PMID- 34791634 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220304 IS - 2193-8237 (Print) IS - 2193-651X (Electronic) VI - 11 IP - 1 DP - 2022 Mar TI - Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. PG - 289-302 LID - 10.1007/s40122-021-00335-z [doi] AB - INTRODUCTION: A phase 3 randomized controlled study comparing triamcinolone acetonide extended-release (TA-ER) to conventional TA crystalline suspension (TAcs) reported variable efficacy results. Enrollment criteria may have contributed to this discrepancy, as moderate-to-severe average daily pain (ADP) was required at baseline, whereas no limitations were placed on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) pain severity. We conducted a post hoc sensitivity analysis to compare treatment effects in patients reporting moderate-to-severe osteoarthritis (OA) pain on both scales. METHODS: Participants > 40 years old with symptomatic knee OA were randomly assigned to a single intra-articular injection of TA-ER 32 mg, TAcs 40 mg, or saline-placebo and followed for 24 weeks. Patient-reported ADP, WOMAC-A, rescue medication usage, and adverse events (AEs) were assessed. Participants who reported moderate-to-severe OA pain at baseline using both instruments (ADP >/= 5 to /= 2, maximum 4) were categorized as "concordant" pain reporters; patients with baseline moderate-to-severe OA on ADP only were termed "discordant" pain reporters. RESULTS: Two-hundred-ninety-two concordant pain reporters of 484 total subjects received TA-ER 32 mg (n = 95), TAcs 40 mg (n = 100), or saline-placebo (n = 97). Baseline characteristics and AE profiles of the concordant and discordant pain responders were consistent with the full analysis population. Among concordant pain reporters, TA-ER significantly (p < 0.05) improved ADP scores vs. TAcs (weeks 5-19; area-under-the-effect [AUE](weeks1-12); AUE(weeks1-24)) and saline-placebo (weeks 1-20; AUE(weeks1-12); AUE(weeks1-24)). At week 12, a higher proportion reported no knee pain (ADP = 0) with TA-ER (~ 28%) vs. TAcs (~ 8%). TA-ER significantly improved WOMAC-A vs. TAcs at weeks 4, 8, and 12, with significant reduction in rescue medication usage observed with TA-ER from weeks 2 to 20 vs. TAcs. CONCLUSIONS: In patients reporting moderate-to-severe knee OA pain at baseline based on concordant ADP and WOMAC-A scores, TA-ER provided statistically significant pain relief for >/= 12 weeks compared with conventional TAcs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02357459. CI - (c) 2021. The Author(s). FAU - Ross, Edgar AU - Ross E AD - Brigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA. elross@bwh.harvard.edu. FAU - Katz, Nathaniel P AU - Katz NP AD - Analgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA. FAU - Conaghan, Philip G AU - Conaghan PG AD - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, LS7 4SA, UK. FAU - Kivitz, Alan AU - Kivitz A AD - Altoona Center for Clinical Research, 178 Meadowbrook Lane, P.O. Box 1018, Duncansville, PA, 16635, USA. FAU - Turk, Dennis C AU - Turk DC AD - Washington Medicine, Box 356540, 1949 NE Pacific Street, Seattle, WA, 98195, USA. FAU - Spitzer, Andrew I AU - Spitzer AI AD - Department of Orthopaedic Surgery, Cedars-Sinai Medical Center, 444 S. San Vicente Blvd #603, Los Angeles, CA, 90048, USA. FAU - Jones, Deryk G AU - Jones DG AD - Ochsner Sports Medicine Institute, 1221 S. Clearview Pkwy, Harahan, LA, 70121, USA. FAU - Lanier, Ryan K AU - Lanier RK AD - Analgesic Solutions, 321 Commonwealth Rd, Wayland, MA, 01778, USA. FAU - Cinar, Amy AU - Cinar A AD - Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA. FAU - Lufkin, Joelle AU - Lufkin J AD - Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA. FAU - Kelley, Scott D AU - Kelley SD AD - Flexion Therapeutics Inc., 10 Mall Road, Suite 301, Burlington, MA, 01803, USA. LA - eng SI - ClinicalTrials.gov/NCT02357459 PT - Journal Article DEP - 20211117 PL - New Zealand TA - Pain Ther JT - Pain and therapy JID - 101634491 PMC - PMC8861226 OAB - Osteoarthritis is a chronic condition that greatly impacts patients. Pain is the most common symptom of osteoarthritis. Clinical trials evaluating the effects of new drugs to treat osteoarthritis pain frequently use scales to rate overall pain following treatment. Patients may rate their pain using a number that best describes their pain, with the lowest number typically meaning "no pain," and the highest number typically meaning "pain as bad as you can imagine." Other rating scales may be used to rate pain in situations commonly associated with osteoarthritis.Results from a large clinical trial demonstrated that injection of an extended-release steroid significantly reduced pain compared with a conventional steroid injection on only one of the two pain-reporting scales used in the trial. A closer look found that some patients reported their pain differently on the two rating scales at the start of the trial, with some reporting moderate-to-severe pain using one questionnaire and mild pain using the other. Here, we focused on those patients who reported having moderate-to-severe osteoarthritis knee pain on both pain scales at the start and found that the pain relief benefit associated with the extended-release steroid injection was greatly improved compared with the conventional steroid injection with both measures. Patients receiving the extended-release steroid injection also decreased their use of rescue medication for pain relief. OABL- eng OTO - NOTNLM OT - Corticosteroid OT - Intra-articular OT - Knee osteoarthritis OT - Pain OT - Triamcinolone acetonide extended-release EDAT- 2021/11/19 06:00 MHDA- 2021/11/19 06:01 PMCR- 2021/11/17 CRDT- 2021/11/18 07:42 PHST- 2021/08/14 00:00 [received] PHST- 2021/10/20 00:00 [accepted] PHST- 2021/11/19 06:00 [pubmed] PHST- 2021/11/19 06:01 [medline] PHST- 2021/11/18 07:42 [entrez] PHST- 2021/11/17 00:00 [pmc-release] AID - 10.1007/s40122-021-00335-z [pii] AID - 335 [pii] AID - 10.1007/s40122-021-00335-z [doi] PST - ppublish SO - Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.