Doses of 20 and 40 mg/day of paroxetine are effective and well tolerated in the treatment of adults with chronic PTSD.

ObjectiveTo examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE).MethodsPooled data were examined from two ongoing open-label studies that enrolled patients who completed BLISS-52 or BLISS-76. Patients received belimumab every four weeks plus SoC. SLICC Damage Index (SDI) values were assessed every 48 weeks (study years) following belimumab initiation (baseline). The primary endpoint was change in SDI from baseline at study years 5–6. Incidences of adverse events (AEs) were reported for the entire study period.ResultsThe modified intent-to-treat (MITT) population comprised 998 patients. At baseline, 940 (94.2%) were female, mean (SD) age was 38.7 (11.49) years, and disease duration was 6.7 (6.24) years. The mean (SD) SELENA-SLEDAI and SDI scores were 8.2 (4.18) and 0.7 (1.19), respectively; 411 (41.2%) patients had organ damage (SDI = 1: 235 (23.5%); SDI ≥ 2: 176 (17.6%)) prior to belimumab. A total of 427 (42.8%) patients withdrew overall; the most common reasons were patient request (16.8%) and AEs (8.5%).The mean (SD) change in SDI was +0.2 (0.48) at study years 5–6 (n = 403); 343 (85.1%) patients had no change from baseline in SDI score (SDI +1: 46 (11.4%), SDI +2: 13 (3.2%), SDI +3: 1 (0.2%)). Of patients without organ damage at baseline, 211/241 (87.6%) had no change in SDI and the mean change (SD) in SDI was +0.2 (0.44). Of patients with organ damage at baseline, 132/162 (81.5%) had no change in SDI and the mean (SD) change in SDI was +0.2 (0.53). The probability of not having a worsening in SDI score was 0.88 (95% CI: 0.85, 0.91) and 0.75 (0.67, 0.81) in those without and with baseline damage, respectively (post hoc analysis).Drug-related AEs were reported for 433 (43.4%) patients; infections/infestations (282, 28.3%) and gastrointestinal disorders (139, 13.9%) were the most common.ConclusionPatients with SLE treated with long-term belimumab plus SoC had a low incidence of organ damage accrual and no unexpected AEs. High-risk patients with pre-existing organ damage also had low accrual, suggesting a favorable effect on future damage development.

Objective: Rates of non-attendance for psychotherapy hinder the effective delivery of evidencebased treatments. Although many strategies have been developed to increase attendance, the effectiveness of these strategies has not been quantified. The aim of the present study was to undertake a meta-analysis of rigorously controlled studies to quantify the effects of interventions to promote psychotherapy attendance.Method: The inclusion criteria were that studies (1) concerned attendance at individual or group psychotherapy by adults, (2) used a randomised controlled trial design to test an attendance strategy, and (3) used an objective measure of attendance. Computerised literature searches and hand searching resulted in a total of 31 RCTs that involved 33 independent tests of strategies for reducing treatment refusal and premature termination (N = 4,422). Effect sizes from individual studies were meta-analysed and moderator analyses were conducted.Results: Interventions had a small-to-medium effect on attendance across studies (d + = .38).Interventions to reduce treatment refusal and premature termination were similarly effective (d + = .37 and .39, respectively). Choice of appointment time or therapist, motivational interventions, preparation for psychotherapy, informational interventions, attendance reminders, and case management were the most effective strategies. Diagnosis also moderated effect sizes; samples with a single diagnosis benefited more from attendance interventions than samples that had a variety of diagnoses.Conclusions: Interventions to increase attendance at adult psychotherapy are moderately effective.However, relatively few studies met the strict study inclusion criteria. Further methodologically sound and theoretically informed interventions geared at increasing attendance are required. META-ANALYSIS OF PSYCHOTHERAPY ATTENDANCE 3Interventions to Increase Attendance at Psychotherapy:A Meta-Analysis of Randomised Controlled Trials A substantial proportion of clinical time is wasted because of patient non-attendance at scheduled adult psychotherapy appointments (Pekarik, 1985). The financial costs of nonattendance are marked (Hicks & Hickman, 1995; Kleine, Stone, Hicks & Pritchard, 2003), with patients not receiving help (Joshi, Maisami & Coyle, 1986) and therapists losing confidence as a result (Sledge, Moras, Hartley & Levine, 1990). Service efficiency is impaired when nonattendance rates are high (Rusius, 1995). Garfield (1994) noted that some patients fail to attend at assessment and essentially reject treatment. Hampton-Robb, Qualls, and Compton (2003) estimated that such treatment refusal (TR) occurs for 40% of referrals, on average. Premature termination (PT) occurs when patients fail to complete agreed treatment contracts (i.e., they 'drop-out' of therapy). A meta-analysis of 123 studies reported a PT rate of 46.8% (Wierzbicki & Pekarik, 1993) across treatment modalities. High PT rates are troubling in light of evidence that PT is associated with poor clinical outcome (Barret...

IntroductionBelimumab, an anti-B-lymphocyte-stimulator antibody, is approved for the treatment of active, autoantibody-positive systemic lupus erythematosus (SLE). Rituximab, a B cell-depleting anti-CD20 antibody, remains in the SLE treatment armamentarium despite failed trials in lupus nephritis and extrarenal lupus. These biologics, which operate through complementary mechanisms, might result in an enhanced depletion of circulating and tissue-resident autoreactive B lymphocytes when administered together. Thus, belimumab and rituximab combination may be a highly effective treatment of SLE. This study aims to evaluate and compare the efficacy, safety and tolerability of subcutaneous (SC) belimumab and a single cycle of rituximab in patients with SLE with belimumab alone.Methods and analysisBLISS-BELIEVE is a three-arm, randomised, double-blind, placebo-controlled, 104-week superiority study. Two hundred adults with SLE will be randomised 1:2:1 to arm A, belimumab SC 200 mg/week for 52 weeks plus placebo at weeks 4 and 6; arm B, belimumab SC 200 mg/week for 52 weeks plus rituximab 1000 mg at weeks 4 and 6; arm C, belimumab SC 200 mg/week plus standard of care for 104 weeks. The 52-week treatment period (arms A and B) is followed by a 52-week observational phase. The primary efficacy endpoint is the proportion of patients with disease control (SLE Disease Activity Index (SLEDAI)−2K≤2, without immunosuppressants and with a prednisone-equivalent dose of ≤5 mg/day) at week 52. Major secondary efficacy endpoints are the proportion of patients in clinical remission (defined as SLEDAI-2K=0, without immunosuppressants and corticosteroids) at week 64, and the proportion of patients with disease control at week 104. Safety endpoints include the incidence of adverse events (AEs), serious AEs and AEs of special interest.Ethics and disseminationWithin 6 months of the study’s primary manuscript publication, anonymised individual participant data and study documents can be requested for further research fromwww.clinicalstudydatarequest.com.Trial registration numberNCT03312907; Pre-results.

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