Estudio primario

No clasificado

Año 2012
Revista The New England journal of medicine
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BACKGROUND:

In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown.

METHODS:

We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0. During the maintenance phase, 145 patients who had a response to ustekinumab at 6 weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 mg) or placebo at weeks 8 and 16. The primary end point was a clinical response at 6 weeks.

RESULTS:

The proportions of patients who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P=0.005 for the comparison with the 6-mg group). The rate of clinical remission with the 6-mg dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% vs. 27.4%, P=0.03) and response (69.4% vs. 42.5%, P<0.001) at 22 weeks. Serious infections occurred in 7 patients (6 receiving ustekinumab) during induction and 11 patients (4 receiving ustekinumab) during maintenance. Basal-cell carcinoma developed in 1 patient receiving ustekinumab.

CONCLUSIONS:

Patients with moderate-to-severe Crohn's disease that was resistant to TNF antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. (Funded by Janssen Research and Development; CERTIFI ClinicalTrials.gov number, NCT00771667.).

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Estudio primario

No clasificado

Año 2010
Revista The New England journal of medicine
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BACKGROUND:

Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor α), for the treatment of psoriasis.

METHODS:

We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-dose etanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI) at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of the treatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12.

RESULTS:

There was at least 75% improvement in the PASI at week 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P = 0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were similar before and after crossover from etanercept to ustekinumab.

CONCLUSIONS:

The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis. (ClinicalTrials.gov number, NCT00454584.) Copyright © 2010 Massachusetts Medical Society.

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Estudio primario

No clasificado

Año 2012
Autores Sánchez-Regaña, M
Revista Actas dermo-sifiliogr. (Ed. impr.)

Este artículo no está incluido en ninguna revisión sistemática

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Ustekinumab es un anticuerpo monoclonal humano anti interleucina 12 y 23. En los ensayos clínicos pivotales quedó probada su eficacia y seguridad a nivel de la psoriasis en placas moderada-severa. Asimismo, cabe destacar que en dichos ensayos se utilizó también el índice de severidad de psoriasis ungueal para evaluar su efectividad en la psoriasis ungueal. Los pacientes tratados en el ensayo PHOENIX 1 (n=545) mostraron que las lesiones ungueales mejoraron de forma progresiva hasta la semana 52, si bien en la semana 12, después de dos dosis de ustekinumab, la mediana de la mejoría de las puntuaciones NASPI respecto al valor basal fue del 25%, llegando al 50% en la semana 24. Por otro lado, desde su reciente incorporación, ustekinumab también se ha empleado en otras formas de psoriasis (pustulosa, palmo-plantar, eritrodérmica) y también en otras enfermedades (pitiriasis rubra pilaris, hidradenitis supurativa y dermatitis atópica) (AU)

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Resumen estructurado de revisiones sistemáticas

No clasificado

Año 2011
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Institute for Health and Clinical Excellence. Ustekinumab for the treatment of adults with moderate to severe psoriasis. London: National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance 180. 2009

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Resumen estructurado de revisiones sistemáticas

No clasificado

Año 2013
Autores [No se listan los autores]
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of an ongoing health technology assessment being undertaken by a member of INAHTA. Links to the published report and any other relevant documentation will be added when available.

CITATION:

Ustekinumab for the treatment of active and progressive psoriatic arthritis. Health Technology Assessment

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Estudio primario

No clasificado

Año 2011
Revista European journal of dermatology : EJD
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Este artículo no tiene resumen

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Resumen estructurado de revisiones sistemáticas

No clasificado

Año 2014
Autores HAYES , Inc
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

Stelara (ustekinumab; Janssen Biotech Inc.) for treatment of psoriatic arthritis Lansdale: HAYES, Inc.. Health Technology Brief Publication. 2013

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Revisión sistemática

No clasificado

Año 2011
Autores Tan JY , Li S , Yang K , Ma B , Chen W , Zha C - Más
Revista The Journal of dermatological treatment
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Objective: To assess the efficacy and safety of ustekinumab for psoriasis. Methods: In this meta-analysis study, we searched The Cochrane Library (2009, 1 issue), MEDLINE (1966 to March 2009), EMBASE (1974 to March 2009), and China Academic Journal Full-text Database (CNKI, 19942009/3), China Biomedical Literature Database (CBM, 19782009/3), Chinese Scientific Journals Database (VIP, 19892008/3), and Wan fang Database (19992009). The quality of included studies was critically evaluated. Data analyses were performed with the Cochrane Collaboration's RevMan 5.0 software. Results: Three randomized controlled trials (RCTs) with a total of 2316 patients were included in the inclusion criteria. The meta-analysis showed significant improvement of the psoriasis area and severity index (PASI), dermatology life quality index (DLQI) score or physician's global assessment when receiving ustekinumab compared with patients receiving placebo, while significant differences were noted between the ustekinumab 45 mg group and the ustekinumab 90 mg group in these indexes. There was no statistical significance with regard to adverse effects. Conclusions: The present study showed ustekinumab to be safe and effective for patients with psoriasis. Future high-quality, long-treatment, placebo-controlled, double-blind trials are needed. © 2011 Informa Healthcare USA on behalf of Informa UK Ltd.

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Estudio primario

No clasificado

Año 2011
Revista The Journal of dermatological treatment
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OBJECTIVE:

To compare the cost per responder of ustekinumab with etanercept based on data from the active comparator ACCEPT trial.

METHODS:

In ACCEPT, patients received ustekinumab 45 mg (n = 209) or 90 mg (n = 347) at weeks 0 and 4 or etanercept 50 mg (n = 347) twice weekly for 12 weeks. The proportions of patients achieving ≥75% improvement in the Psoriasis Area and Severity Index [PASI 75] were determined at week 12. The cost per PASI 75 responder was determined for week 16, a time coinciding with treatment coverage of both drugs and accounting for the different dosing intervals. Costs for 16 weeks of therapy were based on the Wholesale Acquisition Cost (WAC) in the United States. The analysis used weight-based efficacy results for ustekinumab (45 mg for patients ≤ 100 kg; 90 mg for patients > 100 kg) and overall efficacy for etanercept, consistent with the approved dosages.

RESULTS:

A total of 28% of patients weighed > 100 kg. The PASI 75 response rates at week 12 were 72.2% for the ustekinumab 45 mg group in patients ≤ 100 kg, 65.0% for the ustekinumab 90 mg group in patients > 100 kg, and 56.8% for the etanercept group. At week 16, the cost per responder was $17,842 for ustekinumab and $20,077 for etanercept.

CONCLUSION:

The cost per responder was lower for ustekinumab than for etanercept through 16 weeks in psoriasis patients.

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Estudio primario

No clasificado

Año 2020
Revista Farm. hosp

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OBJETIVO:

La enfermedad inflamatoria intestinal es un grupo de trastornos crónicos, inflamatorios y recidivantes que afectan al intestino. En la última década, los fármacos biológicos han supuesto un gran cambio en la terapia de esta enfermedad. Adalimumab, golimumab y ustekinumab son tres de ellos que se administran por vía subcutánea tras su dispensación en los servicios de farmacia de los hospitales. Para que se alcance la efectividad del tratamiento es necesaria una adecuada adherencia al mismo. El objetivo del presente trabajo fue evaluar la adherencia en pacientes que recogían los tres fármacos en el servicio de farmacia de un hospital de tercer nivel.

MÉTODO:

Se realizó un estudio analítico observacional de corte transversal en el que se incluyó a pacientes que recibían tratamiento con los anteriores fármacos durante al menos cuatro meses. Se recogió la tasa de posesión de la medicación proporcionada por el registro de dispensaciones y se seleccionó a los pacientes que presentaron un valor inferior o igual al 85%. A estos pacientes se les aplicó el cuestionario de medida del cumplimiento terapéutico de Morisky-Green.

RESULTADOS:

Se incluyeron 178 pacientes, de los cuales el 60,1% (107) fueron hombres y el 30,9% (55) habían sido tratados con otros fármacos biológicos previamente. La adherencia media, según el registro de dispensaciones, fue del 91,79% y se clasificó a 45 pacientes (25,28%) como mal adherentes (≤ 85%). La no administración en la fecha indica da y el olvido se identificaron como principales razones de la falta de cumplimiento terapéutico según el resultado del test de Morisky-Green. El sexo femenino (odds ratio 0,42; p = 0,013) y la duración del tratamiento (p = 0,002) se asociaron a una peor adherencia a la medicación.

CONCLUSIONES:

El porcentaje de adherencia obtenido resultó elevado en la población de estudio, pero se identificaron pacientes mal cumplidores susceptibles de recibir intervenciones para mejorar su adherencia. No obstante, se debería aumentar la potencia estadística para mejorar la validez de los resultados obtenidos

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