Case Questions
- What therapeutic option would you select next for this patient?
- Would you select another IL-23 inhibitor or an agent from another class?
- What major factors drive your therapeutic decision-making?
Noor first reviewed with attendees the current therapeutic landscape in psoriasis and what options are available for clinicians to prescribe:
- IL-23 inhibitors: tildrakizumab, risankizumab, guselkumab
- IL-12/-23 inhibitors: ustekinumab
- IL-17 inhibitors: bimekizumab, secukinumab, brodalumab, ixekizumab
- TNF-α inhibitors: certolizumab, etanercept, adalimumab, infliximab
Real-World Studies
To determine the best therapeutic option for this patient, Noor reviewed the efficacy of another IL-23 inhibitor, tildrakizumab (Ilumya; Sun Pharma), in examples of real-world studies. First, a study conducted by Burlando et al evaluated 26 patients with moderate to severe psoriasis who had a BSA of 10% or more, a Physician Global Assessment (PGA) score of 3 or higher, a Psoriasis Area and Severity Index (PASI) score of 12 or higher at baseline. In addition, 80.8% of the patients had received previous biologic therapy.
In Burlando’s study, 71% of patients(17/24) treated with tildrakizumab100mgat weeks 0 and 4, then every 12 weeks thereafter, achieved PASI 90 after 12 weeks. After 24 weeks, 91% (21/23) of patients achieved PASI 90. PASI 100 was reached by 67% (16/24) of patients treated with tildrakizumab after 12 weeks and 87% (20/23) after 24 weeks. Treatment with tildrakizumab improves PGA and Dermatology Life Quality Index(DLQI) scores.1
A second study by Wei et al evaluated 30 patients with moderate to severe psoriasis, 40% of which had received previous biologic therapy. Overall, 60% (n= 18) of patients were biologic naive, and 6.7% (n= 2) had been treated with only apremilast (Otezla; Amgen). After 12 months of treatment with tildrakizumab at weeks 0 and 4, then every 12 weeks thereafter, 83% of biologic-naive patients achieved PASI 90 and 39% achieved PASI 100, respectively. For patients previously treated with biologics, 33% achieved PASI 90, and 25% achieved PASI 100 after 12 months.2
Case Questions
- How do the data on PASI 90 and PASI 100 scores frame your decision-making in practice?
- What quality of life and patient-reported outcome data stand out most?
- How do these data impact how you discuss treatment options with patients?
In a review by Costanzo et al of the phase 4 TRIBUTE study (NCT04229836), investigators assessed the efficacy and impact on health-related quality of life of tildrakizumab 100mg in adults with moderate to severe psoriasis who were naive to IL-23/Th17 pathway inhibitors in conditions similar to clinical practice. After 24 weeks, the proportion of patients achieving PASI scores of 3 or less, PASI 75, PASI 90, and DLQI 0/1 was 88.4%, 92.5%, 74.0%, and 70.4%, respectively. Overall, tildrakizumab demonstrated significant improvements in pruritus, pain, and sleep scores.3
Treatment Decision
Case Questions
- How might alternative care sites provide greater access to biologic treatments for patients who otherwise face coverage barriers?
- How can providers effectively communicate with patients about using alternative care sites?
- How might infusion centers help improve treatment adherence for patients with high BSA involvement?
- What are the pros and cons of administering injections in office using buy-and-bill vs referring patients to infusion centers?
- What factors should be considered regarding the financial and logistical aspects of the buy-and-bill approach for Medicare patients?
- What factors determine the reimbursement rates for physicians administering injections in office under the buy-and-bill model?
In Noor’s presented case, after considering the patient’s treatment history and difficulty maintaining adherence, the clinician decided to initiate tildrakizumab 100mg subcutaneously at weeks 0 and 4, and every 12 weeks thereafter. Noor discussed with attendees the benefits of alternative care sites such as infusion centers, which can benefit Medicare patients with secondary insurance. Additionally, the buy-and-bill model may financially benefit physicians because better prices can be negotiated. However, it can also be burdensome to manage inventory and financial risk.
After receiving tildrakizumab, the patient felt comfortable and adhered to the scheduled dosing. He had no safety issues and had decreased BSA and reduced symptoms at 3 months.
References
- Burlando M, Castelli R, Cozzani E, Parodi A. Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting. Drugs Context. 2021;10:2021-2-6. doi:10.7573/dic.2021-2-6
- Wei NW, Chi S, Lebwohl MG. Retrospective analysis in patients with moderate to severe plaque psoriasis treated with tildrakizumab: real-life clinical data. J Psoriasis Psoriatic Arthritis. 2022;7(2):55-59. doi:10.1177/24755303221077211
- Costanzo A, Llamas-Velasco M, Fabbrocini G, et al. Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. J Eur Acad Dermatol Venereol. 2023;37(10):2004-2015. doi:10.1111/jdv.19229