What happens next?: a claims database study of second-line pharmacotherapy in patients with major depressive disorder (MDD) who initiate selective serotonin reuptake inhibitor (SSRI) treatment

BACKGROUND: The objective of this research was to examine treatment patterns and health-care costs associated with second-step pharmacotherapy in patients with major depressive disorder (MDD) who initiated monotherapy with a selective serotonin reuptake inhibitor (SSRI) in 2010. METHODS: This claims database study analyzed patients diagnosed with MDD who were prescribed a monotherapy SSRI, with the first prescription identified as the index date. Patients were required to be ≥18 years old, to have continuous insurance coverage from 1 year prior (pre-index) through 1 year post (post-index) from the index date, and to have not received an antidepressant in the pre-index period. The analyses are descriptive of the patient characteristics, initial SSRI prescribed, most commonly prescribed second-step therapies, and annualized health-care costs. RESULTS: The identified patients (N = 5,012) were predominantly female (65.2%) with a mean age of 41.9 years. The most frequent index SSRIs were citalopram (30.1%) and sertraline (27.5%), and 52.9% of patients were prescribed a second-step pharmacotherapy during the post-index period. Add-on therapy occurred twice more frequently than switching treatments, with either anxiolytics (40.2%) or antidepressants (37.1%) as the most common classes of add-on pharmacological therapies. Patients who added a second medication or switched therapies had higher annualized medical costs compared with patients who continued their index SSRI or discontinued treatment. CONCLUSIONS: For patients who were initially treated with an SSRI therapy, approximately half were prescribed a second-step treatment. In this comprehensive claims analysis, many of these patients experienced the addition of second medication, rather than switching to a new therapy. Given the type of medications used, it is possible that second-step interventions were targeted toward resolution of residual symptoms; however, this work is limited by the use of claims data without information on dosing or clinical symptoms, side effects, or response. Findings from this study set the expectation that physicians and patients will most likely need to partner for additional interventions in order to achieve remission

The functional impact of subsyndromal depressive symptoms in bipolar disorder: Data from STEP-BD

Background This report describes baseline characteristics and functional outcomes of subjects who have prospectively observed subsyndromal symptoms after a major depressive episode (MDE). Methods All subjects were participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). We identified subjects with at least 2 years of observation whose prior or current episode was a MDE, and who were in a stable clinical state of either recovered (no more than 2 moderate symptoms for at least 8 weeks), a MDE by DSM IV criteria, or with continued subsyndromal symptoms. The subsyndromal group was defined a priori as 3 or more moderate affective symptoms but without meeting diagnostic criteria for major depression. Results The final cohort included 1094 recovered, 112 subsyndromal, and 310 individuals in a MDE. The average time spent in each clinical status ranged from 120 to 132 days. The subsyndromal group was most similar to those in a MDE, differing only on the intensity of depressive symptoms and the number of work days missed due to ongoing symptoms. Reported sadness, inability to feel and lassitude were each associated with multiple measures of impairment. Limitations This study is limited by the cross sectional approach to defining outcomes. Conclusions These findings are consistent with studies in unipolar major depression that indicate that functional impairment observed in the context of subsyndromal depressive symptoms is comparable to that of a full episode. This work underscores the need to include subsyndromal symptoms in study outcomes and to target full remission in clinical practice.Psycholog

Impact of non-remission of depression on costs and resource utilization: from the COmorbidities and symptoms of DEpression (CODE) study

<p>To determine the economic impact of sustained non-remission of depression on the total annual all-cause healthcare costs of patients with a history of depression.</p> <p>Adults with ≥2 claims with depression diagnosis codes from the HealthCore Integrated Research Database were invited to participate in this retrospective/prospective fixed-cohort repeated-measures study. Patients with scores >5 at initial survey and 6 month assessment on the Quick Inventory of Depressive Symptomatology (QIDS-SR) were considered to be in ‘sustained non-remission’, while those with scores ≤5 at both assessments were considered to be in ‘sustained remission’. Patients also completed self-report instruments to assess pain, fatigue, anxiety, sleep difficulty, and other health and wellness domains. Survey data were linked to patient claims (12 month pre- and post-initial-survey periods). After adjusting for demographic and clinical characteristics using propensity scores, post-survey costs and resource utilization were compared between remission and non-remission groups using non-parametric bootstrapping methods.</p> <p>Of the 640 patients who met inclusion criteria, 140 (21.9%) were in sustained remission and 348 (54.5%) never achieved remission. Using propensity-score adjusted costs, sustained non-remission of depression was associated with higher annual healthcare expenditures of >$2300 per patient ($14,627 vs. $12,313, <i>p</i> = 0.0010) compared to remitted patients. Higher costs were associated with greater resource utilization and increased medication use. Non-remitters were prescribed more medications than remitters, including antidepressants and second-generation antipsychotics. Although length of antidepressant exposure over 12 months was similar, remitters were more likely to be adherent to antidepressants. Non-remission was associated with anxiety, pain, fatigue, sleep disruption, diabetes, anemia, obesity, and heavy drinking.</p> <p>Failing to achieve remission of depression was associated with increased costs and greater resource utilization. Clinicians should strive to achieve sustained remission in patients with depression. Study limitations included reliance on claims data for initial identification of cohort and high rate of attrition in the analytic sample.</p

Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3)

<p><b>Background:</b> Scalp is a frequently affected and difficult-to-treat area in psoriasis patients.</p> <p><b>Objective:</b> We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI).</p> <p><b>Methods:</b> In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (<i>N</i> = 1296), UNCOVER-2 (<i>N</i> = 1224) and UNCOVER-3 (<i>N</i> = 1346) were randomized to subcutaneous 80 mg ixekizumab every two weeks (Q2W) or every four weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg bi-weekly etanercept through Week 12. Patients entering the open-label long-term extension (LTE) (UNCOVER-3) received ixekizumab Q4W; UNCOVER-1 and UNCOVER-2 included a blinded maintenance period in which static physician global assessment (sPGA) 0/1 responders were re-randomized to placebo, ixekizumab Q4W, or 80 mg ixekizumab every 12 weeks (Q12W) through Week 60.</p> <p><b>Results:</b> In patients with moderate-to-severe psoriasis with baseline scalp involvement, PSSI 90 and 100 were achieved at Week 12 in higher percentages of patients treated with ixekizumab Q2W (81.7% and 74.6%) or ixekizumab Q4W (75.6% and 68.9%) compared with patients treated with placebo (7.6% and 6.7%; <i>p</i> < .001 each ixekizumab arm versus placebo) or etanercept (55.5% and 48.1%; <i>p</i> < .001 each ixekizumab arm versus etanercept). These outcomes were maintained through Week 60 of the maintenance (UNCOVER-1 and UNCOVER-2) and LTE (UNCOVER-3) period in patients who continued on ixekizumab Q4W.</p> <p><b>Conclusion:</b> Ixekizumab was efficacious in treating scalp psoriasis in patients with moderate-to-severe psoriasis, with most patients achieving complete or near-complete resolution of scalp psoriasis and maintaining this response over 60 weeks.</p