Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia

被引:11
作者
Najarian, Dean [1 ]
Turkoz, Ibrahim [2 ,8 ]
Knight, R. Karl
Galderisi, Silvana [3 ]
Lamaison, Hector F. [4 ]
Zalitacz, Piotr [5 ]
Aravind, Suresh [2 ,7 ]
Richarz, Ute [6 ]
机构
[1] Janssen Sci Affairs LLC, Titusville, NJ USA
[2] Janssen Res & Dev LLC, Titusville, NJ USA
[3] Univ Campania Luigi Vanvitelli, Naples, Italy
[4] Natl Univ La Plata UNLP, Dept Psychiat, Buenos Aires, Argentina
[5] Gorlice Specialist Hosp, Psychiat Unit, Gorlice, Poland
[6] Cilag Int, Janssen Res & Dev, Gubelstr, Zug, Switzerland
[7] Dural Consulting LLC, St Petersburg, FL USA
[8] Janssen Res & Dev LLC, 1125 Trenton Harbourton Rd, Titusville, NJ 08560 USA
关键词
Long-term efficacy; schizophrenia; long-acting injectable; open-label extension; paliperidone palmitate 6-month; ACTING INJECTABLE ANTIPSYCHOTICS; PALMITATE; RELAPSE; REHOSPITALIZATION; NONADHERENCE; MEDICATION; ADHERENCE; PLACEBO;
D O I
10.1093/ijnp/pyad028
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone palmitate 3-month in preventing relapse in patients with schizophrenia in a phase 3 double-blind (DB) study (NCT03345342). Here, we report long-term efficacy and safety results from a 2-year single-arm, open-label extension (OLE; NCT04072575) of this DB study. Methods Participants who completed the DB study without relapse were enrolled and followed-up every 3 months up to 2 years. Participants received 4 PP6M gluteal injections (700/1000 mg eq.) at baseline, 6-month, 12-month, and 18-month visits. Efficacy endpoints included assessment of relapse, Positive and Negative Syndrome Scale total score, Personal and Social Performance score, and Clinical Global Impression-Severity scale change from baseline. Safety was assessed by treatment-emergent adverse events (TEAEs), physical examinations, and laboratory tests. Results Of 178 participants enrolled, 154 (86.5%) completed the OLE (mean age: 40.4 years, men: 70.8%; mean duration of PP6M exposure during OLE: 682.1 days). Overall, 7/178 (3.9%) participants relapsed between 20 and 703 days after enrolment. Mean (SD) changes from baseline to endpoint were as follows: Positive and Negative Syndrome Scale total score, 0.7 (8.22); Clinical Global Impression-Severity, 0.0 (0.51); and Personal and Social Performance Scale, 0.5 (7.47). Overall, 111/178 participants (62.4%) reported & GE;1 TEAE; most common (>5%) TEAEs were headache (13.5%) and increased blood prolactin/hyperprolactinemia (18.0%); 8/178 (4.5%) participants experienced serious TEAEs, and 6/178 (3.4%) participants withdrew due to TEAEs. No deaths were reported. Conclusions The relapse rate observed with PP6M during the 2-year OLE was low (3.9%). Clinical and functional improvements demonstrated in the DB study were maintained during OLE, and no new safety concerns were identified.
引用
收藏
页码:537 / 544
页数:8
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