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A Survey of Pediatric Rheumatologists to Determine Usage and Experience with Celebrex

A Survey of Pediatric Rheumatologists to Determine Usage and Experience with Celebrex. FDA Arthritis Advisory Committee November 29, 2006. Gloria C. Higgins, PhD, MD Associate Professor of Pediatrics The Ohio State University Division of Rheumatology Columbus Children’s Hospital.

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A Survey of Pediatric Rheumatologists to Determine Usage and Experience with Celebrex

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  1. A Survey of Pediatric Rheumatologists to Determine Usage and Experience with Celebrex FDA Arthritis Advisory Committee November 29, 2006 Gloria C. Higgins, PhD, MD Associate Professor of Pediatrics The Ohio State University Division of Rheumatology Columbus Children’s Hospital

  2. Methods: Independently generated and unsubsidized on-line survey using “Survey Monkey” service, conducted November ‘06 15 questions (drop-down or open-ended response) Anonymous or signed (responder’s choice) Responses solicited from US participants on Pediatric Rheumatology list-server, and sent individually by e-mail to all US pediatric rheumatologists in 2006 ACR directory Number of recipients unknown (> 150)

  3. Responders: Board-eligible Pediatric Rheumatologists 11 Board-certified Pediatric Rheumatologists 86 Non-board eligible or certified 6 Total 103 Years in practice: Mean 14.6 Range 0 – 43 (“0” years for 2 fellows) Total 1504 physician-years Distribution: 35 States, 1 US Territory

  4. Question: YesNo Cox-II important drugs for JRA? 95 8 Ever used Celebrex for JRA? 95 8 Advantages of COX-2 ? (>1 response possible) None 8 Fewer adverse effects 85 Easier dosing 27 Increased efficacy 5 Other (GI, hemostasis) 16

  5. Source of information? Chart review 2 Estimate 91 Number of patients treated with Celebrex? Responders = 94 0 - 9 patients 35 (37%) 10 - 25 35 (37%) 26 - 50 18 (19%) > 50 6 ( 6%) Total Celebrex exposures (estimated): 1118-2390 patients

  6. Average duration of Celebrex treatment? Responders = 82 < 1 mo 1 1 - 6 mo 17 7 - 12 mo 26 13 - 18 mo 15 > 18 mo 23 “Median” range 7- 18 mo

  7. When have you chosen Celebrex? Responders = 95 (> 1 answer possible) Preferred NSAID 2 If toxicity develops with other NSAID 67 If patient/family requests 14 Past success with other COX-2 25 After failure with 1 other NSAID 20 After failure with >1 other NSAID 48* Other: 23 Patients with GI disorders (ex; gastritis, IBD) thrombocytopenia, coagulation deficits, asthma. * Restrictions on insurance coverage cited

  8. Have you seen significant adverse effects or toxicities with Celebrex ? Responders = 95 No 83 (87%) Yes 12 (13%) Do the adverse effects or toxicities with Celebrex differ from other NSAIDs ? Responders = 75 No 63 (84%) Yes 12 (16%) * *Less GI toxicity, less bruising.

  9. Have you seen any vascular thromboses or cardiovascular toxicities in JRA patients treated… With traditional NSAIDS ? Responders = 95 No 94 Yes 1 * *1 patient with thoracic outlet syndrome developed a deep vein thrombosis With Celebrex ? Responders = 94 No 94 Yes 0

  10. Summary NSAIDs are frequently used in the treatment of JRA. The results of this practice-based survey indicate: (1) COX-2 inhibitory drugs are perceived by most pediatric rheumatologists as important for the treatment of JRA. Celebrex is used mainly in cases of treatment failure, or toxicity with other NSAIDs. (2) Celebrex is typically used for relatively short periods for treatment of JRA. (3) Celebrex appears to have similar adverse effects or toxicity in children as other NSAIDS, and may be associated with less GI toxicity and bruising.

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