Segurança e Eficácia de Tofacitinib em Pacientes com Artrite Psoriática Ativa: Análise Provisória de OPAL Balance, um Estudo Aberto de Extensão a Longo Prazo
Nash P, Coates LC, Kivitz AJ, Mease PJ, Gladman DD, Covarrubias-Cobos JA, FitzGerald O, Fleishaker D, Wang C, Wu J, Hsu M, Menon S, Fallon L, Romero AB, Kanik KS. - Rheumatol Ther 2020 doi.org/10.1007/s40744-020-00209-4
This 3-year, open-label, LTE study follows PsA patients previously treated in pivotal studies OPAL Broaden and OPAL Beyond. It demonstrates maintained safety and efficacy of tofacitinib up to 36 and 30 months, respectively. No new safety concerns are highlighted.
Previous P3 studies, OPAL Broaden and OPAL Beyond, demonstrated safety and efficacy of 5mg and 10mg tofacitinib BID in PsA. These patients rolled over to OPAL Balance for a period of 36 months. 686 participants were used in this interim analysis.
Safety assessments considered TE AEs, SAEs, deaths, AEs of special interest, and laboratory parameters up to 36 months. Individual criterion each had incidence rates (IRs) calculated, defined by AEs per 100 patient years. Overall, the safety profile in OPAL Balance was consistent with reports from OPAL Broaden and OPAL Beyond trials, with no new concerns identified.
Efficacy assessments considered rheumatologic and dermatologic outcomes, composite outcomes, and patient reported outcomes. ACR20, ACR50, ACR70, and PsARC responses were demonstrated and maintained throughout the study. Most patients who achieved minimal disease activity during treatment sustained this state until month 30. DAPSA scores and HAQ-DI patient reported outcomes showed overall improvement following initial treatment. These improved scores were maintained throughout the study.
Overall, OPAL Balance findings demonstrated a consensus with those of OPAL Broaden and OPAL Beyond. Analyses illustrated a safety of 5mg and 10mg tofacitinib BID up to 36 months. Efficacy of these treatment groups was noted up to a period of 30 months, with varying response rates, MDA achievement, and improved patient reported outcomes during treatment being maintained in the cohort throughout the study.