New Restasis study

[Steve]

Crossposted this URL here too.

http://www.medscape.com/medline/abstract/17070588

Study shows a (small but real) chance of remission of symptoms using Restasis.

Article is available only to members, so here's a quote:

Ophthalmology
January 2007 ( Volume 114, Number 1 )



Long-term Resolution of Chronic Dry Eye Symptoms and Signs After Topical Cyclosporine Treatment
Wilson SE, Perry HD
Ophthalmology. 2007;114(1)

Topical cyclosporine A is a proven treatment for dry eye syndrome. Most patients have improvement of symptoms after several months of treatment. In those who do benefit from treatment, most notice return of symptoms when cyclosporine treatment is stopped. However, a subset of patients who discontinue therapy after 6 months of continuous use finds complete resolution of symptoms.

The authors presented 8 patients from 2 practices who were "cured" of dry eye symptoms with topical cyclosporine. Between the 2 practices, there were 252 patients treated for dry eye; the 5 patients from one practice represented 3.9% of patients treated for dry eye, while the 3 patients in the other practice represented 1.5%. Seven out of 8 were female. Average age was 45 years (range, 32-58). One patient had a history of Sjögren's syndrome, and 2 had thyroid autoimmune disease. Since cessation of treatment, the average symptom-free time period was 21 months (range, 17-29 months). Average duration of treatment prior to cessation of therapy was 17 months (range, 6-72 months).

This report demonstrated that some patients, albeit a small percentage, can have complete resolution of symptoms after 6 months of therapy with topical cyclosporine. If a patient attains complete resolution of symptoms and has been treated for 6 months or longer, the authors recommended considering a trial off the medication.

[Pinky]

Restasis and remission

Hi Steve,
Thanks for posting this info. I belong to a rosacea board and several posters with ocular rosacea had resolution of symptoms after six months of treatment with Restasis. One woman's doctor had her stay on the med for one year just to be on the safe side. A year after going off the med she was still symptom free.

I have sudden onset DES and MGD. I have been on Restasis for three months now. It has helped quite a bit. I phoned a rep at Allergan to see if I can expect max. improvement at three or six months because I keep reading different time frames. She didn't really give me an answer, I guess it was more or less "everyone is different." But she kept emphasizing that I would have to be on the drops for the rest of my life; that I would lose all the improvement I had gained if I went off the drops. I told her that I heard of several anecdotal reports of people being in remission after going off the drops. She sure wasn't too interested in hearing about that, and basically had no comment.

[robinzb]

Hi Steve,
Thanks for posting this info. I belong to a rosacea board and several posters with ocular rosacea had resolution of symptoms after six months of treatment with Restasis. One woman's doctor had her stay on the med for one year just to be on the safe side. A year after going off the med she was still symptom free.

I have sudden onset DES and MGD. I have been on Restasis for three months now. It has helped quite a bit. I phoned a rep at Allergan to see if I can expect max. improvement at three or six months because I keep reading different time frames. She didn't really give me an answer, I guess it was more or less "everyone is different." But she kept emphasizing that I would have to be on the drops for the rest of my life; that I would lose all the improvement I had gained if I went off the drops. I told her that I heard of several anecdotal reports of people being in remission after going off the drops. She sure wasn't too interested in hearing about that, and basically had no comment.

well, of course she didnt have any comments. if ppl could stop using this drug, then allergen would have massive loss of profit

[kitty]

Crossposted this URL here too.

http://www.medscape.com/medline/abstract/17070588

Study shows a (small but real) chance of remission of symptoms using Restasis.

Article is available only to members, so here's a quote:

Ophthalmology
January 2007 ( Volume 114, Number 1 )



Long-term Resolution of Chronic Dry Eye Symptoms and Signs After Topical Cyclosporine Treatment
Wilson SE, Perry HD
Ophthalmology. 2007;114(1)

Topical cyclosporine A is a proven treatment for dry eye syndrome. Most patients have improvement of symptoms after several months of treatment. In those who do benefit from treatment, most notice return of symptoms when cyclosporine treatment is stopped. However, a subset of patients who discontinue therapy after 6 months of continuous use finds complete resolution of symptoms.

The authors presented 8 patients from 2 practices who were "cured" of dry eye symptoms with topical cyclosporine. Between the 2 practices, there were 252 patients treated for dry eye; the 5 patients from one practice represented 3.9% of patients treated for dry eye, while the 3 patients in the other practice represented 1.5%. Seven out of 8 were female. Average age was 45 years (range, 32-58). One patient had a history of Sjögren's syndrome, and 2 had thyroid autoimmune disease. Since cessation of treatment, the average symptom-free time period was 21 months (range, 17-29 months). Average duration of treatment prior to cessation of therapy was 17 months (range, 6-72 months).

This report demonstrated that some patients, albeit a small percentage, can have complete resolution of symptoms after 6 months of therapy with topical cyclosporine. If a patient attains complete resolution of symptoms and has been treated for 6 months or longer, the authors recommended considering a trial off the medication.

This is interesting. Given the average age and gender of those who saw this miracle, (45 y.o. females) I have to question if there were reasons other than the Restasis for the cure, such as hormonal reasons.

[Steve]

between 1 and 4%

I think the lady on the phone would have been right to emphasize what she did even if she were completely up on this study, and even if the company didn't have a financial interest in selling you the drugs.

Telling someone over the phone about a lucky miracle that has been shown in ONE study to have a rate of success between 1 and 4% would be a disservice and would just be raising false hopes in 96 to 99% of people, don't you think?

[Rebecca Petris]

A letter to the editor.

A letter to the editor about this Restasis study was published in this month's Ophthalmology. Emphasis mine.

Dear Editor:

I read with interest the recent article by Wilson and Perry describing 8 patients with dry eye syndrome who were cured "of symptoms and signs" after treatment with topical cyclosporine 0.05% (Restasis, Allergan Inc., Irvine, CA). In their Tables 2 and 3, the authors report objective findings (tear breakup time, Schirmer testing, vital dye staining) before and after treatment; these data support their conclusion that examination findings of dry eye resolved.

Their Table 1 gives patient demographics, including specific pretreatment symptoms. We are not given primary data regarding posttreatment symptoms or lack thereof; the authors declare in narrative that all subjects were symptom-free. However, clinicians know that patients who are miserable will arrive with a symptom list in hand; patients who are much improved and are satisfied with their current treatment may report "all better", which means that they do not feel the need to complain about low-grade and infrequent symptoms.

In general, journal editors and reviewers should require better science in the measurement of dry eye symptoms, now that simple, efficient, validated patient questionnaires are available (e.g. the Ocular Surface Disease Index, developed by Allergan). Despite the authors' national recognition as experts in the field of dry eye, readers are under no obligation to take their word for it that these unusual patients were entirely without symptoms after cyclosporine treatment. Further, the greater the perceived potential for investigator bias, the more carefully authors must defend their neutrality through excellent methodology in data collection and analysis.

My high school English teacher railed against the phrase very unique, as an object or event is either unique or it is not. Similarly, a patient is either improved or cured, and mostly improved is not cured. Cure is a potent word, and I do not believe the authors have proved their statement that topical cyclosporine cures symptoms of dry eye syndrome in a subgroup of patients.

Sandra M. Brown, MD
Concord, North Carolina

[Rebecca Petris]

p.s. I did a little editorializing about this on my blog this morning.

[crispen_2000]

Restasis - Cured!!!!

Hi,

I just wanted to let everyone know that I was on restasis for nine months and it basically CURED me. I no longer have to use drops. I have been able to get on with my life - I am so pleased, to say the least. I can now drive with the window down and read alll I want....try restasis. Yolu have nothing to loose, but approach it knowing that it doesn't work for everyone.

All the best and good luck....

Trevor

[IanJ]

Trevor,

Very interesting!

What were your symtoms before Restasis......was it lacrimal gland dysfunction, evaporative, etc etc..........how did it manifest itself?

Ian.