Introduction
Biologics used to treat moderate-to-severe plaque psoriasis may cause injection site reactions (ISRs) characterized by erythema, edema, itch, and sometimes pain. The Federal Adverse ...Event Reporting System (FAERS) is a repository of spontaneous post-marketing reports of adverse events (AEs) that are reported to the US Food and Drug Administration (FDA). Our objective was to perform a pharmacovigilance analysis of FAERS reports of ISRs associated with the use of subcutaneously administered biologic products approved to treat moderate-to-severe plaque psoriasis.
Methods
The products included in our assessment were adalimumab, etanercept, ixekizumab, secukinumab, and ustekinumab. Reports from the date of US approval for each biologic as treatment for plaque psoriasis through 2 years were included using the search term “injection site.”
Results
The results show that the FAERS database contained reports of ISRs for all of the included biologics during the 2 years following FDA approval. The most common reports on ISRs were on pain, irritation, and erythema for adalimumab; reaction, pain, and erythema for etanercept; erythema, pain, and reaction for ixekizumab; bruising, pain, hemorrhage for secukinumab; and pain, induration, and swelling for ustekinumab. FAERS does not include data on total patient exposure; therefore, ISR rates could not be calculated.
Conclusions
Specific ISRs varied among the biologic therapies assessed. The findings presented could be helpful when patients consider switching therapies due to ISRs.
Funding
Eli Lilly and Company.
Background: Tildrakizumab is a high-affinity, humanized, IgG1 κ, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis.
Objectives: This analysis examined whether ...tildrakizumab's week-28 efficacy can be sustained or improved to week 52.
Methods: Psoriasis patients on the same-dose tildrakizumab (100 or 200 mg) in the first 52 weeks achieving week-28 PASI ≥50 were pooled from two phase-3 randomized controlled trials, and grouped into four mutually exclusive week-28 PASI response groups. Patients' week-52 PASI responses were compared to their week-28 PASI responses.
Results: Of 352 patients receiving 100-mg tildrakizumab, 10.5%, 25.3%, 38.4%, and 25.9% achieved PASI 50-74, 75-89, 90-99, and 100 at week 28, respectively. Among patients achieving PASI ≥90, ≥75, or ≥50 at week 28, 89.4%, 91.1%, or 97.4% maintained their week-28 PASI responses at week 52, respectively. Among patients achieving PASI 50-74, 75-89, or 90-99 at week 28, 64.8%, 33.7%, or 25.2% improved their week-28 PASI responses at week 52, respectively.
Limitations: This post hoc analysis may be less robust than an a priori analysis.
Conclusions: Most tildrakizumab-treated patients with week-28 PASI ≥75 maintained their week-28 PASI improvement at week 52. More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52.
Clinicaltrials.gov identifiers: NCT01722331, NCT01729754.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Psoriasis is a chronic inflammatory skin condition with a significant global burden of disease and a wide array of potential treatment options, ranging from topical to systemic therapies. There are ...currently 11 biologic agents approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe psoriasis. The emergence of IL-17 and IL-23 inhibitors has significantly improved the efficacy and safety of treatment options for patients with psoriasis. Given the number of potential therapies, a variety of factors may be considered in optimising a patient’s regimen, including efficacy, safety, cost, persistence rate, and discontinuation rate. The aim of this narrative review is to provide a concise yet comprehensive review of the biologic agents that inhibit IL-17 or IL-23 available for patients 18 years of age or older with moderate-to-severe psoriasis.
Over the past several years, an increased understanding of the pathophysiology of psoriasis and psoriatic arthritis (PsA) has led to the development of several new biologic therapies. Appropriate ...treatment selection and timing may slow, and even halt, the progression of psoriasis and PsA; as a result, it can decrease the economic burden. As treatment options vary based on individual disease characteristics and patient preferences, reviewing the patient's complete clinical picture is imperative. An updated treatment algorithm, based on patients' most severe disease domain, is now available to guide the selection of optimal therapy. Special care should be given to patients with both psoriasis and PsA who experience multiple disease domains, a heavy symptom burden, and an increased risk of comorbidities.
Background Novel therapies are needed for difficult-to-treat populations of patients with psoriasis. Objective We sought to assess the efficacy and safety of the interleukin-17 Receptor A inhibitor ...brodalumab in patients with psoriasis with or without a self-reported history of psoriatic arthritis (PsA) and with or without a history of biologic use. Methods Subset analyses of a phase II, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis were performed. Improvement from baseline in Psoriasis Area and Severity Index score of 75%, 90%, and 100% at week 12; static Physician Global Assessment (0/1) score; Dermatology Life Quality Index response; and Psoriasis Symptom Inventory response were evaluated within subgroups. Results Efficacy and quality-of-life measures were generally similar between subgroups of patients with or without a history of PsA and with or without a history of biologic use across brodalumab doses and were significantly higher among patients who received brodalumab 140 mg every 2 weeks or 210 mg every 2 weeks versus placebo. Limitations Differences between subgroups were not compared statistically, PsA was self-reported, only skin involvement/symptoms were reported, and reasons for discontinuation of prior biologic were not captured. Conclusion Brodalumab is efficacious in patients with psoriasis with or without a history of PsA or biologic use.
While biologic therapies for psoriasis are effective for many patients, some patients may lose response, have inadequate control of disease, or develop intolerance to certain biologic agents. It may ...therefore be beneficial for patients whose psoriasis fails to respond to one biologic to switch to a different biologic therapy, in particular one with a different mechanism of action. However, it remains unclear how prior biologic exposure or lack of response affects the efficacy and safety of subsequent biologics in patients with moderate-to-severe psoriasis. Brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, has previously been shown to be efficacious in treating moderate-to-severe psoriasis in three large phase 3 trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3). In this review, we summarize the efficacy and safety of brodalumab in patients with moderate-to-severe psoriasis and a history of biologic exposure. Further, we describe improvements in skin clearance and quality of life measures as well as safety in patients who had inadequate response to ustekinumab and who were rescued with brodalumab therapy. Lastly, we discuss improvements in skin clearance following rescue with brodalumab in patients whose disease failed to respond to secukinumab and ixekizumab. The findings of our review suggest that brodalumab is a safe and efficacious treatment regardless of past biologic use or lack of response to prior biologic therapy.
We report the first case of atopic dermatitis successfully treated with the oral Janus kinase-1 (JAK1) inhibitor oclacitinib. A man in his 70s, with a 6-year history of skin disease refractory to ...topical and biologic therapies, self-prescribed this veterinary medication with rapid remission of symptoms. He has remained in remission for 7 months with no reported adverse side effects or infections. JAK1 plays a central role in expression of proinflammatory cytokines IL-4, IL-5, and IL-13, which play an important role in the pathogenesis of atopic dermatitis. Ruxolitinib and tofacitinib are JAK inhibitors currently approved by the Food and Drug Administration for the treatment of myelofibrosis, rheumatoid arthritis, and psoriatic arthritis in humans. Oclacitinib is not currently indicated for use in humans.
Psoriasis (PsO) is a common, systemic, chronic, inflammatory disease characterized by key clinical symptoms, including itching, pain, and scaling. PsO is associated with a high prevalence of ...comorbidities, including other autoimmune diseases and malignancies. Furthermore, special populations, such as pregnant, pediatric, and elderly patients, and those with erythrodermic PsO, are challenging to treat and require tightly monitored disease and treatment management. Because certain populations have demographic or clinical characteristics that can affect the presentation of PsO and complicate treatment responses, these patient populations are largely excluded from clinical trials; therefore, most clinical evidence for the treatment of these patients is derived from case reports and series. Secukinumab, a fully human monoclonal interleukin-17A antibody, has been shown in several clinical trials to be effective and safe for the treatment of PsO; however, these studies offer only limited data on the use of secukinumab in patients with chronic illnesses or in special populations. This review explores the use of secukinumab for PsO in special populations, including pregnant women, children, elderly people, patients with erythrodermic PsO, and those with chronic illnesses, including latent tuberculosis, hepatitis B and C, HIV, multiple sclerosis, and malignancies.
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