ANALISIS INTERDEPENDENSI FOREIGN DIRECT INVESTMENT (FDI) DENGAN VARIABEL MAKRO EKONOMI

ABSTRAK Tujuan utama dari penelitian ini adalah untuk menganalisis interdependensi antara FDI dengan beberapa variabel yang lain, seperti PDB, Trade, Nilai Tukar, dan Tingkat bunga. Model VAR digunakan untuk menunjukkan pandangan yang komprehensif dari interdependensi ini. Hasil empiris menunjukkan bahwa melalui model VAR, interdependensi antara variabel FDI, PDB, Trade, Nilai Output Industri, Nilai Tukar dan Tingkat Suku Bunga telah diteliti dalam hubungan jangka panjang melalui kointegrasi vektor dan jangka pendek yang berdampak pada model VAR. Korelasi dinamis variabel telah diperoleh dengan analisis varian dan analisis respon impuls. Beberapa implikasi besar muncul dari hasil penelitian. Jika pemerintah Indonesia berkeinginan mendorong FDI dan pertumbuhan ekonomi, hal ini dapat dilakukan dengan output dan nilai tukar. Dalam jangka pendek maupun jangka panjang, keduanya sangat penting untuk stabilitas ekonomi. Kata Kunci : FDI, Pertumbuhan ekonomi, variabel makro dan model VARBanda Ace

Inibizione del TNFα in pazienti con anticorpi anti-Ro/SSA e artrite reumatoide: Analisi clinica e sierologica = TNF α inhibition in anti-Ro/SSA positive patients with rheumatoid arthritis: Clinical and immunological effects

Objective: to analyse efficacy and safety of anti-TNF \u3b1 treatment in 17 patients with rheumatoid arthritis (AR) and anti-Ro antibodies, in order to detect difference in clinical and immunological response. Methods: 322 patients, affected by RA and treated with anti-TNF \u3b1 drugs, were considered, searching every 6-12 months ANA, anti-dsDNA and anti-ENA antibodies. Seventeen were anti-Ro positive and 305 anti-Ro negative before starting treatment. Results: anti-Ro positive subjects showed active arthritis at baseline (mean DAS: 5), with frequent extra-articular features, such as ocular and oral sicca symptoms. They showed rapid and stable improvement during the treatment, without significant difference compared to anti-Ro negative group. A good clinical Eular response was shown in 46% of anti-Ro negative subjects, steady stable during time. On the contrary, fewer anti-Ro positive patients seem to be "good" responders. RA remission (DAS <1,6) was achieved in 9-25% of anti-Ro positive and 21-29% of anti-Ro negative, without significant difference. Antinuclear antibodies tend to increase in both groups, during the time. Anti-DNA increased to 40% of anti-Ro positive sera since 6thmonth, while they slightly increased in first 12 months in anti-Ro negative ones, then decreased to baseline value. No differences were shown about the frequency and reasons of anti-TNF \u3b1 withdrawal, except for cutaneous lupus-like disease, more detected in anti-Ro positive group. Conclusions: anti-TNF \u3b1 drugs are effective in anti-Ro positive RA as well as other RA patients. Anti-DNA positivity and lupus-like disease were more frequently observed in anti-Ro positive group

Efficacy and safety of anti-TNF agents in the Lombardy rheumatoid arthritis network (LORHEN) = Efficacia e sicurezza degli agenti anti-TNF nel registro Lombardo (LORHEN)

L\u2019artrite reumatoide (AR) \ue8 una patologia ad andamento cronico, caratterizzata da sinovite persistente, progressiva distruzione delle strutture articolari e disabilit\ue0. Gli agenti biologici anti-Tumor Necrosis Factor-\u3b1 (TNF-\u3b1) (etanercept, infliximab e adalimumab) sono dotati di attivit\ue0 anti-infiammatoria, mediata dalla neutralizzazione del TNF-\u3b1, e presentano alcuni importanti vantaggi rispetto ai \u201cDisease-Modifying Anti-rheumatic Drugs\u201d DMARDs. Gli agenti-anti-TNF-\u3b1 sia in monoterapia sia in associazione al methotrexate (MTX), agiscono pi\uf9 rapidamente rispetto ai DMARDs e sono in grado di ridurre l\u2019attivit\ue0 di malattia non solo nei pazienti che hanno una risposta parziale ai farmaci di fondo, ma anche in quelli non responsivi. Nello stesso momento in cui in Europa veniva approvato il terzo farmaco anti-TNF per trattare i pazienti affetti da artrite reumatoide (AR), la Societ\ue0 Italiana di Reumatologia (SIR) avviava un database per registrare e monitorare i pazienti affetti da AR trattati con i farmaci anti-TNF. Fin dal 1999, tutti i pazienti affetti da AR secondo i criteri dell\u2019American College of Rheumatology (ACR) trattati con almeno una dose di farmaco anti-TNF presso quattro Centri di Reumatologia siti in Lombardia (nord est Italia) sono stati inclusi nel registro Lombardy Rheumatology Network (LORHEN) per valutare l\u2019efficacia e la sicurezza dei tre agenti anti-TNF attualmente in commercio durante i primi tre anni di trattamento.Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic synovitis and bone damages, which consist of joint destruction. Clinical trials have shown that anti-tumour necrosis factor (TNF) drugs are effective in patients with rheumatoid arthritis (RA) refractory to disease-modifying antirheumatic drugs (DMARDs). At about the same time as the European approval of the third anti-TNF agent for treating rheumatoid arthritis (RA) patients, the Italian Society of Rheumatology (Societ\ue0 Italiana di Reumatologia [SIR]) started a database for the registration and active follow-up of patients with RA treated with biological response modifiers. Since 1999, all patients with RA (ACR criteria) and treated with at least one dose of an anti-TNF agent at four Rheumatology Centres in Lombardy (northwest Italy) have been included in the Lombardy Rheumatology Network (LORHEN) registry in order to track the efficacy and safety of the three available TNF inhibitors during the first three years of treatment

Efficacy and safety of anti-TNF agents in the Lombardy rheumatoid arthritis network (LORHEN)

Clinical trials have shown that anti-tumour necrosis factor (TNF)-α drugs are effective in patients with rheumatoid arthritis (RA) refractory to disease- modifying antirheumatic drugs (DMARDs) (1-4). At about the same time as the European approval of the third anti-TNFα agent (adalimumab) for treating RA patients, the Italian Society of Rheumatology (Societa Italiana di Reumatologia [SIR]) started a database for the registration and active follow-up of RA patients treated with biological response modifiers, which contains all of the demographic and clinical parameters, as well as the therapeutic data, usually needed to follow RA patients..

Effectiveness of Golimumab as Second Anti-TNFα Drug in Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis in Italy: GO-BEYOND, a Prospective Real-World Observational Study

In this prospective observational study, data were collected from 34 rheumatology clinics in Italy in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who started golimumab (GLM) as a second anti-TNFα drug. The primary objective was to evaluate the effectiveness of GLM after 6 months. Changes in quality of life using the EQ-5D-5L were also assessed. A total of 194 patients aged 53.2 ± 12 years started GLM as a second anti-TNF drug: 39 (20.1%) with RA, 91 (46.9%) with PsA and 64 (32.9%) with axSpA. After 6 months of GLM treatment, 68% of RA patients achieved low disease activity (LDA; DAS28-CRP ≤ 3.2), 31.9% of PsA patients achieved minimal disease activity and 32.5% of axSpA patients achieved LDA (ASDAS-CRP < 2.1). Good/moderate EULAR response was achieved in 61.9% and 73.8% of patients with RA and PsA, respectively, and 16% of axSpA patients achieved a 50% improvement in BASDAI. Across all indications, improvements in disease activity measures and EQ-5D-5L domains were observed over 6 months. The main reasons for GLM interruption were lack/loss of efficacy (7.2%) or adverse events (2%). This study confirms the effectiveness of GLM as a second-line anti-TNF for the treatment of RA, PsA and axSpA in a real-world setting in Italy

Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population

Introduction This 28-week, phase IIIb study assessed safety and maintenance of response to certolizumab pegol (CZP) in a diverse population of rheumatoid arthritis (RA) patients, stratified by prior anti-TNF exposure, concomitant methotrexate (MTX) use and disease duration. The ability to predict achievement of low disease activity (LDA) at week 28 from improvements in Disease Activity Score 28 (DAS28), erythrocyte sedimentation rate (ESR), swollen joint count (SJC) and Clinical Disease Activity Index (CDAI) up to week 12 was assessed. Methods The 28-week study population included all patients who completed the double-blind (DB) phase and entered the open-label (OL) phase, receiving 200 mg CZP every 2 weeks (Q2W) ≥16 weeks. In the 12-week DB period, patients with active RA and an inadequate response to ≥1 disease-modifying antirheumatic drug (DMARD) were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4 then 200 mg Q2W) or placebo (Q2W), stratified by prior anti-TNF use, concomitant use of MTX and disease duration (<2 years vs. ≥2 years). Results A total of 955 patients entered the OL phase. At week 28, similar clinical improvements were seen in those receiving CZP throughout (CZP → CZP; n = 771) and those receiving placebo during the DB phase and switching to CZP in the OL phase (placebo → CZP; n = 184) (ACR20 response rate = 59.7 % vs. 53.3 %; ACR50/ACR70 response rates were also similar). Effect of CZP treatment was similar regardless of prior anti-TNF use, disease duration and concomitant DMARDs, based on ACR20 response rates. The percentage of patients achieving DAS28(ESR) LDA at week 28 was calculated for DAS28(ESR), SJC or CDAI responders at earlier time points. Reductions from baseline (Δ) of DAS28(ESR) <1.2, ΔSJC <25 % or ΔCDAI <10 by week 12 were associated with <9 % chance of achieving LDA at week 28 regardless of prior anti-TNF exposure. Adverse event rates were similar for placebo → CZP and CZP → CZP patients, with no new safety signals identified. Conclusions A diverse population of RA patients with varying disease duration showed rapid and sustained clinical improvements on CZP treatment, regardless of prior anti-TNF or concomitant DMARD use. Failure to achieve improvements in DAS28(ESR), SJC or CDAI within the first 12 weeks of CZP therapy was associated with a low chance of achieving LDA at week 28. No new safety signals were observed. Trial registration ClinicalTrials.gov, NCT00717236, 15 July 200

Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study.

OBJECTIVES: To compare the effectiveness of rituximab versus an alternative tumour necrosis factor (TNF) inhibitor (TNFi) in patients with rheumatoid arthritis (RA) with an inadequate response to one previous TNFi. METHODS: SWITCH-RA was a prospective, global, observational, real-life study. Patients non-responsive or intolerant to a single TNFi were enrolled ≤4 weeks after starting rituximab or a second TNFi. Primary end point: change in Disease Activity Score in 28 joints excluding patient's global health component (DAS28-3)-erythrocyte sedimentation rate (ESR) over 6 months. RESULTS: 604 patients received rituximab, and 507 an alternative TNFi as second biological therapy. Reasons for discontinuing the first TNFi were inefficacy (n=827), intolerance (n=263) and other (n=21). A total of 728 patients were available for primary end point analysis (rituximab n=405; TNFi n=323). Baseline mean (SD) DAS28-3-ESR was higher in the rituximab than the TNFi group: 5.2 (1.2) vs 4.8 (1.3); p<0.0001. Least squares mean (SE) change in DAS28-3-ESR at 6 months was significantly greater in rituximab than TNFi patients: -1.5 (0.2) vs -1.1 (0.2); p=0.007. The difference remained significant among patients discontinuing the initial TNFi because of inefficacy (-1.7 vs -1.3; p=0.017) but not intolerance (-0.7 vs -0.7; p=0.894). Seropositive patients showed significantly greater improvements in DAS28-3-ESR with rituximab than with TNFi (-1.6 (0.3) vs -1.2 (0.3); p=0.011), particularly those switching because of inefficacy (-1.9 (0.3) vs -1.5 (0.4); p=0.021). The overall incidence of adverse events was similar between the rituximab and TNFi groups. CONCLUSIONS: These real-life data indicate that, after discontinuation of an initial TNFi, switching to rituximab is associated with significantly improved clinical effectiveness compared with switching to a second TNFi. This difference was particularly evident in seropositive patients and in those switched because of inefficacy