Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

Efficacy of brodalumab in the treatment of scalp and nail psoriasis: results from three phase 3 trials.

Revista The Journal of dermatological treatment
Año 2022
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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INTRODUCTION: We evaluated the efficacy of brodalumab in patients with nail or scalp psoriasis in three phase 3 studies (AMAGINE-1/-2/-3). METHODS: In AMAGINE-1, scalp clearance, measured by the psoriasis scalp severity index (PSSI), was reported for patients who received brodalumab 210 mg every 2 weeks (Q2W) or placebo through 12 weeks. In AMAGINE-2/-3, nail clearance, measured by the nail psoriasis severity index (NAPSI), was reported for patients receiving either brodalumab 210 mg Q2W or ustekinumab continuously through 52 weeks. RESULTS: At week 12, significantly more patients receiving brodalumab achieved 75% and 100% improvement rates from baseline PSSI and had lower mean PSSI across 12 weeks compared with placebo, with significant improvement in PSSI evident with brodalumab 210 mg Q2W vs placebo by week 2. Across 52 weeks, patients receiving brodalumab achieved significantly greater complete clearance of nail psoriasis (NAPSI 0), lower mean NAPSI, and higher mean percent improvement rates from baseline NAPSI than patients receiving ustekinumab. At week 52, 63.8% of patients receiving brodalumab achieved NAPSI 0 vs 39.1% of patients receiving ustekinumab. CONCLUSIONS: Brodalumab was associated with clearance of scalp psoriasis through 12 weeks and improvements in nail psoriasis, including complete nail clearance, through 52 weeks.

Estudio primario

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A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.

Revista The British journal of dermatology
Año 2021
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Síntesis amplia Síntesis amplias (1 referencia) 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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BACKGROUND: Significantly more patients with moderate-to-severe plaque psoriasis treated with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head trial achieved 100% improvement in Psoriasis Area and Severity Index (PASI 100) at week 12. OBJECTIVES: To compare skin and nail clearance and patient-reported outcomes for ixekizumab vs. guselkumab, up to week 24. METHODS: IXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined as static Physician's Global Assessment ≥ 3, PASI ≥ 12 and involved body surface area ≥ 10%. Statistical comparisons were performed using the Cochran-Mantel-Haenszel test stratified by pooled site. Time-to-first-event comparisons were performed using Kaplan-Meier analysis, and P-values were generated using adjusted log-rank tests stratified by treatment group. Cumulative days at clinical and patient-reported responses were compared by ancova. The trial was registered with ClinicalTrials.gov (NCT03573323). RESULTS: Of the 1027 patients randomly assigned, 90% completed the trial (465 of 520 ixekizumab and 459 of 507 guselkumab). As early as week 2 and through week 16, more patients on ixekizumab achieved PASI 100 (P < 0·01). At week 24, ixekizumab was noninferior to guselkumab (50% vs. 52%, difference -2·3%), with no statistically significant difference in PASI 100 (P = 0·41). More patients receiving ixekizumab showed completely clear nails at week 24 (52% vs. 31%, P = 0·007). The median time to first PASI 50/75/90 and PASI 100 were 2 and 7·5 weeks shorter, respectively, for patients on ixekizumab vs. guselkumab (P < 0·001). Patients on ixekizumab also had a greater cumulative benefit, with more days at PASI 90 and 100, with Dermatology Life Quality Index of 0 or 1, and itch free (P < 0·05). The frequency of serious adverse events was 3% for each group, with no new safety signals. CONCLUSIONS: Ixekizumab was noninferior to guselkumab in complete skin clearance and superior in clearing nails at week 24. Ixekizumab cleared skin more rapidly in patients with moderate-to-severe plaque psoriasis, with a greater cumulative benefit, than guselkumab. Overall, the safety findings were consistent with the known safety profile for ixekizumab.

Estudio primario

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Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S)

Revista Dermatology and therapy
Año 2020
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Introduction: Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks. Methods: In IXORA-S, randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined. Results: Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16–20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE. Conclusions: Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity. Trial Registration: ClinicalTrials.gov identifier; NCT02561806.

Estudio primario

No clasificado

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial.

Revista Journal of the American Academy of Dermatology
Año 2018
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Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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BACKGROUND: Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. OBJECTIVE: This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. METHODS: Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). RESULTS: Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. LIMITATIONS: Patients with less than 5% BSA involvement were not eligible for enrollment. CONCLUSIONS: After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.

Estudio primario

No clasificado

Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials.

Revista JAMA dermatology
Año 2018
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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IMPORTANCE: Psoriasis of the scalp, palms and/or soles, and nails is challenging to treat. OBJECTIVE: To evaluate the effect of guselkumab on psoriasis in specific body regions. DESIGN, SETTING, AND PARTICIPANTS: VOYAGE 1 and VOYAGE 2 were, double-blind, placebo- and adalimumab-controlled studies of guselkumab conducted at 101 and 115 global sites, respectively, from November 3, 2014, to May 19, 2016. Patients had moderate to severe plaque psoriasis (Psoriasis Area and Severity Index score ≥12, Investigator's Global Assessment [IGA] score ≥3, and ≥10% body surface area with psoriasis). This post hoc data analysis was performed from February 10 through November 15, 2017. EXPOSURES: Patients were randomized to guselkumab, 100 mg (weeks 0 and 4, then every 8 weeks); placebo followed by guselkumab, 100 mg, starting at week 16; or adalimumab (80 mg [week 0] and 40 mg [week 1, then every 2 weeks]). MAIN OUTCOMES AND MEASURES: Efficacy was assessed through week 24. End points included numbers of patients achieving scores of 0 or 1 (clear or near clear) or 0 (clear) on the scalp-specific IGA (ss-IGA), Physician's Global Assessment of the hands and/or feet (hf-PGA), and fingernail PGA (f-PGA) and percentage of improvement in target Nail Psoriasis Severity Index score. RESULTS: Of 1829 randomized patients (mean [SD] age, 43.6 [12.4] years; 1300 [71.1%] male, 1498 [81.9%] white), 1576 (86.2%) had psoriasis of the scalp; 501 (27.4%), palms and/or soles; and 1049 (57.4%), fingernails. At baseline, 1512 (82.7%), 461 (25.2%), and 928 (50.7%) patients had a score of 2 or higher on the ss-IGA, hf-PGA, and f-PGA, respectively, and were included in the analysis. Guselkumab was superior to placebo based on the proportion of patients achieving an ss-IGA score of 0 or 1 (560 [81.8%] vs 43 [12.4%]) at week 16 and to adalimumab (582 [85.0%] vs 329 [68.5%]) at week 24 (both P < .001); 479 (69.9%) in the guselkumab group vs 270 (56.3%) in the adalimumab group achieved an ss-IGA score of 0 (all P < .001). An hf-PGA score of 0 or 1 was achieved by 154 patients (75.5%) in the guselkumab group vs 15 (14.2%) in the placebo group at week 16 and 164 (80.4%) in the guselkumab group vs 91 (60.3%) in the adalimumab group at week 24; 153 (75.0%) in the guselkumab group vs 76 (50.3%) in the adalimumab group achieved an hf-PGA score of 0 (all P < .001). An f-PGA score of 0 or 1 was achieved by 196 patients (46.7%) in the guselkumab group vs 32 (15.2%) in the placebo group at week 16 (P < .001) and 252 (60.0%) in the guselkumab group vs 191 (64.3%) in the adalimumab group at week 24 (P = .11); 115 (27.4%) in the guselkumab group vs 83 (27.9%) in the adalimumab group achieved an f-PGA score of 0 (P = .63). CONCLUSIONS AND RELEVANCE: Compared with adalimumab, guselkumab was associated with significant improvement in psoriasis on the scalp and palms and/or soles; magnitude of improvement in fingernails did not differ between treatments. These results may help dermatologists make treatment decisions for patients with psoriasis in difficult-to-treat body regions. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02207231 and NCT02207244.

Estudio primario

No clasificado

Base enfermedad de las uñas en los pacientes con psoriasis de moderada a severa y la respuesta al tratamiento con infliximab durante 1 año.

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Revista Journal of the American Academy of Dermatology
Año 2008
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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ANTECEDENTES: A pesar de la psoriasis ungueal ocurre con frecuencia en los pacientes con lesiones cutáneas de psoriasis, tratamientos efectivos son limitados. OBJETIVO: Se evaluó aparición de la psoriasis ungueal según el tipo y la incidencia del despacho de uñas utilizando el Índice de Gravedad de la psoriasis ungueal. MÉTODOS: Se realizó un 50 semanas de duración, estudio de fase III en el que 378 pacientes con psoriasis moderada a grave fueron aleatorizados 4:1 a infliximab (5 mg / kg) o placebo en las semanas 0, 2, 6 y cada 8 semanas hasta la semana 46, cruce con placebo de infliximab en la semana 24. Resultados: De los 373 pacientes evaluados, 305 (81,8%) tenían psoriasis ungueal basal. La imagen en miniatura a la derecha era más a menudo el peor clavo involucrados, y las picaduras y onicólisis fueron las lesiones más comunes. Entre los pacientes con psoriasis de uñas línea de base, 6,9%, 26,2%, y 44,7% en el grupo de infliximab tenido clavo despacho de la enfermedad en las semanas 10, 24, y 50, respectivamente, frente a 5,1% en el grupo de placebo en la semana 24 (P <0,001 ). Media mejoras porcentuales en Nail Psoriasis Severity Index puntuación en las semanas 10 y 24 fueron de 26,8% y 57,2%, respectivamente, en el grupo de infliximab en comparación con -7,7% y -4,1%, respectivamente, en el grupo placebo (ambos p <0,001). En la semana 24, la media de las mejoras por ciento en la matriz de las uñas con uñas y características de cama eran 52,9% y 69,2%, respectivamente (frente al -1,9% y 18,4% para placebo, p <0,001). Limitaciones: El estudio no evaluó la respuesta clavo allá de 1 año. Conclusiones: Los pacientes con psoriasis recibir infliximab experimentaron marcadas y sostenidas mejoras de uñas.