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New Emirates Medical Journal

Volume 3, 2 Issues, 2022
ISSN: 0250-6882 (Online)
This journal supports open access

Open Access Article

Systemic Treatments for Adult Patients with Moderate-to-Severe Psoriasis: Consensus Statements for the United Arab Emirates



Anwar Al Hammadi1, *, Muna Al Murrawi2, Huda R. Ali3, Ashraf M. Reda4, Hussein A. Dayem5, Jawaher Alnaqbi6, Zaidoon Abdelhadi7, Samir Hantirah8, Ayman Alnaeem9, Fatima Al. Marzooqi10, Amani Alfalasi11, Fatima Albreiki12, Khadija Aljefri1, Faiza Al Ali13
1 DermaMed Clinic, Dubai, UAE
2 Dr. Muna Al murrawi Medical Center, Abu Dhabi, UAE
3 SEHA – Ambulatory Healthcare Services, Al Maqtaa Healthcare Center, Abu Dhabi, UAE
4 Mediclinic Welcare Hospital, Dubai, UAE
5 Mediclinic Al Noor Hospital, Abu Dhabi, UAE
6 Fujairah Hospital, Ministry of Health and Prevention, Fujairah, UAE
7 Sheikh Khalifa Medical City, Abu Dhabi, UAE
8 American Hospital, Dubai, UAE
9 Ibrahim Bin Hamad Obaidullah Hospital, Emirates Health Services Establishment, Ras al Khaimah, UAE
10 Zayed Military Hospital, Abu Dhabi, UAE
11 Rashid Hospital, Dubai Health Authority, Dubai, UAE
12 Tawam Hospital, Abu Dhabi, UAE
13 Al-Qassimi Hospital, Ministry of Health and Prevention, Sharjah, UAE

Abstract

Background:

Psoriasis is a chronic, immune-mediated disease characterized by mild localized plaques to severe plaques involving any part of the skin; it has a pronounced effect on patients’ quality of life. In the United Arab Emirates (UAE), there are limited local guidelines for the management of patients with psoriasis in daily clinical practice.

Objectives:

The study aimed to develop consensus statements for the evaluation and management of moderate-to-severe psoriasis in the UAE.

Methods:

To develop consensus statements, the Emirates Dermatology Society set up advisory board meetings in which local key opinion leaders (KOLs), including dermatologists from the UAE, participated. A targeted literature review was conducted to review current international and regional guidelines on the management of psoriasis, based on which the statements were formulated. A final consensus on each statement was reached based on collective agreement among the KOLs.

Results:

Consensus statements were generated with the intention of supporting physicians in clinical decision-making with respect to the classification of disease severity, treatment options including biologic and non-biologic systemic therapies, transitioning and adjusting of systemic therapies, and monitoring and management of psoriasis in special populations.

Conclusion:

These consensus statements could provide useful, practical guidance on the diagnosis and management of patients with moderate-to-severe psoriasis and would cater to the needs of physicians in the UAE.

Keywords: Psoriasis, Consensus statement, Dermatology, Medication therapy management, Non-biologic therapy, Biologic therapy.


Article Information


Identifiers and Pagination:

Year: 2022
Volume: 3
Issue: 1
First Page: 17
Last Page: 34
Publisher Id: nemj-3-17
DOI: 10.2174/02666211213145047

Article History:

Received Date: 02/08/2021
Revision Received Date: 25/10/2021
Acceptance Date: 31/10/2021
Electronic publication date: 21/01/2022
Collection year: 2022

© 2022 Al Hammadi et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


* Address correspondence to this author at the DermaMed Clinic, Dubai, UAE; Tel: +971 4 385 2222; E-mail: skinest@hotmail.com




1. INTRODUCTION

Psoriasis is a chronic, immune-mediated disease affecting 2–3% of the global population. It is characterized by mild localized plaques to severe plaques involving any part of the skin [1, 2]. These manifestations greatly affect patients’ quality of life (QoL). Based on these factors, patients with psoriasis are frequently classified into the mild, moderate, or severe category, depending on the clinical severity of the lesions, the percentage of affected body surface area (BSA), and QoL. As a disease of systemic inflammation, psoriasis is associated with multiple comorbidities, including arthritis, cardiovascular disease, diabetes, and malignancy.

Although psoriasis is incurable, there are multiple effective treatment options for its management, including topical agents, phototherapy, conventional systemic (non-biologics), and biologic therapy. The choice of therapy is mainly determined by disease severity and comorbidities. Most patients with mild-to-moderate psoriasis are able to effectively control the disease solely with topical agents or phototherapy alone or with a combination of both. However, these treatments might be insufficient in patients with moderate-to-severe disease. Hence, systemic therapies are generally prescribed to such patients, including immunosuppressive or immunomodulatory drugs such as methotrexate (MTX), ciclosporin (CSA), apremilast, and biologic agents, as well as systemic retinoids such as acitretin. Biologic agents, as monotherapy or combined with other topical or systemic medications, are also quite effective in the management of moderate-to-severe psoriasis. Most global psoriasis guidelines, including those from the American Academy of Dermatology, British Association of Dermatologists, the National Institute for Health and Care Excellence (NICE), and European S3-Guidelines, recommend biologic agents when one or more conventional systemic agents are either not tolerated or deemed unsuitable due to the presence of other comorbidities [3-5].

Despite the availability of sufficient information on the management of psoriasis from evidence-based treatment guidelines [3, 5, 6], there are major unmet needs in daily clinical practice, particularly in the Middle East region, including regarding treatment- and safety-related issues faced by patients and inconsistencies among physicians in clinical practice [7]. Patients often report that they do not receive optimal care to reduce their skin symptoms and are frequently left on treatments for prolonged periods, even though they are ineffective [7-9]. Furthermore, from the perspective of physicians, there is no consistency in clinical practice when it comes to the diagnosis and management of psoriasis [10]. In the United Arab Emirates (UAE), there are limited local guidelines for evaluating and managing patients with psoriasis in routine clinical practice. Hence, it is necessary to develop clear, definitive strategies for the management of psoriasis that cater to the needs of physicians in the region.

The aim of the advisory board meeting was to develop consensus statements for the evaluation and management of moderate-to-severe psoriasis in the UAE.

2. METHODS

To develop consensus statements, the Emirates Dermatology Society set up two advisory board meetings. Local key opinion leaders (KOLs), including dermatologists from the UAE, were recruited to participate in these meetings. The main objective was to facilitate the selected KOLs to deep dive into the available international and local guidelines to identify gaps to be bridged, incorporate new scientific data, highlight unmet needs in current clinical practice, and agree on consensus statements for the UAE.

2.1. Targeted Literature Review

An extensive literature search was conducted to review current international and local guidelines, and treatment paradigms and gaps were assessed in local treatment algorithms for the UAE. Guidelines that were part of the literature review included regional guidelines, which were compared with the latest international guidelines (American Academy of Dermatology (AAD)—Management and Treatment of Psoriasis with Biologics Clinical Practice Guidelines, British Association of Dermatologists Guidelines for Biologic Therapy for Psoriasis, NICE—Psoriasis: Assessment and Management, European S3-Guidelines) on the systemic treatment of psoriasis vulgaris and Saudi Practical Guidelines on Biologic Treatment of Psoriasis [3-6, 11, 12].

Based on the review of international and regional guidelines for the management of psoriasis, consensus statements were formed and grouped into the following categories: classification of disease severity; treatment options, including biologic and non-biologic systemic therapies; efficacy and safety profiles of systemic therapies; monitoring and management of psoriasis in special populations. Finally, key findings from the review were presented to the advisory board as statements.

2.2. Voting Procedure

A total of eight KOLs participated in the first advisory board meeting. Live voting was conducted, in which each participant had to vote either in favor of (Yes) or against (No) each statement. The consensus was established based on the collective agreement of the advisory board members for each statement. Members also had the option to modify or form additional statements based on their experience and local clinical practice. After the voting was completed, consensus statements were generated. These statements were further validated at the second advisory board meeting, in which 14 KOLs participated. The final consensus statements were then approved by all the members of the advisory board.

3. RESULTS AND DISCUSSION

3.1. Classification of Disease Severity

Presently, there is inconsistency in categorizing psoriasis based on severity, as no standard definition has been accepted [13]. Based on observations from clinical practice, the experts agreed to classify patients with psoriasis into three categories according to the severity of disease, i.e.., mild, moderate, and severe psoriasis. This classification is in accordance with the different metrics of screening tools used for measuring the severity of psoriasis, among which the Psoriasis Area and Severity Index (PASI), BSA, and the Dermatology Life Quality Index (DLQI) scores are the most widely accepted tools.

The BSA represents the percentage of psoriatic lesions on the body surface through the “rule of nines,” which is defined as 9% coverage for the head and neck, arm, anterior and posterior legs, and each of 4 trunk quadrants, and only 1% for the genitalia. It can also be estimated by counting the number of hands that would represent the percentage affected [14]. The PASI is a validated quantitative rating score for measuring the severity of psoriatic lesions depending on the area covered and the appearance of plaques [15]. The PASI combines the assessment of the severity of lesions and the percentage of area affected into a single score ranging from 0 (no disease) to 72 (maximal disease severity) [16]. The DLQI score has also become an essential tool to evaluate the impact of psoriasis on health-related QoL. Several studies have concluded that DLQI has a reliable grading system and is easy to use [17, 18]. The DLQI uses a scoring range from 0 to 30 and is graded as follows: 0–1=“no effect”; 2–5=“small effect”; 6–10=“moderate effect”; 11–20=“very large effect”; 21–30=“extremely large effect”.

Most decisions related to the management of psoriasis are taken with respect to disease severity and its clinical implications. A combination of different scores, i.e.., BSA, PASI, and DLQI, is used to assess the severity of the disease. However, the experts suggested that patients should be classified as moderate-to-severe if the score of at least one of the severity assessment tools is more than 10. Furthermore, the experts mentioned that BSA and PASI should be assessed by physicians/specialists, while the DLQI report must be generated through a questionnaire designed for patients.

In addition, disease manifestations that may significantly affect patients’ QoL should also be considered. These include major involvement of the scalp, genitals, visible areas such as the face and palms, onycholysis or onychodystrophy of at least two fingernails, pruritus, and the presence of recalcitrant plaques [4, 5, 11, 12].

Consensus statements on the classification of disease severity are presented in Table 1.

3.2. Treatment Options

For patients with mild psoriasis, topical therapy (including corticosteroids, vitamin D3 analogs in combination with corticosteroids) and calcineurin inhibitors are given as the first-line of treatment. For patients with plaque or guttate-pattern psoriasis that cannot be controlled with topical treatments alone, combination therapy with topical therapy and phototherapy, which includes narrowband ultraviolet B (UVB) and excimer laser (wavelength of 308 nm), should be considered. Patients with moderate-to-severe psoriasis may also benefit from phototherapy. An excimer laser is used to treat small areas of the body or difficult-to-treat sites [19].

Systemic therapies are most commonly used for the treatment of patients with moderate-to-severe psoriasis and include conventional non-biologic systemic therapies, as well as biologic therapy, which will be discussed in more detail in forthcoming sections (Fig. 1).

3.2.1. Non-biologic Systemic Therapy

In the UAE, the most commonly used non-biologic systemic therapies include MTX, CSA, apremilast, and acitretin. According to the experts, the criteria for choosing a therapy should be individualized based on the patient profile, medical history, disease severity, and comorbidities.

There was unanimous agreement on the use of non-biologic systemic therapy, and the suggested recommendations on the indications and dosages of each therapy conform with the product label (Table 2).

Fig. (1)
Treatment pathway for psoriasis*.
UVB: Ultraviolet B; TNF: Tumor necrosis factor; IL: Interleukin.
*According to expert consensus.
Note: The treatments listed under different therapies do not depict any particular order of preference. All treatments are listed in alphabetical order.

Table 1
Consensus statements on the classification of disease severity.

Table 2
Consensus statements on non-biologic systemic therapies.

In terms of efficacy and safety profiles, the experts agreed that clinicians should adhere to the prescription label and follow local guidelines if any. MTX has been shown to be effective in psoriasis and is associated with successful treatment response, as defined by an improvement in the PASI score by 50% to 75% and in absolute DLQI value [20-22]. However, MTX is associated with risk factors, including liver disease, obesity, alcohol intake, and type 2 diabetes, and is also contraindicated in pregnancy due to its teratogenic, abortifacient, and mutagenic effects [23-28]. The use of CSA has shown promising results in achieving treatment response as a short-term therapy; however, there is a significant risk of renal toxicity, arterial hypertension, and non-melanoma skin cancer [29-31]. Acitretin is generally considered for palmoplantar or pustular forms of psoriasis and is prescribed at either low doses for better tolerability or high doses for better efficacy [4]. In terms of safety, acitretin is classified by the Food and Drug Administration (FDA) as a class X drug due to its teratogenic effects and is contraindicated in pregnancy [27, 28]. Recent randomized controlled trials of apremilast have indicated that around 33.1% of patients show PASI 75 response by Week 16; apremilast was found to be effective in palmoplantar, scalp psoriasis, and nail psoriasis [32-34]. Its common side effects include nausea, diarrhea, and upper respiratory tract infections that resolve over time; however, it should be discontinued if patients suffer from any psychiatric symptoms or if suicidal ideation or suicidal behavior is identified [4].

Overall consensus statements on the management of moderate-to-severe psoriasis using non-biologic systemic therapies are presented in Table 2 [35-45].

3.2.2. Biologic Systemic Therapy

In the UAE, the most commonly used biologic systemic therapies include tumor necrosis factor (TNF) inhibitors (adalimumab, certolizumab pegol, etanercept, infliximab), interleukin (IL)-12/23 inhibitors (ustekinumab), IL-17 (brodalumab, ixekizumab, and secukinumab), and recently approved IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab). According to the experts, biologics can be prescribed early in the treatment paradigm as the first-line treatment on a case-by-case basis, depending on the severity of disease, presence of comorbidities, and location of lesions (Table 3).

The panel has also suggested that the criteria for choosing biologic therapy should be individualized based on the patient profile and medical history, and other factors-including the availability of drugs and treatment costs.

There was unanimous agreement among the experts on the indications and dosage of different biologic therapies. This was in line with the product labels, as well as international guidelines, which specified that biologic agents are routinely used in case of failure of non-biologic therapy due to inadequate response, safety concerns, or the presence of comorbidities. The experts also reached a consensus on the use of biologics based on disease location and subtypes in patients with moderate-to-severe psoriasis [3].

The TNF-α inhibitors are considered first-generation biologics. Evidence on the positive efficacy of anti-TNF therapies for plaque psoriasis is well established. Different PASI 75 response rates have been reported in clinical studies in the context of treatment for psoriasis with anti-TNF therapies of varying doses: 33% (50 mg weekly) and 49% (50 mg twice weekly) for etanercept at Week 12 [46], 71% for adalimumab at Week 16 [47, 48], 75.5% (5 mg/kg) and 70.3% (3 mg/kg) for infliximab at Week 10 [49], and 75% (200 mg every 2 weeks) and 83% (400 mg every 2 weeks) for certolizumab pegol [50]. Local injection-site reactions, infections, and autoimmune phenomena are common adverse events (AEs) associated with anti-TNF therapies. Ustekinumab, an IL-12/23 inhibitor, has been shown to have a PASI 75 response of 72.4% and 61.2% at 90 mg and 45 mg, respectively, at Week 76 [51-53]. Common AEs listed for ustekinumab include nasopharyngitis and upper respiratory tract infections. Several studies have also assessed the efficacy of IL-17 inhibitors, including secukinumab, in psoriasis with 81.6% and 28.6% of patients reaching PASI 75 and PASI 100 response at Week 12 [54]. Secukinumab showed a rapid onset of action and was found to be superior to ustekinumab [55, 56]. Both ixekizumab and brodalumab also showed a more promising response when compared to placebo with 89.1% and 83.3% PASI 75 response, respectively, at Week 12 [57, 58]. Frequent AEs of IL-17 inhibitors include nasopharyngitis, headache, upper respiratory tract infection, and arthralgia [54].

Of note, IL-23 inhibitors are the newest class of biologics approved for patients with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy or have failed response to other systemic therapies. They are being used by physicians in their local practice for the treatment of psoriasis in the UAE. IL-23 inhibitors have shown positive results in terms of efficacy. With risankizumab, PASI 75 and PASI 90 response was observed in 88% and 81% at Week 12 [59]. Guselkumab has been reported to be clinically more advantageous than adalimumab, with 85.1% of patients reaching PASI 75 response and 73.3% receiving PASI 90 response at Week 16 [60, 61]. Furthermore, results from the phase 3 ECLIPSE trial indicate that the proportion of patients with a PASI 90 response at Week 48 was greater for guselkumab in comparison to secukinumab (84% versus 70%) [62]. In the case of tildrakizumab, clinical studies showed 74% PASI 75 and 52% PASI 90 at Week 16, and patients on tildrakizumab were more likely to reach PASI 75 at Weeks 16 and 28 as compared to patients on etanercept [63, 64]. Safety studies also reported IL-23 inhibitors to be associated with upper respiratory infections, headache, fatigue, injection-site reactions, diarrhea, gastroenteritis, arthralgia, herpes simplex infections, and tinea infections.

3.2.3. Treatment Response

Attaining complete clearance of skin lesions and avoiding suboptimal or unnecessary treatment are the key goals in treating psoriasis. The expert panel agreed that therapeutic goals should be defined based on the criteria recommended in the recent French guidelines (2019) [65]:

  • Absolute PASI ≤3: Reflects clear or almost clear status (or a physician global assessment [PGA] score of 0–1) of the patient.
  • DLQI 0 or 1: Indicates the absence of impact of psoriasis on QoL.
  • PASI 90 and PASI 100 responses: This criterion has emerged because of the high efficacy of some of the most recent biological agents (Fig. 2).
Fig. (2)
Treatment response in plaque psoriasis based on PASI and DLQI scores.
DLQI: Dermatology Life Quality Index; PASI: Psoriasis Area Severity Index.
Source: Amatore F, Villani AP, Tauber M, Viguier M, Guillot B. French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. Journal of the European Academy of Dermatology and Venereology: JEADV. 2019;33(3):464-483. (Accessed May 07, 2020).

Table 3
Consensus statements on biologic systemic therapy.

3.2.4. Combination Therapy

Due to limited efficacy studies, there are no approved indications and doses for the combination of biologic therapy with conventional systemic therapy for the treatment of psoriasis. However, a literature review by Heffernan indicated the potential benefits of combination therapy, including additive or synergistic improvement in efficacy and minimized cost and toxicity, by using lower doses of the drug [66]. As such, most recent global guidelines recommend adding low-dose MTX or acitretin to anti-TNF therapy with the aim of improving efficacy, optimizing the risk/benefit profile, lowering the risk of immunogenicity (with MTX), and enhancing long-term disease management. Some trials have shown beneficial treatment effects using a combination of MTX and anti-TNF therapies [67, 68].

Conversely, potential complications exist when combining non-biologic systemic therapy and biologic therapy, including issues with drug metabolism and additive AEs [66]. There is a potential increased risk of nephrotoxicity, hypertension, and non-melanoma skin cancer with the combination of CSA and anti-TNF therapies or ustekinumab [69]. Further, there is a dearth of evidence on the use of MTX with IL-12/IL-23, IL-17, and IL-23 antagonists, although a combination of MTX with IL-12/IL-23 is suggested for psoriatic arthritis (PsA). According to the consensus report by Mrowietz et al., optimal safety monitoring for combination therapy has not been established and may involve parameters that require more frequent monitoring [70].

Consensus statements on the management of moderate-to-severe psoriasis using biologic systemic therapies are presented in Table 3.

3.2.5. Transitioning and Adjusting Therapy

Emphasis on dose escalation, switching or stopping of therapy, and resuming treatment after stopping in case there is an inadequate response were also considered by the experts. Dose escalation strategies for individual drugs are presented in Table 3.

The expert panel also agreed that switching to alternative therapy should be considered in case treatment response is not achieved even after the optimum dose and duration of treatment. Based on the reviewed international guidelines, strategies to transition from non-biologic systemic to biologic therapy and between different classes of biologic therapy were suggested [3, 5]. Although there is little evidence, stopping systemic therapy can be considered in patients with well-controlled psoriasis on a case-by-case basis [70].

In addition, the panel also agreed that restarting or resuming biologic treatment after discontinuation should be done on an individual basis, taking into account the severity of the disease and the number of doses missed [3].

Consensus statements for transitioning and adjusting therapy are shown in Table 4.

3.3. Monitoring

3.3.1. Non-biologic Systemic Therapy

Before starting any systemic therapy, there must be a practical approach in place to monitor patients on the basis of their medical history, physical examination, and laboratory tests in order to maximize the benefits and minimize the risks associated with these drugs. Based on the European S3-Guidelines and local practice, there was an agreement among the experts with regard to the appropriate laboratory tests required for monitoring of patients with moderate-to-severe psoriasis who are eligible for non-biologic systemic therapy [4, 6]. These include periodic blood count and liver function tests, along with screening for hepatotoxicity, renal toxicity, malignancies, and serious infections—including hepatitis and human immunodeficiency virus (HIV).

Screening and laboratory controls required for monitoring at baseline and during treatment in patients taking non-biologic systemic therapy are presented in Table 5. Overall consensus statements on monitoring requirements for non-biologic systemic therapy are presented in Table 6.

Table 4
Consensus statements on transitioning and adjusting therapy.

Table 5
Monitoring requirements for non-biologic systemic therapy.

Table 6
Consensus statements on monitoring requirements for non-biologic systemic therapy.

3.3.2. Biologic Systemic Therapy

Although several guidelines and reviews offer recommendations on screening and monitoring tests for biologics, there are no definitive recommendations, given widespread variations in prescriber practices, the prevalence rates of risks associated with therapy, availability of tests, etc. Based on the available guidelines, the experts agreed that prior to initiating biologic therapy, it is important to obtain a baseline evaluation of the patient, including hematology and biochemistry, screening for severe infections—including tuberculosis (TB), hepatitis B virus (HBV)/hepatitis C virus (HCV), and HIV, and case-by-case assessment for malignancy and inflammatory bowel disease (IBD) [3, 4, 6].

Screening and laboratory controls required for monitoring at baseline and during treatment in patients taking biologic systemic therapy are presented in Table 7. Consensus statements on monitoring requirements for biologic systemic therapy are presented in Table 8.

3.4. Special Populations

3.4.1. Pregnancy and Nursing Mothers

For pregnant women with milder forms of psoriasis, topical corticosteroids and UVB are considered the safest options for treatment. For those who require systemic therapy, CSA is a reasonable choice, although it is associated with an increased risk of hypertension [27], low birth weight, intrauterine growth retardation, and premature delivery. Acitretin and MTX are contraindicated in pregnancy due to their teratogenic effects [27, 28].

Table 7
Monitoring requirements for biologic systemic therapy.

Table 8
Consensus statements on monitoring requirements for biologic systemic therapy.

Biologics should be used with more caution in women of childbearing potential or those who become pregnant. In such patients, the benefits and risks of continuing versus stopping biologic treatment should also be discussed [5]. Studies have shown that any risks of biologic use, particularly with anti-TNF therapies and IL-12/23 inhibitors in pregnancy, are not related to teratogenesis and congenital malformations but to immunosuppression of the neonate [28, 71]. Moreover, it is likely that most immunoglobulins can be excreted in human milk, although data are limited. Hence, there is a potential for adverse reactions in nursing infants from mothers undergoing biologic therapy. However, certolizumab pegol has shown minimal to no placental transfer and is safer for use in breastfeeding women compared to other biologics [72]. In the case of IL-17 and IL-23 inhibitors, there are insufficient data on their use in pregnant and breastfeeding women to inform any drug-associated risk of adverse developmental outcomes. Thus, no recommendations on using IL-17 and IL-23 inhibitors were provided in any guideline for this population. The experts’ recommendations are, therefore, in line with current evidence and prescription labels, suggesting that both certolizumab pegol and adalimumab can be prescribed (with caution) during pregnancy and breastfeeding if the benefits outweigh the risks.

3.4.2. Geriatric Use

In elderly patients starting treatment with MTX, dose reduction should be considered due to reduced hepatic and renal function, as well as lower folate reserves, which occur more frequently with increased age [35]. Similarly, dose adjustment is also required in elderly patients being treated with CSA, along with regular monitoring of renal function during the course of treatment [40]. In the case of acitretin and apremilast, no dose adjustment is required for elderly patients [44, 45]. Anti-TNF therapies, on the other hand, are a safer option in elderly patients with moderate-to-severe disease, although side effects are more likely to occur with adalimumab [4]. In the case of IL-12/23, IL-17, and IL-23 inhibitors, safety or efficacy outcomes were consistent between older and younger subjects, and, hence, no dose adjustments are required [73-79].

3.4.3. Malignancies

Long-term use of certain psoriasis treatments such as PUVA, UVB irradiation, and CSA is associated with an increased risk of developing non-melanoma skin cancer and lymphomas [31, 80, 81]. Patients with psoriasis taking CSA should avoid concomitant UVB or PUVA photochemotherapy and should be monitored for non-melanoma skin cancers (NMSC) prior to and during treatment [40].

In the case of biologics, studies have suggested that there is no risk of solid tumor or lymphoreticular malignancy when using anti-TNF therapies and IL-12/23 inhibitors as monotherapy in patients with moderate-to-severe psoriasis [82, 83]. Likewise, both anti-TNF therapies and IL-12/23 inhibitors can be prescribed to patients with a history of solid tumor malignancy who have failed ultraviolet phototherapy, MTX, and/or acitretin without expecting any risk of tumor recurrence [84, 85]. However, caution should be exercised in such patients if cancer has been diagnosed and treated less than five years previously and/or where the baseline risk of skin cancer (such as in patients previously treated for NMSC) is increased [4, 5]. Additionally, there is no conclusive evidence that other biologics, such as IL-17 and IL-23, have any associated risk of malignancy, as more long-term safety studies are required to evaluate their safety profiles. However, findings from clinical studies show that the incidence of malignant or unspecified tumors in patients receiving secukinumab was consistent with expected rates for patients with psoriasis [86]. Considering the available data, the experts agreed that biologics could be considered in the treatment paradigm, given that their benefits outweigh the negligible risk of solid organ malignancy.

3.4.4. Tuberculosis (TB)

Biologics, especially anti-TNF therapies, are associated with an increased risk of activating latent tuberculosis infection, leading to severe morbidity and mortality in some cases [87, 88]. However, in the case of IL-12/23 inhibitors, the occurrence of tuberculosis has been rarely observed [89]. Similarly, the risk of TB reactivation is relatively lower in patients taking IL-17 and IL-23 inhibitors as compared to patients taking anti-TNF therapies [86, 90]. However, as most biologics are immunosuppressive, it is important that all patients are screened for latent TB using purified protein derivative (PPD) skin test or QuantiFERON-TB Gold prior to initiating treatment. If active TB is suspected, treatment with biologics should be deferred, and patients should be treated with rifampicin, isoniazid, pyrazinamide, or ethambutol [91]. In case latent tuberculosis is detected, patients should begin prophylaxis for TB with rifamycin-based treatment regimens or isoniazid [92]. When anti-tuberculous therapy is indicated, patients should aim to complete one month of treatment before initiating any biologic therapy [12].

3.4.5. Hepatitis Virus Reactivation

MTX is relatively contraindicated in patients with active or recurrent HBV, considering MTX is significantly associated with hepatotoxicity [93, 94]. Similarly, the occurrence of hepatitis has also been reported in patients taking acitretin. Hence, prior to initiating therapy with acitretin, it is necessary that patients undergo liver function tests [44]. For active HBV, the experts agreed that patients with psoriasis should not be prescribed immunosuppressive therapies till it is controlled by antiviral treatment [3, 4]. Consecutively, reactivation of HBV can occur due to a compromised immune system as a result of using biologics in patients identified as carriers of HBV or in those who were previously infected with the virus [95]. Such patients may require antiviral prophylaxis 2-4 weeks before starting immunosuppressive therapy [95]. It is also necessary that these patients are monitored periodically for any clinical signs and symptoms of active infection and undergo liver function tests prior to and during treatment with biologics for psoriasis [96]. In the case of HCV, patients with a history of or currently active infection may receive biologics for the management of psoriasis [96-98]. The occurrence of HCV reactivation with regard to the administration of biologics is rare. However, periodic monitoring of patients through measuring HCV RNA load, as well as standard liver function tests, is required in order to exclude the likelihood of such events.

Overall, although HBV or HCV infection is not considered a barrier to the administration of immunosuppressive therapy in patients with moderate-to-severe psoriasis, it is important to take necessary precautions due to the risk of reactivation in patients with a history and/or those who are inactive carriers of the virus. Therefore, the experts agreed that there must be a multidisciplinary approach involving gastroenterologists/hepatologists for the treatment of hepatitis virus among patients with psoriasis [3-5].

3.4.6. Infections

The infection risk in psoriasis patients taking biologics therapy does not seem to be higher during the first year of use; however, the occurrence of serious infections is still plausible [99]. As per product labels, the use of anti-TNF therapy can lead to serious infections, such as histoplasmosis, bacterial sepsis, and infections caused by other opportunistic pathogens [72, 100-102]. Serious infections associated with IL-12/23 inhibitor include pneumonia, appendicitis, cellulitis, cholecystitis, diverticulitis, osteomyelitis, sepsis, gastroenteritis, viral and urinary tract infections [73]. Similarly, for patients taking IL-17 inhibitors, there is an increased risk of nasopharyngitis, upper respiratory tract infection, and arthralgia; Candida infections occur more frequently with secukinumab and ixekizumab [74-76]. Clinical studies for IL-23 inhibitors reported diarrhea, gastroenteritis, arthralgia, upper respiratory infections, tinea infections, and herpes simplex infections as the most common infections [77-79]. Overall, the risk of serious infection varies across treatments, although there is a higher risk of serious infections with anti-TNF therapies as compared to IL-23 and IL-17 inhibitors [86, 103, 104]. Based on recommendations from international guidelines, the experts agreed that in order to manage the risk of serious infections in patients on biologics, regular monitoring of early signs and symptoms of infection should be done prior to and during treatment in high-risk patients [105].

Overall consensus statements on the management of psoriasis in special populations are presented in Table 9.

Table 9
Consensus statements on special populations.

3.4.7. COVID-19

Coronavirus disease (COVID-19) is a highly contagious respiratory infection that has become a serious public health concern. At present, there are no conclusive data to determine its impact on patients with psoriasis receiving systemic treatment. However, several international guidelines have come up with recommendations on the management of psoriasis during the pandemic. For patients with psoriasis diagnosed with COVID-19, the National Psoriasis Foundation recommends that the decision to start or stop a biologic or oral systemic therapy should be made on a case-by-case basis, in consultation with the health care provider [109]. In addition, the International Psoriasis Council (IPC) recommends that physicians should either discontinue or delay the use of immunosuppressant medications [110]. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and NICE have also advised patients to temporarily stop their medications if they are COVID-19 positive and to follow the advice of the doctor on temporarily stopping, reducing, or delaying taking medications in specific circumstances [111, 112]. Furthermore, the British Association of Dermatologists guidelines offer a grid for health care professionals that can aid in identifying patients who are at a higher risk of COVID-19 due to their disease and treatment [113].

Recent evidence suggests that older patients (>60 years) and/or patients with certain underlying health conditions, including chronic obstructive pulmonary disease, diabetes, cardiovascular diseases, chronic kidney diseases, and cancer, are more likely to develop severe illness. Therefore, the guidelines also recommend considering the risks and benefits of any immunosuppressive therapy in patients with comorbidities on a case-by-case basis [109, 110, 112].

According to the IPC, and as of September 2020, it is still uncertain whether psoriasis is a risk factor for COVID-19 or whether it may lead to poor outcomes associated with COVID-19. Comorbidities associated with psoriasis have been found to be important risk factors (especially obesity) for adverse COVID-19 outcomes. Moreover, as vaccines are being developed and population vaccination schedules are already planned, it is important to consider the impact of psoriasis treatments-particularly systemic therapy-on the effectiveness and safety of these vaccines [110].

CONCLUSION

The experts’ recommendations are based on local practice and their experience, particularly in areas where evidence is lacking. These consensus statements will enable psoriasis experts to provide useful and practical advice on the diagnosis and management of patients with moderate-to-severe psoriasis in the UAE. Further clinical investigations are needed to enhance these expert-based recommendations.

CONSENT FOR PUBLICATION

Not applicable.

FUNDING

This work was funded by Janssen Pharmaceuticals.

CONFLICT OF INTEREST

The authors declare no conflict of interest, financial or otherwise.

ACKNOWLEDGEMENTS

The authors would like to thank IQVIA for their participation and contribution in the advisory board meetings and its medical writers for providing writing support. This work was financially supported by Janssen. The authors are fully responsible for all content and editorial decisions; they were involved at all stages of manuscript development and have approved the final version.

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Editor-in-Chief

Abdullah Shehab
Emirates Cardiac Society
Emirates Medical Association
Dubai
(United Arab Emirates)
Biography
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