Biosimilars Play Growing Role in Psoriasis Treatment Strategies

Publication
Article
Pharmacy TimesMay 2024
Volume 90
Issue 5

These options are typically more cost-effective, enhancing patient accessibility

Psoriasis is a chronic autoimmune condition driven by an overactive immune system that causes the accelerated production of skin cells, leading to inflamed, thickened patches of skin. It impacts over 3% of adults in the US, which equates to more than 7.5 million individuals.1 Although the exact etiology of psoriasis remains elusive, several factors are recognized as contributors to its onset. For example, psoriasis is influenced by genetic predisposition, as individuals with a family history of the condition face a heightened risk of developing it.

Close-up woman touches herself. Neck, back, spine. Psoriasis skin, eczema, rash and other skin diseases. A woman hides her face, she is ashamed of her autoimmune genetic disease - Image credit: stockmaster | stock.adobe.com

Image credit: stockmaster | stock.adobe.com

Psoriasis manifests in various forms, including plaque psoriasis, guttate psoriasis, pustular psoriasis, and erythrodermic psoriasis, each with distinct clinical presentations and severity.2 Beyond its physical symptoms, psoriasis can have a profound impact on patients’ quality of life, affecting their emotional well-being, social interactions, and self-esteem. Exacerbations can be triggered by several factors, such as infections, physical or emotional stressors, environmental triggers, discontinuation of systemic corticosteroids, alcohol consumption, smoking, and skin injuries.2

TREATMENT APPROACHES

In addressing the importance of effective treatment modalities, it is crucial to consider both nonpharmacologic interventions and pharmacologic approaches. Treatment for psoriasis typically follows a severity-based algorithm, ensuring appropriate management tailored to the individual’s needs. The severity of psoriasis is often categorized as mild, moderate, or severe, based on factors such as the extent of skin involvement, presence of comorbidities, and impact on quality of life.

In mild cases, topical therapies such as corticosteroids, vitamin D analogues, and calcineurin inhibitors are often sufficient to control symptoms and manage flare-ups. For moderate to severe psoriasis, systemic therapies such as oral medications (eg, methotrexate, acitretin), phototherapy, or biologic agents may be necessary.3

About the Author

Anjeza Fero, PharmD, RPh, is a pharmacist and professor in the Department of Physiology and Neurobiology at the University of Connecticut in Storrs.

It is important to follow a structured algorithm that ensures systematic assessment and progression to advanced therapies like biologics and biosimilars when necessary. However, the selection of treatment should be tailored to each patient’s needs, considering factors such as disease severity and patient preferences.

Additionally, close monitoring and regular follow-up are essential to assess treatment response and tolerability.

ROLE OF BIOSIMILAR DRUGS IN PSORIASIS

Biosimilars are designed to closely resemble already-approved biological drugs, commonly referred to as reference biologics. They have comparable efficacy, safety, and immunogenicity profiles to the reference product. In treating psoriasis, biosimilars target key cytokines involved in the inflammatory cascade, such as tumor necrosis factor-α (TNF-α), IL-17, or IL-23.4 Table 1 reviews some biosimilar options available for the treatment of moderate to severe psoriasis.

Although biosimilars are similar to reference biologics, they are typically more cost-effective than reference biologics, which enhances patient accessibility. Additionally, clinical studies have shown similar effectiveness and safety between biosimilars and reference biologics in psoriasis treatment. On the other hand, both biologics and biosimilars impose a risk of immunogenicity, which can potentially lead to treatment failure. There are also limited long-term safety and efficacy data compared to reference biologics due to biosimilars’ shorter market presence.5

EVIDENCE-BASED STUDIES: SAFETY AND EFFICACY IN PSORIASIS TREATMENT

A study comparing MSB11022, a biosimilar of adalimumab (Humira; AbbVie), with the reference product in patients with moderate to severe plaque psoriasis yielded significant findings. Overall, both MSB11022 and the reference product demonstrated similar efficacy, safety, and immunogenicity profiles.6 Patients treated with MSB11022 showed improvements in psoriasis symptoms, such as a reduction in Psoriasis Area and Severity Index (PASI) scores, comparable to those treated with the reference product adalimumab. Additionally, the incidence of adverse events and immunogenicity rates were similar between the 2 treatment groups. These findings suggest that MSB11022 is a viable alternative to the reference product adalimumab for the treatment of moderate to severe plaque psoriasis, providing patients and health care providers with more effective treatment options.

In another study comparing infliximab and its biosimilar CT-P13 in patients with psoriasis vulgaris, a comparative analysis was conducted to evaluate the safety profile and adverse effects of both medications. The methods involved assessing the incidence and severity of adverse events experienced by patients receiving either infliximab or CT-P13 treatment. The results showed comparable safety profiles between infliximab and its biosimilar CT-P13 in patients with psoriasis vulgaris.7 No significant differences were observed in the incidence or severity of adverse events between the 2 treatment groups. Table 25 reviews common adverse effects of biosimilar treatments in psoriasis.

IMMUNOGENICITY CONCERNS AND THEIR IMPLICATIONS Immunogenicity occurs when a biologic medication, including biosimilars, triggers an immune response in the body, resulting in the formation of antidrug antibodies. This process can affect the effectiveness, safety, and long-term outcomes of psoriasis treatment.8

Implications of immunogenicity in biosimilar therapy for psoriasis include the following:

  • Reduced treatment efficacy: Antidrug antibodies may neutralize the therapeutic effects, potentially worsening the condition.
  • Safety concerns: Immunogenicity can increase the risk of adverse events such as infusion reactions and autoimmune phenomena.
  • Treatment durability: Persistent immunogenicity may require adjustments to the treatment plan, including dose changes or a switch to other therapies.

SWITCHING TREATMENTS

Switching from one therapy to another may be considered to potentially improve efficacy, safety, or tolerability between biosimilar agents. However, it is important to note that not all switches may result in improvement, and there are not enough data to provide specific recommendations at this time.9

There are no evidence-based guidelines on the duration between discontinuation of the previous medication and initiation of a new biologic. The timing may vary depending on factors such as the treatment being discontinued, disease severity, response to prior treatment, and provider opinion. Providers should use their clinical judgment and make decisions on a case-by-case basis.

Provider assessment tools for evaluating psoriasis severity include the following:

  • The PASI, which assesses the extent and severity of psoriatic lesions
  • The Dermatology Life Quality Index, which measures the impact of psoriasis on a patient’s quality of life
  • The Physician Global Assessment, which provides a clinician’s overall evaluation of disease severity
  • The Psoriasis Symptom Inventory, which has patient-reported outcome measures that assess symptom severity and impact on daily life10

The management of psoriasis encompasses a diverse array of treatment modalities tailored to individual needs. Biosimilars offer a cost-effective alternative with comparable efficacy to reference biologics, expanding treatment options for patients. However, it is essential to keep in mind potential adverse events associated with biosimilar therapy and to closely monitor patients for any treatment-related complications. Clinicians must remain vigilant in assessing treatment response and adjusting therapy as needed. Moving forward, ongoing research and attentive monitoring will play a critical role in maximizing the effectiveness of biosimilar therapy and improving outcomes for individuals with psoriasis.

REFERENCES
1. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis prevalence in adults in the United States. JAMA Dermatol. 2021;157(8):940-946. doi:10.1001/jamadermatol.2021.2007
2. Raharja A, Mahil SK, Barker JN. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257
3. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Derm. 2019;81(3):775-804. doi:10.1016/j.jaad.2019.04.042
4. Menter A, Krueger GG, Paek SY, Kivelevitch D, Adamopoulos IE, Langley RG. Interleukin-17 and interleukin-23: a narrative review of mechanisms of action in psoriasis and associated comorbidities. Dermatol Ther (Heidelb). 2021;11(2):385-400. doi:10.1007/s13555-021-00483-2
5. Ahmed SS, De A, Das S, Manchanda Y. Biologics and biosimilars in psoriasis. Indian J Dermatol. 2023;68(3):282-295. doi:10.4103/ijd.ijd_421_23
6. Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol. 2020;182(2):316-326. doi:10.1111/bjd.18220
7. Morita A, Nishikawa K, Yamada F, Yamanaka K, Nakajima H, Ohtsuki M. Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis. J Dermatol. 2022;49(10):957-969. doi:10.1111/1346-8138.16508
8. Gehin JE, Goll GL, Brun MK, Jani M, Bolstad N, Syversen SW. Assessing immunogenicity of biologic drugs in inflammatory joint diseases: progress towards personalized medicine. BioDrugs. 2022;36(6):731-748. doi:10.1007/s40259-022-00559-1
9. Mysler E, Azevedo VF, Danese S, et al. Biosimilar-to-biosimilar switching: what is the rationale and current experience? Drugs. 2021;81(16):1859-1879. doi:10.1007/s40265-021-01610-1
10. Pascoe VL, Enamandram M, Corey KC, et al. Using the Physician Global Assessment in a clinical setting to measure and track patient outcomes. JAMA Dermatology. 2015;151(4):375-381. doi:10.1001/jamadermatol.2014.3513
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