Rescue analgesic Medication Use by Patients Treated With Triamcinolone Acetonide Extended-Release for Knee Osteoarthritis Pain: Pooled Analysis of Three Phase 2/3 Randomized Clinical Trials

Introduction In clinical trials for knee osteoarthritis (OAK), rescue medication is commonly provided to manage uncontrolled index-knee pain. The impact of treatment on rescue medication utilization provides important information on the robustness of analgesic effect. In randomized controlled OAK trials (NCT01487161, NCT02116972, NCT02357459), intra-articular (IA) triamcinolone acetonide extended-release (TA-ER) demonstrated substantial, prolonged analgesia versus saline-placebo and TA crystalline solution (TAcs) as assessed by patient-reported pain scales. This pooled analysis assessed the impact of TA-ER on rescue medication use. Methods Patients (N = 798) with OAK (American College of Rheumatology criteria; Kellgren–Lawrence grade 2/3) and baseline average daily pain intensity score ≥ 5 to ≤ 9 (0–10 numeric rating scale) received a single IA injection of TA-ER (N = 324), saline-placebo (N = 262), or TAcs (N = 212). Acetaminophen/paracetamol tablets were provided to treat uncontrolled pain (knee or otherwise). Rescue medication consumption was monitored through a daily diary; pill counts were confirmed at the clinical site. Differences in rescue medication use were measured by least-squares mean (LSM) differences, number of rescue medication tablets used per day, and in area under the effect (AUE) curves of rescue medication tablets used per week. Results The overall number of rescue medication tablets used per day through week 24 was significantly less (p ≤ 0.05) for TA-ER versus saline-placebo (LSM difference, − 0.43) and TAcs (− 0.24). Rescue medication use was significantly (p ≤ 0.05) lower following TA-ER versus saline-placebo across weeks 1–12 (AUEweeks1–12; LSM difference, − 24.5) and weeks 1–24 (AUEweeks1–24; − 51.6) and versus TAcs across weeks 1–12 (AUEweeks1–12; − 21.1). Conclusions In patients with painful OAK, reduced rescue medication use may be a potential benefit of TA-ER and further supports its analgesic efficacy. Additional research is needed to assess whether TA-ER impacts the use of other common oral analgesics (nonsteroidal anti-inflammatory drugs, opioids) for patients with OAK

Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: Results of the randomized, placebocontrolled PALACE 4 trial

Objectives. The PALACE 4 trial evaluated apremilast monotherapy in patients with active PsA who were DMARD-naive. Methods. Eligible patients were randomized (1:1:1) to placebo, apremilast 20mg twice a day or apremilast 30mg twice a day. At week 16 or 24, placebo patients were rerandomized to apremilast. Double-blind apremilast treatment continued to week 52, with extension up to 4 years. The primary endpoint was the proportion of patients achieving ≥20% improvement in ACR response criteria (ACR20) at week 16; secondary endpoints included the mean change in the HAQ Disability Index (HAQ-DI) score at week 16. Results. A total of 527 patients with mean disease duration of 3.4 years and high disease activity were randomized and received treatment. More apremilast patients achieved ACR20 response at week 16 [placebo, 15.9%; 20 mg, 28.0% (P = 0.0062); 30 mg, 30.7% (P = 0.0010)]. The mean HAQ-DI improvements were -0.17 (20 mg; P = 0.0008) and -0.21 (30 mg; P<0.0001) vs 0.03 (placebo). Both apremilast doses showed significant ACR50 responses vs placebo at week 16 and improvements in secondary efficacy measures (swollen/tender joint counts) and psoriasis assessments, with sustained improvements through week 52. Common adverse events (AEs) over 52 weeks were diarrhoea, nausea, headache and upper respiratory tract infection; most events were mild or moderate. Serious AEs and AEs leading to discontinuation were comparable between groups. Laboratory abnormalities were infrequent and transient. Conclusions. In DMARD-naive patients, apremilast monotherapy improved PsA signs/symptoms over 52 weeks and was generally well tolerated

SAT0548 Plasma CGRP concentrations were not associated with patient OA symptoms or response to galcanezumab, a monoclonal antibody against CGRP

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Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

Joseph Ross and colleagues examine publication rates of clinical trials and find low rates of publication even following registration in Clinicaltrials.gov

Evolving treatment paradigms for rheumatoid arthritis: Translating comprehensive patient evaluations into personalized therapy

This CME/CE-accredited CME Snapshot™ series of educational videos has been created for rheumatologists and other clinicians involved in treating patients with rheumatoid arthritis (RA). During each 15-minute activity, two expert rheumatologists focus on a specific aspect of long-term RA management, including practical advice on implementing international treat-to-target guidelines as well as the mechanistic profiles and clinical evidence for therapies designed to inhibit signaling via interleukin-6 (IL-6) or members of the Janus kinase (JAK) family of enzymes. Some of the modules also include 3D-animated elements to illustrate the relationships between the heterogeneous pathophysiologic mechanisms underlying RA and certain targeted biologic or synthetic disease-modifying treatment options. (Online access: https://rasnapshotcme.elsevierresource.com/)

Simulating clinical trial visits yields patient insights into study design and recruitment

S Sam Lim,1 Alan J Kivitz,2 Doug McKinnell,3 M Edward Pierson,4 Faye S O&rsquo;Brien4 1Division of Rheumatology, Department of Medicine, Emory University, Atlanta, GA, USA; 2Altoona Center for Clinical Research, Altoona, PA, USA; 3Deloitte Life Sciences Advisory, Basel, Switzerland; 4Clinical Operations, Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA Purpose: We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.Patients and methods: Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.Results: The Atlanta study involved 6 African-American patients (5 female) aged 27&ndash;60&nbsp;years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32&ndash;75&nbsp;years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials.Conclusion: Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy. Keywords: systemic lupus erythematosus, lupus nephritis, clinical trial simulation, patient recruitment, patient retentio