwangi J MurageGlobal Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, LCT – South Building 171-2, Drop Code 5221, 1555 Harding St, Indianapolis, IN 46221, USATel +1-317-460-3619Email murage_mwangi_james@lilly.comBackground: There is lack of real-world treatment pattern comparison data between ixekizumab and adalimumab which are approved for the treatment of moderate-to-severe plaque psoriasis.Objective: To compare real-world treatment patterns among psoriasis patients initiating ixekizumab or adalimumab in the United States.Methods: Psoriasis patients with ≥ 1 claim for ixekizumab or adalimumab between March 1, 2016, and May 31, 2018, were identified (index date = date of first ixekizumab or adalimumab claim) from the IBM Watson Health MarketScan® databases. Patients were required to be continuously enrolled for ≥ 12 months before the index date and followed for a minimum of 6 months until inpatient death, enrollment end, or study end, whichever occurred first. Treatment persistence, adherence, discontinuation, restart, and switching were analyzed. Inverse probability of treatment weighting and multivariable regression modeling were employed to address cohort imbalances and estimate the adjusted risk of non-persistence, discontinuation, and switching, and the odds of adherence.Results: A total of 646 ixekizumab and 3668 adalimumab users were included and followed for a mean of 14.0 and 16.5 months, respectively. Compared to adalimumab, ixekizumab was associated with 19% lower risk of non-persistence (hazard ratio [HR]=0.81, 95% confidence interval [CI]: 0.69– 0.95), 26% lower risk of discontinuation (HR=0.74, 95% CI: 0.62– 0.88), and 28% lower risk of switching (HR=0.72, 95% CI: 0.57– 0.91). Ixekizumab users had higher odds of medication possession ratio ≥ 80% (odds ratio [OR]=1.36, 95% CI: 1.10– 1.69) but similar odds by proportion of days covered ≥ 80% (OR=1.22, 95% CI: 0.98– 1.53).Conclusion: Psoriasis patients treated with ixekizumab demonstrated longer persistency, higher adherence and were less likely to discontinue or switch treatment compared to adalimumab users. However, while patients achieving highly adherent threshold significantly differed by MPR ≥ 80%, it did not by PDC ≥ 80%; hence, further analysis using fixed-length follow-up is required.Keywords: ixekizumab, adalimumab, psoriasis, treatment switching, discontinuation, persistence

Objectives: To describe ixekizumab treatment patterns, all-cause healthcare utilization, and costs among psoriasis patients. Methods: Adults diagnosed with psoriasis having ≥1 ixekizumab claim were selected from MarketScan® databases between March 01, 2016 and July 31, 2017. Patients were continuously enrolled for ≥6 months prior and ≥3 months after the index date (first ixekizumab claim) and followed until inpatient death, end of enrollment, or end of data. Treatment patterns included persistence, switching, and re-initiation. All-cause utilization and costs were reported per-patient-per-month (PPPM). Results: 801 patients (mean age 49 years; 55.8% male; median follow-up 201 days) were included. Among all patients, 87.4% were persistent (mean (median) duration 86 (75) days) Of the 12.6% of patients who discontinued ixekizumab, 11.9% re-initiated and 6.9% switched treatments. Mean (median) time to switching was 208 (206) days. Mean number of all-cause inpatient admissions and physician office visits PPPM were 0.01 and 0.72, respectively. Mean total cost PPPM was $8,371, of which pharmacy comprised $7,792. Ixekizumab costs, $7,079, occurred primarily during induction and were paid predominantly by health plans ($6,810 [96.2%]). Conclusion: Most (87.4%) ixekizumab users remained persistent during follow-up. Pharmacy was the primary driver of total healthcare costs, with the majority covered by health plans and

Mwangi J Murage,1 Vanita Tongbram,2 Steven R Feldman,3 William N Malatestinic,1 Cynthia J Larmore,1 Talia M Muram,1 Russel T Burge,1,4 Charles Bay,2 Nicole Johnson,2 Sarah Clifford,5 Andre B Araujo1 1Eli Lilly and Company, Indianapolis, IN, USA; 2ICON Plc, New York, NY, USA; 3Wake Forest University School of Medicine, Winston-Salem, NC, USA; 4University of Cincinnati, Division of Pharmaceutical Sciences, Winkle College of Pharmacy, Cincinnati, OH, USA; 5ICON Plc, San Francisco, CA, USA Purpose: Proper adherence and persistence to medications are crucial for better quality of life and improved outcomes in rheumatoid arthritis (RA), psoriasis (PsO), and psoriatic arthritis (PsA). We systematically describe current adherence and persistence patterns for RA, PsO, and PsA, with a focus on biologics and identifying factors associated with adherence and persistence. Patients and methods: Using various databases, a systematic literature review of US-based studies published from 2000 to 2015 on medication adherence and persistence to biologics and associated factors was conducted among patients with RA, PsO, and PsA. Results: Using the medication possession ratio or the percentage of days covered>80%, RA and PsO adherence rates for etanercept, adalimumab, and infliximab ranged from 16% to 73%, 21% to 70%, and 38% to 81%, respectively. Using the criteria of a ≥45-day gap, RA persistence rates for etanercept, adalimumab, and infliximab ranged from 46% to 89%, 42% to 94%, and 41% to 76%, respectively. In PsO, persistence rates for etanercept and adalimumab ranged from 34% to 50% and 50% to 62%, respectively. Similar persistence rates were observed in PsA. Experienced biologics users showed better adherence and persistence. Younger age, female gender, higher out-of-pocket costs, greater disease severity, and more comorbidities were associated with lower adherence and persistence rates. Qualitative surveys revealed that nonpersistence was partly due to perceived ineffectiveness and safety/tolerability concerns. Conclusion: Biologic adherence and persistence rates in RA, PsO, and PsA in the United States were low, with significant opportunity for improvement. Various factors – including decrease in disease severity; reduction of comorbidities; lower out-of-pocket costs; refilling at specialty pharmacies; and awareness of drug effectiveness, safety, and tolerability – can inform targeted approaches to improve these rates. Keywords: biologics, compliance, nonadherence, nonpersistence, factors, discontinuation

Table S1. E/M Codes. Table S2. Patient perception of treatment effectiveness stratified according to demographic and patient characteristics. Table S3. Demographic and patient characteristics of patients who discontinued treatment. Table S4. Visit frequency during the study period (9/14-9/15) stratified according to maximum sPGA. Table S5. Visit frequency during the study period (9/14-9/15) stratified according to treatment group. Table S6. Annual visit costs stratified according to maximum sPGA. Table S7. Annual visit costs stratified according to treatment. (DOCX 23 kb)

Effect sizes for OPAQ-PF total score change from baseline at 2 weeks (no recent fracture patients) and 12 weeks (recent fracture patients) by Mobility, Physical Positions, and Transfers global ratings of change and change in ratings of concept. (DOCX 169 kb)

Saeko Fujiwara,1 Etsuro Hamaya,2 Masayo Sato,2 Peita Graham-Clarke,3 Jennifer A Flynn,2 Russel Burge41Hiroshima Atomic Bomb Casualty Council, Hiroshima, Japan; 2Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Kobe, Japan; 3Global Health Outcomes, Eli Lilly Australia, Sydney, NSW, Australia; 4Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN,USAPurpose: To systematically review the literature describing the efficacy, effectiveness, and safety of raloxifene for postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia).Materials and methods: Medline via PubMed and Embase was systematically searched using prespecified terms. Retrieved publications were screened and included if they described randomized controlled trials or observational studies of postmenopausal Japanese women with osteoporosis or osteopenia treated with raloxifene and reported one or more outcome measures (change in bone mineral density [BMD]; fracture incidence; change in bone-turnover markers, hip structural geometry, or blood–lipid profile; occurrence of adverse events; and change in quality of life or pain). Excluded publications were case studies, editorials, letters to the editor, narrative reviews, or publications from non-peer-reviewed journals; multidrug, multicountry, or multidisease studies with no drug-, country-, or disease-level analysis; or studies of participants on dialysis.Results: Of the 292 publications retrieved, 15 publications (seven randomized controlled trials, eight observational studies) were included for review. Overall findings were statistically significant increases in BMD of the lumbar spine (nine publications), but not the hip region (eight publications), a low incidence of vertebral fracture (three publications), decreases in markers of bone turnover (eleven publications), improved hip structural geometry (two publications), improved blood–lipid profiles (five publications), a low incidence of hot flushes, leg cramps, venous thromboembolism, and stroke (12 publications), and improved quality of life and pain relief (one publication).Conclusion: Findings support raloxifene for reducing vertebral fracture risk by improving BMD and reducing bone turnover in postmenopausal Japanese women with osteoporosis or osteopenia. Careful consideration of fracture risk and the risk–benefit profile of antiosteoporosis medications is required when managing patients with osteoporosis.Keywords: bone density, fractures, osteoporotic, Japan, osteoporosis, raloxifene