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Dermatoses of Pregnancy
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Hannah J. Anderson, Dana Correale, Jason B. Lee
When IH is insufficiently controlled with CS alone, the next therapeutic option is cyclosporine A (CsA). Doses of 3–10 mg/kg/day have been reported in the treatment of IH [60–62]. Again, medication should be tapered to the lowest possible dose that results in control of the disease. The mechanism of action is inhibition of calcineurin with resultant decrease in interleukin-2 production by CD4+ T cells. CsA also inhibits interferon-γ production by T cells. CsA is pregnancy category C. The most serious adverse effects are renal dysfunction and hypertension [16]. Renal function and blood pressure should be monitored during therapy. In a study of transplant recipients treated with CsA during pregnancy there was no evidence of teratogenicity [63]. However, 44.5% of infants were born at less than 37 weeks’ gestation and 44.3% weighed less than 2500 g at birth [63]. CsA is excreted in human breast milk and breastfeeding should be avoided during therapy. Biologic therapies may be considered as an alternative to cyclosporine or next-in-line therapy. Tumor necrosis factor (TNF) α inhibitors and ustekinumab are pregnancy category B drugs. As no significant pregnancy adverse outcomes have been observed, TNFα inhibitors such as infliximab may be considered, even as the first-line therapy [64]. No human safety data during pregnancy are available for newer biologic agents such as brodalumab, ixekizumab, guselkumab, secukinumab, and tildrakizumab, but animal studies showed no adverse effects [16].
Targeting IL-23/IL-17 Axis for Treatment of Psoriasis and Psoriatic Arthritis
Published in Siba P. Raychaudhuri, Smriti K. Raychaudhuri, Debasis Bagchi, Psoriasis and Psoriatic Arthritis, 2017
Subhashis Banerjee, Philip Mease
Guselkumab was evaluated at the above dosing in a 149-patient placebo-controlled Phase 2 trial in patients with PsA (guselkumab:placebo 2:1), >90% of whom were biologic naive [23]. At the primary end point at week 24, there was improvement in both joint and skin outcomes, with significantly higher ACR20 rates (58% vs. 18%) and PASI 90 rates (66% vs. 6%) in guselkumab versus placebo arms, respectively. Significant improvements were also noted in dactylitis and enthesitis in those patients with baseline dactylitis or enthesitis. In addition, significant improvements were observed in Health Assessment Questionnaire Disability Index (HAQ-DI) and 36-Item Short Form Health Survey (SF-36) scores. The incidence of AEs was comparable between the two groups (guselkumab 36% vs. placebo 33%), with only two serious AEs reported (knee injury and myocardial infarction).
Biologic therapies in the pipeline
Published in M. Alan Menter, Caitriona Ryan, Psoriasis, 2017
Molly Campa, Pablo Michel, Caitriona Ryan
Guselkumab (Janssen, Beerse, Belgium) is a fully human immunoglobulin G (IgG)1λ monoclonal antibody targeting the unique p19 subunit of IL-23. A multicenter, phase II, double-blind, placebo-controlled, active-comparator trial comparing guselkumab, adalimumab, and placebo found guselkumab to be superior to placebo and superior to adalimumab at higher doses.8 Patients were randomized to one of seven treatment groups: 5 mg guselkumab every 12 weeks, 15 mg guselkumab every 8 weeks, 50 mg guselkumab every 12 weeks, 100 mg guselkumab every 8 weeks, 200 mg guselkumab every 12 weeks, 80 mg adalimumab every other week, and placebo.8 The percentage of patients achieving a Physician Global Assessment (PGA) score of 0 or 1 (the primary end point) was significantly higher in all guselkumab groups than in placebo and significantly higher than the adalimumab group with 50, 100, and 200 mg doses of guselkumab: 34% in the 5 mg group, 61% in the 15 mg group, 79% in the 50 mg group, 86% in the 100 mg group, 83% in the 200 mg group, and 7% in the placebo group, compared with 58% in the adalimumab group.8 At week 16, the PASI 75 response rates were significantly greater at every dose of guselkumab compared with placebo: 44% at 5 mg dose, 76% at 15 mg dose, 81% at 50 mg dose, 79% at 100 mg dose, and 81% at 200 mg dose versus 5% in the placebo group.8 Seventy percent of the adalimumab-treated patients achieved a PASI 75 response but the statistical significance compared with guselkumab-treated patients was not reported.8 Phase III trials are ongoing to assess the response of patients with moderate-to-severe psoriasis to guselkumab compared with ustekinumab and adalimumab.9–11
Guselkumab for treatment of moderate-to-severe plaque psoriasis: real-life effectiveness and drug-survival for up to 148 weeks
Published in Expert Opinion on Biological Therapy, 2023
Marco Galluzzo, Lorenzo Marcelli, Laura Vellucci, Claudia Paganini, Virginia Maffei, Lorenzo Tofani, Alfredo Belcastro, Luca Bianchi, Marina Talamonti
In all, 151 patients with moderate-to-severe plaque psoriasis were included in this study. Data were analyzed on 122 patients who were treated with at least two doses of guselkumab for>12 weeks (Table 1). The mean age of the study population was 51.5 (SD 14.6) years; 52.6% of patients were male. The mean disease duration was 24 (SD 15.9) years; nineteen patients had a disease onset at ≤12 years of age, 17 patients were between 13 and 17 years of age, while the remainder of the patient population had disease onset as adults (≥18 years). Mean BMI was 28.6 (SD 6.1) kg/m2, and 32.8% of patients were obese; 31.1% of patients had hypertension. In addition, 64.8% of patients had received prior biologic therapy (38 patients had received one prior biologic, 24 patients had received two, 10 patients had received three, and 7 patients had received≥4 prior biologics), and 35 patients received guselkumab after failing therapy with ustekinumab. At the time of analysis, 122 (100%), 107 (87.7%), 93 (76.2%), 77 (63.1%), 69 (56.5%), 51 (41.8%) and 37 (30.3%) patients had completed 12 weeks, 28 weeks, 52 weeks, 76 weeks, 100 weeks, 124 weeks, and 148 weeks of guselkumab treatment, respectively.
Real-world practice indirect comparison between guselkumab, risankizumab, and tildrakizumab: results from an Italian 28-week retrospective study
Published in Journal of Dermatological Treatment, 2022
Matteo Megna, Nello Tommasino, Luca Potestio, Teresa Battista, Angelo Ruggiero, Matteo Noto, Gabriella Fabbrocini, Lucia Genco
An Italian single-center retrospective observational study enrolling moderate-to-severe psoriasis patients attending the Psoriasis Care Center of the University of Naples Federico II, Italy, from November 2019 to November 2021 was performed to compare the efficacy and safety in real-life of guselkumab, tildrakizumab, and risankizumab, particularly focusing on difficult to treat areas. Inclusion criteria were: (i) age ≥18 years, (ii) moderate-to-severe plaque psoriasis, (iii) clinical manifestations in at least one of the so-called difficult-to-treat areas among scalp, palms and soles, nails, lower limbs, and genitals, and (iv) patients treated with guselkumab, tildrakizumab, or risankizumab. Patients were treated with a standard dose of guselkumab (100 mg administered by subcutaneous injection at Week 0 and Week 4, and then a maintenance dose every 8 weeks) or tildrakizumab (100 mg administered by subcutaneous injection at Week 0 and Week 4 followed by a maintenance dose every 12 weeks) or risankizumab (two injections of 75 mg subcutaneously at Week 0, Week 4, and then every 12 weeks).
Cost per responder analysis of guselkumab versus targeted therapies in the treatment of moderate to severe plaque psoriasis in Germany
Published in Journal of Dermatological Treatment, 2022
Matthias Augustin, Daniel Wirth, Jörg Mahlich, Alicia N. Pepper, Cheryl Druchok
Guselkumab is a targeted therapy indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy (16). It is a fully human monoclonal antibody that binds selectively to the p19 subunit of the extracellular IL-23 protein with high specificity and affinity. Compared with the mechanisms of action for other targeted therapies, inhibition of IL-23 may provide a more targeted and upstream blockade of the inflammatory pathway involved in psoriasis. Clinical trials have demonstrated superior short-term efficacy versus placebo and adalimumab, and superior long-term efficacy versus adalimumab and secukinumab (17–19). Compared with other targeted therapies, network meta-analyses (NMAs) suggest guselkumab is one of the most effective therapies (20).