DISCUSSION
This real-world analysis described baseline demographics and treatment history of patients with psoriasis who initiated guselkumab during the first year after FDA approval using data from the Symphony Health Claims database. Baseline demographics including mean age and proportion of female patients were generally consistent with findings from other recent real-world studies of patients with psoriasis initiating biologics.8-11 Notably, 63.9% of patients in the present study had at least one claim for another biologic during the year before initiating guselkumab. This finding is slightly lower than rates reported in previous real-world studies of patients initiating the IL-17 inhibitors ixekizumab or secukinumab (66%-88%),8-10 which may reflect differences in study design, data sources, or in the actual proportion of patients initiating these newer agents as first-line biologic therapy.
The most common baseline comorbidities among patients with psoriasis initiating guselkumab were hypertension (25.1%), type 2 diabetes (13.4%), and hyperlipidemia (13.4%), a finding consistent with those of other recent registry and claimsbased studies.8-12 However, the rates of hypertension and hyperlipidemia among patients in the present study are lower than those reported previously, which have ranged from 32.8%- 44.7% and 28.1%-48.6%, respectively.8-12 As noted above, this finding may be associated with differences in the data or patient populations captured by various real-world data sources.
There are several important limitations of this study. As with all claims-based studies, there is a possibility of data omissions or coding errors within the database and the potential for selection bias or sampling error. Furthermore, treatment observations were based on claims for a filled prescription, which does not guarantee actual use of medication(s) by patients. Since the analysis used outpatient pharmacy data, drugs administered in an inpatient hospital setting were not included and those administered in physicians’ offices or facilities may be underrepresented. In addition, the medical claims included in the analysis may be less complete than pharmaceutical data; however, it was assumed that the observations were reflective of population trends even if the absolute values were not. Finally, the dataset did not include information regarding patient insurance eligibility; therefore, proxies were implemented to support assumptions of data completeness.
The most common baseline comorbidities among patients with psoriasis initiating guselkumab were hypertension (25.1%), type 2 diabetes (13.4%), and hyperlipidemia (13.4%), a finding consistent with those of other recent registry and claimsbased studies.8-12 However, the rates of hypertension and hyperlipidemia among patients in the present study are lower than those reported previously, which have ranged from 32.8%- 44.7% and 28.1%-48.6%, respectively.8-12 As noted above, this finding may be associated with differences in the data or patient populations captured by various real-world data sources.
There are several important limitations of this study. As with all claims-based studies, there is a possibility of data omissions or coding errors within the database and the potential for selection bias or sampling error. Furthermore, treatment observations were based on claims for a filled prescription, which does not guarantee actual use of medication(s) by patients. Since the analysis used outpatient pharmacy data, drugs administered in an inpatient hospital setting were not included and those administered in physicians’ offices or facilities may be underrepresented. In addition, the medical claims included in the analysis may be less complete than pharmaceutical data; however, it was assumed that the observations were reflective of population trends even if the absolute values were not. Finally, the dataset did not include information regarding patient insurance eligibility; therefore, proxies were implemented to support assumptions of data completeness.
CONCLUSION
The results of this real-world analysis provide an overview of
the patient demographics and treatment history of patients with
psoriasis who initiated guselkumab during the first year after FDA
approval. These findings provide insights regarding variables
that may impact treatment outcomes and may ultimately help
with treatment decision making. In addition, these findings will
help to inform the design of future assessments of the realworld
effectiveness of guselkumab.
DISCLOSURES
T. Fitzgerald and A. Teeple are employees of Janssen Scientific
Affairs, LLC, and stockholders of Johnson & Johnson, of which
Janssen Scientific Affairs, LLC is a wholly owned subsidiary.
EVERSANA is a paid consultant of Janssen and supported in
the writing and submission of this manuscript. C. Kozma and
T. Slaton received research funding from Janssen Scientific
Affairs, LLC.
ACKNOWLEDGMENT
This study was funded by Janssen Scientific Affairs, LLC. The
authors wish to thank Dr. Ari Mendell, Dana Anger, and Coby
Martin of EVERSANA Value & Evidence for their support in the
development of this manuscript.
REFERENCES
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2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
3. Hawkes JE, Yan BY, Chan TC, Krueger JG. Discovery of the IL-23/IL-17 signaling pathway and the treatment of psoriasis. J Immunol. 2018;201(6):1605-1613.
4. Campa M, Mansouri B, Warren R, Menter A. A review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasis. Dermatol Ther (Heidelb). 2016;6(1):1-12.
5. TREMFYA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2017.
6. Yang EJ, Smith MP, Ly K, Bhutani T. Evaluating guselkumab: an anti-IL-23 antibody for the treatment of plaque psoriasis. Drug Des Devel Ther. 2019;13:1993-2000.
7. Symphony Health. Symphony Health Fact Sheet. Available at: https://s3.useast- 1.amazonaws.com/prahs-symphony-health/resources/Symphony_IDVSheet_ FINAL_JULY.pdf?mtime=20200702132440&focal=none. Accessed October 17, 2020.
8. Blauvelt A, Shi N, Zhu B, et al. Comparison of health care costs among patients with psoriasis initiating ixekizumab, secukinumab, or adalimumab. J Manag Care Spec Pharm. 2019;25(12):1366-1376.
9. Strober B, Karki C, Mason M, et al. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry. J Am Acad Dermatol. 2018;78(2):323-332.
10. Strober BE, Germino R, Guana A, et al. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. J Dermatolog Treat. 2020;31(4):333-341.
11. Shah K, Mellars L, Changolkar A, Feldman SR. Real-world burden of comorbidities in US patients with psoriasis. J Am Acad Dermatol. 2017;77(2):287-292.e284.
12. Feldman SR, Zhao Y, Shi L, Tran MH. Economic and comorbidity burden among patients with moderate-to-severe psoriasis. J Manag Care Spec Pharm. 2015;21(10):874-888.
2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
3. Hawkes JE, Yan BY, Chan TC, Krueger JG. Discovery of the IL-23/IL-17 signaling pathway and the treatment of psoriasis. J Immunol. 2018;201(6):1605-1613.
4. Campa M, Mansouri B, Warren R, Menter A. A review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasis. Dermatol Ther (Heidelb). 2016;6(1):1-12.
5. TREMFYA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2017.
6. Yang EJ, Smith MP, Ly K, Bhutani T. Evaluating guselkumab: an anti-IL-23 antibody for the treatment of plaque psoriasis. Drug Des Devel Ther. 2019;13:1993-2000.
7. Symphony Health. Symphony Health Fact Sheet. Available at: https://s3.useast- 1.amazonaws.com/prahs-symphony-health/resources/Symphony_IDVSheet_ FINAL_JULY.pdf?mtime=20200702132440&focal=none. Accessed October 17, 2020.
8. Blauvelt A, Shi N, Zhu B, et al. Comparison of health care costs among patients with psoriasis initiating ixekizumab, secukinumab, or adalimumab. J Manag Care Spec Pharm. 2019;25(12):1366-1376.
9. Strober B, Karki C, Mason M, et al. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry. J Am Acad Dermatol. 2018;78(2):323-332.
10. Strober BE, Germino R, Guana A, et al. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. J Dermatolog Treat. 2020;31(4):333-341.
11. Shah K, Mellars L, Changolkar A, Feldman SR. Real-world burden of comorbidities in US patients with psoriasis. J Am Acad Dermatol. 2017;77(2):287-292.e284.
12. Feldman SR, Zhao Y, Shi L, Tran MH. Economic and comorbidity burden among patients with moderate-to-severe psoriasis. J Manag Care Spec Pharm. 2015;21(10):874-888.
AUTHOR CORRESPONDENCE
Timothy Fitzgerald PhD MA TFitzg11@ITS.JNJ.com
