Marissa Nahirney, BHSc1; Matthew Hum, MD, CCFP2; Pamela Mathura, MBA3; Marlene Dytoc, MD, PhD, FRCPC4
1Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
2Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada
3Department of Medicine, Alberta Health Services, University of Alberta, Edmonton, AB, Canada
4Division of Dermatology, University of Alberta, Edmonton, AB, Canada
Conflict of interest:
All of the authors declare no potential conflicts of interest with respect to their research, authorship and/or publication of this article.
Funding Sources:
None.
Abstract:
Although biologics are well-studied, expertise regarding their use is often lacking. Many biologics have been added to the market in recent years with distinctive characteristics. This study was designed to create a tool to assist physicians involved in the care of patients with psoriasis undergoing biologic treatment. We used a quality improvement approach to develop and trial an educational visual aid to deliver comprehensive information about biologics in a convenient manner. As a pilot study, trialing this tool was carried out on a small scale to test the feasibility of both the study design and the visual aid itself, with 8 physician and 8 patients completing questionnaires evaluating the visual aid. From our results, the tool was helpful for improving patient knowledge of biologic treatment and their engagement in clinical decision-making. This visual aid may serve as a central convenient biologic
resource for physicians.
Key Words:
psoriasis, biologics, patient education, shared decision-making
Introduction
Biologics are a class of drugs that are often used to treat moderate to severe psoriasis. Approximately 1 million Canadians are affected by psoriasis and of those, 39.9% are treated with biologics.1 As new biologics continue to enter the market, understanding the unique characteristics of each drug in this therapeutic class is a complicated endeavor. The authors undertook this study with the primary objective of evaluating the extent to which an educational visual aid of biologics could aid dermatologists in counseling their patients during treatment planning. The biologic handout that was created for this study is the main deliverable which we aim to circulate widely, as a means of encouraging shared decision-making and transparency of pharmaceutical options. Our secondary objective was to identify the factors that physicians consider important in their choice of biologics.
Methods
Our investigation used a pragmatic quality improvement (QI) research approach as it provides a systematic inquiry that generates actionable knowledge aimed at improving the delivery of patient care.2 This study employed the Model of Improvement, which provided our study with a roadmap for knowledge translation to developed actions, where through an experimentation (Plan-Do Study-Act, PDSA) cycle and practical experience leads to continuous improvement.3 A PDSA cycle is a systematic approach to planning an intervention, assessing its impact, and proceeding with another cycle of implementation after improvements have been made.3,4
With the goal of developing a clinical teaching tool, we consolidated information on biologics available to patients in Canada as of December 2019 (Table 1).
Once consent was obtained from dermatologists and senior dermatology residents, they completed a questionnaire to determine general preferences and reasons for prescribing biologics. Clinicians then used the educational tool to discuss treatment options with their psoriatic patients. After 3 months of use, physicians completed a post-implementation questionnaire. The patients were also provided with an anonymous questionnaire at the end of the visit.
Descriptive statistics were used to understand the characteristics affecting dermatologists’ biologic prescribing preference.5 We used bar graphs to visually determine the factors that dermatologists prioritize when prescribing biologics, as well as the post-implementation data collected from patients about the utility of the visual aid for their involvement in decision-making. Weighted means were calculated for physician biologic preferences at baseline and after 3 months of visual aid use, assigning a score of 5 to each physician’s most-preferred treatment, and 1 for the least-preferred. This project was approved by the Research Ethics Board at the University of Alberta (Pro00091432).
Table 1: Original visual aid describing characteristics of 11 biologics and 1 small molecule phosphodiesterase 4 inhibitor (i.e., apremilast)
Results
Eight dermatologists and residents consented to participate. Of those physicians, 3 completed the post-visual aid questionnaire. Eight patients consented and completed their questionnaire during implementation. All questionnaires were completed anonymously. The participating physicians prescribed biologics to their patients at baseline, initiating approximately 2-3 patients with this treatment modality per month.
At baseline, the biologics, in order of frequency of prescribing, were: 1) secukinumab, 2) guselkumab, and 3) ustekinumab. The main factors affecting choice of biologic were co-morbidities (n=8, 100%), efficacy (n=7, 87.5%), and contraindications (n=7, 87.5%) (Figure 1). Fifty percent of physicians were familiar with the relative costs of each biologic (n=4), and 75% felt they were not adequately informed about the cost of biologics (n=6).
Figure 1: Physician responses to factors affecting dermatologists’ choice of biologic
After 3 months of use, the ‘study’ portion of the PDSA cycle was initiated with the administration of the post-aid questionnaire to the physicians. Post-implementation, the most popular biologics were 1) guselkumab, 2) risankizumab, and 3) ixekizumab. The physician respondents reported no significant impact of the visual aid on their choice of biologics, although (n=2, 66.5%) found the visual aids slightly useful. One physician commented that the visual aids “helped with listing the adverse effects and to show efficacy, not so much to compare biologics.” Patients were asked to complete their questionnaire at the end of physician visual aid use. Generally, patients felt there was no significant impact (n=5, 62.5%) on their choice of biologic. There was a mixed response regarding the frequency that physicians used visual aids during clinic appointments in general (Figure 2). Some participants noted that the decision was still largely made by the physician, regardless of the use of the visual aid for patient education. However, there was a greater proportion of patients who indicated that the visual aids were either somewhat (n=4, 50%) or very (n=3, 37.5%) useful in explaining treatment options to them (Figure 2).
Figure 2: Patient responses to visual aid education use and physician interactions
Discussion
The purpose of this quality improvement project was to advance patient education by using a visual aid. The results of the preand post-implementation questionnaires suggest that the visual aid is best suited to informing patients. The visual aid itself had minimal impact on therapeutic decision-making.
For future iterations of a PDSA cycle, we simplified the visual aid (Table 2). Terminology was changed to improve clarity; the list of adverse reactions was reduced to common adverse reactions (frequency greater than 10%) and efficacy reported as two figures (primary outcome and maintenance outcome). In future studies, it would be prudent to consider patient education in the dynamic of the patient-physician relationship. Some studies have noted that patients feel their role is to simply accept decisions made by physicians.6,7 Shared decision-making has been shown to be inhibited by patient feelings, as they may be uncomfortable to raise concerns.4,6,7 Additionally, as patients may feel ill-equipped to be involved in care decisions, physician expertise is perceived as most important.7 As opposed to highly detailed product monographs, a visual aid may allow patients to glean details with a glance. Therefore, incorporating patient education through visual aids has the potential to promote increased dialogue with their care provider, thereby encouraging adherence and satisfaction with their care plan.
A major limitation of this investigation was the small sample sizes, as it is difficult to estimate the true impact on larger populations. In particular, the poor reuptake by physicians post-implementation greatly limits our ability to judge how the visual aid would be used on a longer timescale. While physicians may initially be open to using the tool, an important consideration would be to know whether the visual aid added benefit to physicians’ clinic encounters sufficiently in order to continue use on a routine basis. In future trials, rather than providing anonymous surveys, we plan to conduct focus groups to allow for improved follow-up as well as open discussion about the tool’s utility. Overall, the visual aid was appreciated by physicians as an educational aid tool that helped to facilitate conversations, therefore, there is merit in further developing and studying its benefits in the clinic setting. Similarly, patients noted that the visual aid was helpful for better understanding the selected treatment. General feedback from physicians were that the visual aid appeared content dense due to the high amount of information provided. For future iterations of a PDSA cycle, we plan on simplifying the visual aid for patients, while maintaining the key components of indication, adverse events, efficacy, and contraindications.
Table 2: Revised visual aid describing characteristics of 11 biologics approved by Health Canada between 2000-2019
Conclusion
Counseling patients to start biologics is a complex task. As medicine is moving towards empowering patients, presenting a large amount of information about biologics may be intimidating to them. Our study suggests that the use of a visual aid may help patients better retain information during counseling and reduce anxiety and uncertainty when starting biologic treatment. This visual aid may also be useful for dermatologists, wherein the consolidated information will allow them to compare biologic options, in addition to promoting open communication with patients about treatment options. Developing tools to facilitate patient satisfaction in an otherwise daunting clinical experience may contribute to better patient outcomes.
References
- Canadian Association of Psoriasis Patients, Canadian Psoriasis Network. Psoriasis: journey to stability – national report: Canadians’ journey living with psoriasis. Winter 2018. Available at: https://communautepsoriasis.ca/images/ pdfs/Psoriasis_Journey_to_Stability_Report_FINAL.pdf. Accessed October 3, 2021.
- Olds D, Øvretveit J. Innovations in quality improvement research for more useful answers to research users’ questions. Implementation Science. 2013 April;8(1):S7.
- Berwick DM. A primer on leading the improvement of systems. BMJ. 1996 Mar 9;312(7031):619-22.
- Doherty C, Doherty W. Patients’ preferences for involvement in clinical decision-making within secondary care and the factors that influence their preferences. J Nurs Manag. 2005 Mar;13(2):119-27.
- Plichta SB, Kelvin EA. Munro’s statistical methods for health care research, 6th ed. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2013.
- Thompson AG. The meaning of patient involvement and participation in health care consultations: a taxonomy. Soc Sci Med. 2007 Mar;64(6):1297-310.
- Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns. 2014 Mar;94(3):291-309.
- HUMIRA® (adalimumab) [prescribing information]. AbbVie Inc. North Chicago, IL. Revised February 2021. Available at: https://www.rxabbvie.com/pdf/humira.pdf. Accessed October 3, 2021.
- Crowley JJ, Weinberg JM, Wu JJ, et al, National Psoriasis Foundation. Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation. JAMA Dermatol. 2015 Jan;151(1):87-94.
- Fotiadou C, Lazaridou E, Sotiriou E, et al. Scalp psoriasis and biologic agents: a retrospective, comparative study from a tertiary psoriasis referral centre. J Eur Acad Dermatol Venereol. 2016 Dec;30(12):2091-6.
- Leonardi C, Langley RG, Papp K, et al. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36.
- Whitlock SM, Enos CW, Armstrong AW, et al. Management of psoriasis in patients with inflammatory bowel disease: From the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2018 Feb;78(2):383-94.
- Porter ML, Lockwood SJ, Kimball AB. Update on biologic safety for patients with psoriasis during pregnancy. Int J Womens Dermatol. 2017 Mar;3(1):21-5.
- Feagan BG, Sandborn WJ, D’Haens G, et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-tosevere Crohn’s disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017 Apr 29;389(10080):1699-709.
- Canadian Agency for Drugs and Technologies in Health Common Drug Review. Pharmacoeconomic review report: brodalumab (SILIQ). Published July 2018. Available at: https://www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/SR0547_Siliq_PE_Report.pdf. Accessed October 3, 2021.
- Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51.
- Gordon KB, Langley RG, Leonardi C, et al. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study. J Am Acad Dermatol. 2006 Oct;55(4):598-606.
- CIMZIA® (certolizumab pegol) . UCB Canada Inc., Oakville, ON. Revised November 13, 2019. Available at: https://ucb-canada.ca/sites/default/files/2021-03/2019-11-13%20cimzia-pm-en.pdf. Accessed October 3, 2021.
- Canadian Agency for Drugs and Technologies in Health Common Drug Review. Pharmacoeconomic review report: certolizumab pegol (CIMZIA). Published September 2017. Available at: https://www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/SR0385_CimziaAS_PE_Report_e.pdf. Accessed October 3, 2021.
- Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-76 e5.
- Gottlieb AB, Blauvelt A, Thaci D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-14 e6.
- ENBREL® (etanercept) . Revised March 19, 2021. Amgen Canada Inc. (for Immunex Corporation), Mississauga, ON. Available at: https://www.amgen.ca/products/~/media/5d0a40b2b8774fb5994190f97daf7fbd.ashx. Accessed October 3, 2021.
- Tyring S, Gordon KB, Poulin Y, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26.
- REMICADE® (infliximab) . Revised April 1, 2021. Janssen Inc., Toronto, ON. Available at: https://www.janssen.com/canada/sites/www_janssen_com_canada/files/prod_files/live/remicade_cpm.pdf. Accessed October 3, 2021.
- Di Lernia V, Guareschi E. Successful treatment of hand and foot psoriasis with infliximab. Dermatol Online J. 2010 Jul 15;16(7):8.
- Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007 Jan;56(1):31 e1-15.
- Takahashi H, Tsuji H, Ishida-Yamamoto A, et al. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol. 2013 Jan;40(1):39-42.
- Torii H, Sato N, Yoshinari T, et al. Dramatic impact of a Psoriasis Area and Severity Index 90 response on the quality of life in patients with psoriasis: an analysis of Japanese clinical trials of infliximab. J Dermatol. 2012 Mar;39(3):253-9.
- INFLECTRA® (infliximab) . Revised August 24, 2018. Pfizer Canada Inc. (for Celltrion Healthcare Co., Ltd.), Kirkland, QC. Available at: https://www.pfizer.ca/sites/g/files/g10050796/f/201809/INFLECTRA_PM_E_218146_24Aug2018.pdf. Updated 2018. Accessed October2 3, 2021.
- SILIQ™ (brodalumab) . Revised March 1, 2018. Valeant Canada LP, Laval, QC. Available at: https://pdf.hres.ca/dpd_pm/00044076.PDF. Accessed October 3, 2021.
- Farahnik B, Beroukhim K, Abrouk M, et al. Brodalumab for the treatment of psoriasis: a review of phase III trials. Dermatol Ther (Heidelb). 2016 Jun;6(2):111-24.
- Papp K, Leonardi C, Menter A, et al. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-90 e3.
- TALTZ™ (ixekizumab) . Revised March 29, 2018. Eli Lilly Canada Inc., Toronto, ON. Available at: https://pdf.hres.ca/dpd_pm/00044542.PDF. Accessed October 3, 2021.
- Beck KM, Yang EJ, Sanchez IM, et al. Treatment of genital psoriasis: a systematic review. Dermatol Ther (Heidelb). 2018 Dec;8(4):509-25.
- COSENTYX® (secukinumab) [prescribing information]. Revised May 2021. Novartis Pharmaceuticals Corporation, East Hanover, NJ. Available at: https:// www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/cosentyx.pdf. Accessed October 3, 2021.
- Paul C, Reich K, Gottlieb AB, et al. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5.
- Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9.
- Blauvelt A, Reich K, Tsai TF, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-9 e9.
- TREMFYA® (guselkumab) . Revised September 4, 2020. Janssen Inc., Toronto, ON. Available at: https://www.janssen.com/canada/sites/www_janssen_com_canada/files/prod_files/live/tremfya_cpm.pdf. Accessed October 3, 2021.
- Machado A, Torres T. Guselkumab for the treatment of psoriasis. BioDrugs. 2018 Apr;32(2):119-28.
- Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017 Mar;76(3):405-17.
- STELARA® (ustekinumab) . Revised October 14, 2020. Janssen Inc., Toronto, ON. Available at: https://www.janssen.com/canada/sites/www_janssen_com_canada/files/prod_files/live/stelara_cpm.pdf. Accessed October 3, 2021.
- Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumabcontrolled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-61.
- SKYRIZI® (risankizumab) . Revised August 19, 2021. Abbvie Corporation, St-Laurent, QC. Available at: https://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/SKYRIZI_PM_EN.pdf. Accessed October 3, 2021.
- OTEZLA® (apremilast) . Revised August 5, 2020. Amgen Canada Inc., Mississauga, ON. Available at: https://media.celgene.com/content/uploads/sites/23/Otezla-Product-Monograph-English.pdf. Accessed October 3, 2021.
- Rich P, Gooderham M, Bachelez H, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatol. 2016 Jan;74(1):134-42.
- Papp K, Cather JC, Rosoph L, et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46.
- Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015 Jul;73(1):37-49.
- Canadian Agency for Drugs and Technologies in Health Common Drug Review. Subsequent entry biologic review report: infliximab (INFLECTRA). Published November 2017. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534737/pdf/Bookshelf_NBK534737.pdf. Accessed October 3, 2021.References