Treatment Changes in PaMents with Moderate-to- Severe Psoriasis: A RetrospecMve Chart Review 4052 Jaclyn A. Smith 1, BS, Brooke Wehausen 1, BS, Irma Richardson 1, MHA, Yang Zhao 4, PhD, Yunfeng Li 4, PhD, Vivian Herrera 4, MPH, Steven R. Feldman 1,2,3, MD, PhD (Please see authors affilia0ons on the last panel) Background Psoriasis treatment involves topical medica0ons, oral medica0ons, phototherapy and/or biologics Treatments used depend on a myriad of factors: character of psoriasis (type and extent),previous treatment experience, efficacy and safety Understanding why psoriasis pa0ents change treatment can help dermatologists becer address their treatment needs Poor efficacy is a main contributor for treatment change 1 The most common reason for stopping oral systemic medica0ons (methotrexate, cyclosporine, and acitre0n) is adverse effects, and the most common reason for stopping biologic medica0ons is loss of efficacy 2-5
Objectives To characterize the frequency of and reasons for treatment changes in pa0ents with moderate-to-severe psoriasis To determining the average number of treatment changes per visit and per year of treatment, number of products used per visit, and the medica0on classes involved in each treatment change 2
Methods A chart review on pa0ents with moderate-to-severe psoriasis seen at the Wake Forest Bap0st Medical Center Department of Dermatology between 01Jan2010 and 30June2015 with at least 1 treatment change Treatment change includes o Switching between medica0on classes o Adding or removing medica0on classes o Switching within the oral or biologic class o Changes only involving a change in topical treatment were not included Medica0on classes o Oral systemic non-biologics o Apremilast o Phototherapy (UVB, PUVA) o Biologics: Etanercept, adalimumab, ustekinumab 3
Variables Age Gender Race/ethnicity Comorbidi0es Reason for treatment change Time since diagnosis Time treated for psoriasis Number of clinic visits over study period Medica0on classes involved in each treatment change 4
Patient Demographics and Clinical Characteristic Total number of patients 116 Mean age, years (mean ± SD 1 ) 53.7 ± 13.5 Age group (%) 18-24 2.0 25-34 7.8 35-44 13.0 45-54 31.0 55-64 25.0 65+ 21.6 Gender (%) Male 43.1 Female 56.9 Ethnicity (%) Caucasian 46.6 African American 6.0 Hispanic 1.7 Not Reported 45.7 Duration with psoriasis (time since diagnosis in years) <10 years 22.4 10-19 years 14.7 20-29 years 11.2 30 years or greater 4.3 Not recorded 47.4 1 Standard devia0on 5
Comorbidities Percent Smoking 12.9 Psoriatic arthritis 12.9 Diabetes mellitus 6.9 Actinic keratosis 5.2 Hypertension 5.2 Alcohol use 5.2 Anxiety 4.3 Obesity 4.3 Osteoarthritis 4.3 6
Treatment Pattern 902 visits by 116 moderate-to-severe psoriasis pa0ents: 7.8 visits/pa0ent o 221 visits with treatment changes o 1 treatment change occurred every 4.1 visits o On average 1.2 treatment changes per year o Pa0ents treated for >1 year averaged 1 treatment change every 16 months o 1.4 treatments used per visit 7
Changes by Drug Class N (%) Non-biologic to non-biologic (other than apremilast) 1 40 (18.1) Non-biologic to biologic 2 30 (13.6) Non-biologic to none 3 15 (6.8) Biologic to non-biologic (other than apremilast) 4 8 (3.6) Biologic to biologic 5 55 (24.9) Biologic to none 6 10 (4.5) Adding combination 7 41 (18.6) Dropping combination 8 8 (3.6) Combination to none 9 2 (0.9) Combination 10 12 (5.4) Total 221 (100) 1 Non-biologic to non-biologic (other than apremilast): A pa0ent was on a non-biologic and had a non-biologic added to or replacing previous medica0ons. 2 Non-biologic to biologic: A pa0ent was on a non-biologics and had a biologic added to or replacing their previous medica0ons. 3 Non-biologic to none: A pa0ent was on a non-biologic and it was discon0nued, leaving the pa0ent on no treatment. 4 Biologic to non-biologic (other than apremilast): A pa0ent was on a biologic that was discon0nued and the pa0ents remained on only a non-biologic. 5 Biologic to biologic: A pa0ent was on a biologic that was discon0nued and replaced with a different biologic. 6 Biologic to none: A pa0ent was on at least a biologic and everything was discon0nued. 7 Adding combina0on: A pa0ent was on a biologic medica0on and a non-biologic was added. Combina0on was defined as a pa0ent being on at least one biologic and one non-biologic. 8 Dropping combina0on: A pa0ent was on a combina0on treatment and the non-biologic treatment was discon0nued, so that the pa0ent only remained on the biologic treatment. Dropping the biologic in this situa0on would be biologic to non-biologic. 9 Combina0on to none: A pa0ent was on combina0on treatment and everything was discon0nued. 10 Combina0on: A pa0ent was on a combina0on treatment and a non-biologic was added or replaced the original non-biologic, but the pa0ent remained on combina0on treatment before AND ager the treatment change. 8
Reasons for Treatment Change Changes by drug class Flare up/poor control Patient preference Reason for Change Afford ability Side effect Well controlled Psoriatic arthritis All changes* 126 30 25 21 19 13 All changes with non-biologics 51 23 4 14 16 5 All changes with biologics 75 7 21 7 3 8 Non-biologic to non-biologic 1, ** 24 8 0 6 2 1 Non-biologic to biologic 2 23 1 2 3 0 3 Non-biologic to none 3 2 7 1 2 6 0 Biologic to non biologic 4,** 1 1 5 1 0 0 Biologic to biologic 5 36 2 8 5 0 5 Biologic to none 6 1 3 5 1 1 0 Adding combination 7 37 0 2 0 1 3 Dropping combination 8 1 3 0 0 5 0 Combination to none 9 0 1 1 0 1 0 Combination 10 1 4 1 3 3 1 The most common reason for treatment change for each drug class is bolded, and the 2 nd most common reason is underlined. * The total number is larger than the number of visits with treatment changes since some pa0ents had two reasons listed for medica0on adjustments. ** Other than apremilast. 1 Non-biologic to non-biologic: A pa0ent was on a non-biologic and had a non-biologic added to or replacing previous medica0ons. 2 Non-biologic to biologic: A pa0ent was on a nonbiologics and had a biologic added to or replacing their previous medica0ons. 3 Non-biologic to none: A pa0ent was on a non-biologic and it was discon0nued, leaving the pa0ent on no treatment. 4 Biologic to non-biologic: A pa0ent was on a biologic that was discon0nued so that they either remained on only a non-biologic. 5 Biologic to biologic: A pa0ent was on a biologic that was discon0nued and replaced with a different biologic. 6 Biologic to none: A pa0ent was on at least a biologic and everything was discon0nued. 7 Adding combina0on: A pa0ent was on a biologic medica0on and a non-biologic was added. Combina0on was defined as a pa0ent being on at least one biologic and one non-biologic. 8 Dropping combina0on: A pa0ent was on a combina0on treatment and the non-biologic treatment was discon0nued, so that the pa0ent only remained on the biologic treatment. (Dropping the biologic in this situa0on would be biologic to nonbiologic.) 9 Combina0on to none: A pa0ent was on combina0on treatment and everything was discon0nued. 10 Combina0on: A pa0ent was on a combina0on treatment and a non-biologic was added or replaced the original non-biologic, but the pa0ent remained on combina0on treatment before AND ager the treatment change. 9
Limitations By not including treatment changes involving only topicals, we underes0mate the treatment change rate in pa0ents with moderate-severe psoriasis 10
Conclusions Biologic treatment op0ons provide a major improvement over older systemic treatments, but pa0ents s0ll undergo 1.2 treatment changes per year, roughly once in every 3 visits, to help control their disease References 1. Anderson KL, Feldman SR. Reasons for Treatment Changes in Pa0ents With Moderate to Severe Psoriasis. J Cutan Med Surg 2015 2015 Jul-Aug;19(4):361-6. 2. Levin AA, GoClieb AB, Au SC. A comparison of psoriasis drug failure rates and reasons for discon0nua0on in biologics vs conven0onal systemic therapies. J Drugs Dermatol 2014 Jul;13(7):848-53. 3. Due E, Blomberg M, Skov L, Zachariae C. Discon0nua0on of methotrexate in psoriasis. Acta Derm Venereol 2012 Jul;92(4): 353-4. 4. Gniadecki R, Bang B, Bryld LE, Iversen L, Lasthein S, Skov L. Comparison of long-term drug survival and safety of biologic agents in pa0ents with psoriasis vulgaris. Br J Dermatol 2015 Jan;172(1):244-52. 5. Gniadecki R, Kragballe K, Dam TN, Skov L. Comparison of drug survival rates for adalimumab, etanercept and infliximab in pa0ents with psoriasis vulgaris. Br J Dermatol 2011 May;164(5):1091-6. Author affiliamons Center for Dermatology Research, Departments of 1 Dermatology, 2 Pathology and 3 Public Health Sciences; Wake Forest School of Medicine, Winston-Salem, North Carolina 4 Novar0s Pharmaceu0cals Corpora0on, East Hanover, NJ 07936 Disclosures Sponsor or funding source: Novar0s Dr. Steven R. Feldman has received consul0ng, speaking and/or research support from Abbvie, Amgen, Celgene, Galderma, Janssen, Lilly, Merck, Mylan, Novar0s, Pfizer and Taro. Dr. Steven R. Feldman is the founder and holds stock in Causa Research. Yang Zhao, Yunfeng Li, and Vivian Herrera are employed by Novar0s Pharmaceu0cals Corpora0on. Jaclyn Smith, Brooke Wehausen, and Irma Richardson have no conflicts to disclose. 11
Thank you! Correspondence: Jaclyn Smith Jaclynsmith@ufl.edu 12