# Presentation: 816220

## 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**

## 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)**

**Notes:**
Add dates of survey- this is important- it is very recent data. Did you want to credit Harry Gewanter somewhere???

## Board-certified Pediatric Rheumatologists 	  86

**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**

## Question:					Yes	No

**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**

## Source of information?

**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****	****	**

## Average duration of Celebrex treatment?

**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**

## When have you chosen Celebrex?

**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

**Notes:**
You could combine failure with 2- 4 and failure with > 4 NSAIDs.  So, would be failure with > 1 NSAID and add both to = 48

## Have you seen significant adverse effects or toxicities

**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.****	****	****	**

## Have you seen any vascular thromboses or

**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**

**Notes:**
What is OCs? What is PEs? Spell out if possible. What is relationship with risk factors? This one seems problematic...

## Summary

**Summary**

**	****   ****(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.**

**NSAIDs are frequently used in the treatment of JRA.**

**The results of this practice-based survey indicate:**