A post-marketing surveillance study on the effectiveness and safety of paliperidone ER among Filipino adult patients diagnosed with Schizophrenia

BACKGROUND: Schizophrenia affects 7 people per 1000 adult population worldwide and is a severe form of mental illness common in age group 15-35 year old. Paliperidone is the active metabolite of risperidone and was approved for treatment of schizophrenia in the Philippines by the Food and Drug Administration (FDA) in 2007. The drug has been shown to be safe and effective in clinical trials but no local study has investigated its effect among Filipino patients. Hence, the general objective of this study was to assess the safety and effectiveness of paliperidone ER among Filipino patients diagnosed with schizophrenia. METHODS: The study was a non-randomized, non-comparative, open-label trial involving adult patients seen at initial consult and at the end of study visit. Study duration was eight weeks and was conducted for three years as required by the FDA. The primary outcome for the study was overall severity of the illness at the initial visit and end visit (visit 2) using the Clinical Global Impression tool (CGI-S). This rating scale was used to rate the severity of a subject's pyschotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). RESULTS: A total of 641 Filipino adults were enrolled in the study. Ninety one percent (N=586) had completed the follow-up into the second or end visit resulting in a 9% drop out for the duration of the study. Follow-up period had an average of 58.05 (SD+=9.36) days ranging from a minimum of 4 to a maximum of 98 days. Clinicians' assessment of the severity of illness showed that majority had shown improvement from their baseline clinical state with the use of Paliperidone ER. The proportion of severely ill had decreased by 15% while the proportion of those who were markedly ill had decreased by 15% while the proportion of those who where markedly ill had decreased by 35% by the end of the second visit. Overall, after eight weeks of paliperidone treatment, there was a decrease of 58% in the proportion of subjects evaluated to be mildly ill, borderline mentally ill and normal at the end of the second visit. This means that there was a marked improvement in patients observed and reported symptoms, behavior and functions as assessed by physicians using CGI. Fifteen percent of study participants experienced at least one non-serious adverse event during the study. The five most common non-serious adverse events observed include sleeplessness, extrapyramidal symptoms described as Pseudo parkinsonian tremors, stiffness of body and DOB/EPS reaction hand tremors, depression, akathisia and dizziness. CONCLUSION: Paliperidone ER administered at 6 mg single dose improved symtoms and clinical signs among adult Filipinos diagnosed with schizophrenia who are moderately and markedly ill. The drug is will-tolerated, but the dose may need to be increased for more severely ill patients. Paliperidone ER is one of the current useful options for the treatment of patients with schizophrenia.

Ustekinumab for adult Filipino patients with moderate to severe chronic plaque psoriasis: A clinical series

BACKGROUND: Psoriasis is a chronic inflammatory disease occurs worldwide. At the Philippine General Hospital dermatology clinic, psoriasis accounted for 2.2% -2.4 % of new consults seen in 2004-2010. Its pathogenesis remains obscure but current studies indicate that activated Thai and Thai response mechanisms mediate inflammation and are implicated as key players in psoriasis genesis. Ustekinumab is a fully human monoclonal antibody that targets two interleukins (IL): IL-12 and IL-23 which influence T-cell differentiation into Thi and Thai, respectively. These naturally occurring proteins help regulate the immune system secondary to their role in linking innate and adaptive immune responses.CASE SERIES: This is a retrospective chart review on the use of ustekinumab in 22 adult Filipinos (10 males and 12 females) conducted at six (6) dermatologists' clinics in 2010. Included were patients enrolled in the Named Patient Program (NPP) of Janssen Pharmaceutical Companies of Johnson & Johnson Philippines, diagnosed with moderate to severe long-standing plaque psoriasis and contraindicated for, or with inadequate response to, conventional systemic treatment. Patients received ustekinumab subcutaneously at loading doses of 45mg during the initial visit and at four weeks. Subsequently, it was given every twelve weeks. For patients who weighed 100 kg or more, 90mg of ustekinumab was administered. Clinical responses to the drug were assessed using Psoriasis Area and Severity Index (PASI) at initial visit and at the end of the program (52 weeks). At the end of the one-year program period, the median (range) PASI score of patients was 1.50 (0-29.2). Sixteen of the twenty-two subjects (72.73%) were able to achieve ±75% improvement from baseline (PASI 75). There was a significant (94.52%) reduction in median PASI scores of the patients from baseline to end visit (p CONCLUSION: Ustekinumab was shown to significantly reduce the median PASI scores of 22 adult Filipino patients with moderate to severe plaque psoriasis. It was also shown to be well tolerated, with relatively mild adverse events.