11 research outputs found

    A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

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    Treatment of Early Folliculotropic Mycosis Fungoides with Special Focus on Psoralen plus Ultraviolet A

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    Data on the treatment of early folliculotropic mycosis fungoides, a recently defined clinicopathological subgroup of folliculotropic mycosis fungoides with an indolent course, is limited. Treatment outcomes were studied in a retrospective cohort of 47 adults with early folliculotropic mycosis fungoides, with a focus on psoralen plus ultraviolet A (PUVA) monotherapy, including dosimetric data, and the findings were compared with data for PUVA in 18 adults with early-classic mycosis fungoides. PUVA was given to 27 patients with early folliculotropic mycosis fungoides: 70% achieved complete response and 26% partial response. Significantly more treatments were needed to achieve complete response in stage IB compared with stage IA. There was no significant difference in the complete response rate from classic plaque-stage disease, although the early folliculotropic mycosis fungoides group required more treatments to achieve complete response, and a higher cumulative dose of UVA. Thus, PUVA is an effective treatment for early folliculotropic mycosis fungoides. Its complete response rate might be equal to early-classic mycosis fungoides; however, a longer induction phase is needed to achieve complete response

    The Course of Mycosis Fungoides under Cytokine Pathway Blockers: A Multicentre Analysis of Real-life Clinical Data

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    Literature regarding the effect of biologics on the course of mycosis fungoides (MF) is scarce. This multi-centre study analysed retrospective data on 19 patients with MF, who were treated with biologics; 12 for inflammatory conditions coexisting with MF, and 7 for MF misdiagnosed as an inflammatory skin disease. Eight patients were treated with anti-tumour necrosis factor-alpha-monotherapy; 6 had early-stage MF, in 3 patients MF preceded and in 3 MF was diagnosed after initiation of biologics, with no stage-progression or with stable disease, respectively (median treatment time concurrent with MF 57 months). Two patients had advanced stage MF: IIB, treated for 15 months with no stage-progression, and IVA1, treated for 8 months, died of disease 10 months later. The other 11/19 patients received anti-interleukin-17A and/or anti-interleukin-12/23 or anti-interleukin-23 (with/without anti-tumour necrosis factor-alpha/anti-interleukin-4/13), with stage-progression in 8 patients after a median of 8 months' treatment. Although, in general, biologics should be avoided in patients with MF, these results indicate that anti-tumour necrosis factor-alpha-monotherapy might not aggravate the disease course in early-stage patients. Interleukin-17A, interleukin-12/23 and interleukin-23 pathway-blockers may prompt progression of MF

    Comparison of risankizumab and apremilast for the treatment of adult patients with moderate plaque psoriasis eligible for systemic therapy: results from a randomised, open-label, assessor-blinded phase IV (IMMpulse) study

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    BACKGROUND: Treatment with risankizumab has demonstrated superior efficacy to other psoriasis treatments, such as adalimumab, ustekinumab, and secukinumab. OBJECTIVES: This study compared the efficacy and safety of risankizumab and apremilast among adult patients with moderate plaque psoriasis eligible for systemic therapy. It also evaluated the efficacy and safety of switching to risankizumab versus continuing apremilast among patients who did not achieve ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75 non-responders) after 16 weeks of treatment with apremilast. METHODS: This 52-week, phase 4, multicenter, randomised, open-label, efficacy assessor-blinded study (NCT04908475) enrolled patients (≥ 18 years) with a diagnosis of moderate chronic plaque psoriasis (≥ 6 months) and were candidates for systemic therapy. The enrolled patients (1:2) received subcutaneous risankizumab (150 mg, week 0, 4) or oral apremilast (30 mg twice daily). At week 16, all apremilast-treated patients were re-randomised (1:1) to risankizumab or apremilast, stratified by week 16 PASI 75 response. The co-primary outcomes in Period A at week 16 were the achievement of PASI 90 and static Physician\u27s Global Assessment (sPGA) 0/1 with ≥ 2-grade improvement from baseline. At week 52, the primary endpoint in Period B was the achievement of PASI 90 in PASI 75 non-responders with apremilast at week 16. Safety was monitored throughout the study. All patients who received one dose of treatment were included in the efficacy and safety analysis. RESULTS: At baseline, 118 and 234 patients were assigned to receive risankizumab and apremilast, respectively. At week 16, PASI 90 was achieved by 55.9% (95% CI, 47.0%, 64.9%) and 5.1% (95% CI, 2.3%, 8.0%), and sPGA 0/1 by 75.4% (95% CI, 67.7%, 83.2%) and 18.4% (95% CI, 13.4%, 23.3%), respectively. In Period B, among PASI 75 non-responders with apremilast at week 16, 83 switched to risankizumab, and 78 continued apremilast. At week 52, 72.3% (95% CI, 62.7%, 81.9%) who switched to risankizumab achieved PASI 90 versus 2.6% (95% CI, 0.0%, 6.1%) who continued apremilast. The most frequent adverse events (reported in ≥ 5%) in risankizumab-treated patients were COVID-19 and nasopharyngitis. Diarrhoea, nausea, and headache were most frequent among apremilast-treated patients. CONCLUSIONS: For patients with moderate psoriasis, treatment with risankizumab demonstrated superior efficacy compared to apremilast, including those who did not benefit from prior treatment with apremilast. The safety profile of risankizumab was similar to prior studies, and no new safety signals were identified. These results show that risankizumab treatment can significantly improve clinical outcomes in systemic-eligible patients with moderate psoriasis compared to apremilast
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