The only exception to this protocol is in psoriatic arthritis studies where methotrexate and systemic steroids at stable doses are used in up to 50 of cases. Combinations of potent topical corticosteroids (table 1) and either calcipotriene, calcitriol, tazarotene, or UVB phototherapy are commonly prescribed by dermatologists. Patients with less acute disease can be treated with acitretin or methotrexate as first-line agents. Many agents used in the treatment of adult psoriasis have also been used for children 16. Combining Biologic Therapies With Other Systemic Treatments in Psoriasis: Evidence-Based, Best-Practice Recommendations From the Medical Board of the National Psoriasis Foundation. Combining biologics, such as etanercept or adalimumab, with phototherapy likely results in greater reduction in disease severity than either alone.
Psoriasis has been associated with a significant negative impact on the patient’s quality of life, due to the disfiguring effect of the skin lesions and, for some, the functional impairment resulting from joint pain 3. Additionally, data from clinical trials evaluating adalimumab in rheumatoid arthritis demonstrate that patients on methotrexate had significantly higher blood levels of adalimumab than patients treated with adalimumab alone 30. Among the most successful strategies for treatment has been the use of biologic immunotherapies targeting tumor necrosis factor alpha (TNF). Recent research has evaluated the efficacy and safety of a new anti-TNF agent, adalimumab. One of the central immunological mediators in psoriasis is the cytokine TNF-. Furthermore, although this study used a published protocol for methotrexate dosing, it has been argued that the methotrexate response would be higher with a more aggressive treatment regimen. Our understanding of the pathogenesis of psoriasis has developed at a remarkable rate in recent years. Randomized, double-blind controlled trials have shown significant benefit from combined therapy preparations with one study reporting 92 achieving control over 52 weeks. 27 Despite this, it is only recently that delivery of narrow band UVB has been possible on a widespread basis. III Comparative Study of Adalimumab versus Methotrexate versus Placebo in Psoriasis Patients (CHAMPION) study, have revealed similar levels of efficacy.
Prospective, randomised clinical trials evaluating the efficacy of combination therapy versus monotherapy would provide much-needed clarity on treatment options for patients with PsA. Its use has been studied extensively for its safety and efficacy profile in the clinical setting. The REVEAL (Randomized Controlled Evaluation of Adalimumab) study (Table 1) was a Phase III randomized controlled evaluation of adalimumab every other week dosing in moderate to severe psoriasis. Table 1 A comparison of three Phase III clinical trials on the use of adalimumab for treating chronic plaque psoriasisNotes: aREVEAL12, Randomized Controlled Evaluation of Adalimumab every-other-week dosing in moderate to severe psoriasis trial; bCHAMPION16, Comparative study of Humira vs Methotrexate vs Placebo in Psoriasis patients; Published online: 16 Mar 2015. MTX in combination with biologics, especially infliximab and adalimumab.
Use Of Biologic Agents In Combination With Other Therapies For The Treatment Of Psoriasis
Aetna considers biological therapies adalimumab (Humira), apremilast (Otezla), etanercept (Enbrel), infliximab (Remicade), secukinumab (Cosentyx), and ustekinumab (Stelara) medically necessary for adults aged 18 years and older with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy when the following selection criteria are met:. In addition, small studies have been published with successful therapeutic intervention using alefacept, visilizumab or anakinra, but controlled trials are needed. The authors concluded that these findings demonstrated the need for additional long-term trials with standardized outcome measures to evaluate the efficacy and adverse effects of combination therapies for psoriasis and highlighted the possible effects of trial design characteristics on results. Methotrexate Injection official prescribing information for healthcare professionals. Methotrexate has been reported to cause fetal death and/or congenital anomalies. During therapy of rheumatoid arthritis and psoriasis, monitoring of these parameters is recommended: hematology at least monthly, renal function and liver function every 1 to 2 months. Published clinical studies evaluating the use of methotrexate in children and adolescents (i. Although a similar effect to methotrexate has been observed with AZA usage in the management of Crohn’s disease, there is insufficient evidence to suggest that other DMARDs impact immunogenicity. An important question is whether MTX should be prescribed in combination with biologic therapy in patients with AS, where DMARDs are not routinely prescribed for axial disease, and in psoriasis, where MTX is often discontinued before commencing biologic therapy. 1). Most studies to date, however, have either failed to detect ADAbs to etanercept or have detected them at lower levels compared with monoclonals, the highest level detected being 18 in psoriasis at 12 weeks 42. Published on behalf of. Where recommendations have been made for the use of drugs outside their licensed indications (‘off-label use’), these drugs are marked with a footnote in the recommendations. The most effective treatments have been characterized by underutilization, inconvenience, and adverse events, making long-term management challenging. Table 2 Structure and mechanism of action of biologics for chronic plaque psoriasis Clinical studies: Various clinical trials have evaluated the use of alefacept in patients with chronic plaque psoriasis.20-22 Patients included in these trials had chronic plaque psoriasis for more than 1 year before receiving alefacept. The clinical introduction of tumour necrosis factor (TNF) inhibitors has deeply changed the treatment of inflammatory bowel diseases (IBD). 1). Injection site reaction based on an allergic mechanism may later present as systemic allergic reaction when treatment is continued.
Comparative Effectiveness Of Biologic Monotherapy Versus Combination Therapy For Patients With Psoriatic Arthritis: Results From The Corrona Registry
Combined methotrexate ultraviolet B therapy in the treatment of psoriasis. Nonbiologic systemic therapies may be effective but can be associated with significant short-term and long-term adverse events (hepatotoxicity, nephrotoxicity, hypertension, dyslipidemia, malignancy, and teratogenicity). To date, no comparative effectiveness review comparing the effectiveness and safety of biologic systemic with nonbiologic systemic treatment options or phototherapy for chronic plaque psoriasis has been completed. To date, no comparative effectiveness review comparing the effectiveness and safety of biologic systemic with nonbiologic systemic treatment options or phototherapy for chronic plaque psoriasis has been completed. Only studies that evaluated interventions and comparators with an indication approved by the FDA at the time of writing this report were included in this CER. 2008;22:341-344. To evaluate the effectiveness and safety of adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to prior therapy. Subsequently, TNF has been validated as a therapeutic target in PsA and several other immune-mediated inflammatory diseases6. The ACCLAIM trial (A Canadian Open-Label Study to Evaluate the Safety and EffeCtiveness of AdaLimumab When Added to Inadequate Therapy for the TreatMent of Psoriatic Arthritis) was an open-label multicenter Phase IIIb study conducted in Canada in care settings that reflected usual practice. 1 of which had to have been methotrexate unless contraindicated).