Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial

Autor: Ritchlin, C., Rahman, P., Kavanaugh, A., McInnes, I.B., Puig, L., Li, S., Wang, Y., Shen, Y.-K., Doyle, M. K., Mendelsohn, A. M., Gottlieb, A. B., Perate, M., Whitman, M., Dooley, L. T., Alten, R., Birbara, C., Boh, E., Braun, J., Budd, J., Chattapadhyay, C., Chudzik, D., Claudepierre, P., Cooper, R., Drescher, E., Dutz, J., Edwards, C., Elewski, B., El-Kadi, H., Erlacher, L., Flipo, R., Fretzin, S., George, E., Gladstein, G., Griffin, R., Grisanti, M., Guenther, L., Gulliver, W., Hobbs, K., Huang, E., Ilivanova, E., Jeka, S., Khraishi, M., Kokhan, M., Korman, N., Kunynetz, R., Leonardi, C., Lessard, C., Lindquist, U., Martin, A., Matheson, R., Murphy, F., Nasonov, E., Palmer, W., Papp, K., Rech, J., Rell-Bakalarska, M., Rich, P., Rosen, C., Rudin, A., Ruppert-Roth, A., Scheinecker, C., Seigel, S., Shaikh, S., Sheeran, T., Shergy, W., Siegel, E., Sierakowski, S., Sofen, H., Szanto, S., Tahir, H., Telegdy, E., Toth, D., Walker, D., Wilson, A., Witt, M., Wollenhaupt, J., Zoschke, D., Zubrzycka, A.
Jazyk: angličtina
Rok vydání: 2014
ISSN: 0003-4967
Popis: Objective: Assess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents.\ud \ud Methods: In this phase 3, multicentre, placebo-controlled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/>100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with \ud \ud Results: More ustekinumab-treated (43.8% combined) than placebo-treated (20.2%) patients achieved ACR20 at week 24 (p\ud \ud Conclusions: The interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.
Databáze: OpenAIRE