TBD Meeting (5366-18)

WASHINGTON – Present infections make patients more likely to develop primary Sjögren’s syndrome, according to a study presented at an International Symposium on Sjögren’s Syndrome.

“We observed a consistent association between infections and the subsequent development of primary Sjögren’s syndrome,” said Johannes Mofors of the department of medicine at the Karolinska University Hospital, Stockholm, in his presentation. “Infections of certain anatomical sites have different associations to Sjögren’s.”

With risk measurements primarily reliant on detecting the presence of MHC genes, this knowledge could be helpful in identifying at-risk patients and give physicians the chance to act before the syndrome emerges, according to Mr. Mofors.

Investigators conducted a retrospective, multicenter, controlled cohort study of 9,993 Swedish individuals from the country’s national patient registry to observe the association between infections and Sjögren’s.

Patients were an average age of 55 years, with either an SSA or SSB infection, with an average observational period of 16 years before diagnosis.

Of the patients with Sjögren’s disease, 21% reported one or more infections prior to diagnosis, compared with 12% among the control group.

When assessing patients by their type of infection, Mr. Mofors and his colleagues found the likelihood of developing Sjögren’s varied depending on which infection was present.

 

“We looked at respiratory infections, with the SSA/Ro-, SSB/Ro-positive patients having a stronger association than the corresponding rate of SSA-, SSB-negative patients,” explained Mr. Mofors. “Interestingly, as we looked at patients with skin infections, we observed an association with the SSA-, SSB-positive patients having a stronger association than the negative patients.”

Investigators also tested gastrointestinal infections, but found no clear association to Sjögren’s.

Presence of more than one infection also appeared to increased disposition of patients to Sjögren’s syndrome, although it depended on the type of infection, Mr. Mofors said at the meeting, which was sponsored by Johns Hopkins University and the National Institutes of Health.

Patients with multiple respiratory infections showed a stronger association to Sjögren’s, patients with SSA- or SSB-positive infection displaying even stronger prevalence, and patients with skin infections showed a dose-response pattern.

 

Patients with SSA or SSB pattern showed no significant association.

It is possible, said Mr. Mofors, that patients became more susceptible to infection as their Sjögren’s manifested, so investigators extended the omission period of their study from 3 to 7 years.

“As the omission period was extended, in the aggregated group of cases we saw a less prominent association; however, for the respiratory infections the change in relationship was insignificant,” said Mr. Mofors.

For SSA- and SSB-negative patients, the association between infections and predisposition to Sögren’s was not significant when the omission period was extended.

Mr. Mofors reported no relevant financial disclosures.

[email protected]

WASHINGTON – Present infections make patients more likely to develop primary Sjögren’s syndrome, according to a study presented at an International Symposium on Sjögren’s Syndrome.

“We observed a consistent association between infections and the subsequent development of primary Sjögren’s syndrome,” said Johannes Mofors of the department of medicine at the Karolinska University Hospital, Stockholm, in his presentation. “Infections of certain anatomical sites have different associations to Sjögren’s.”

With risk measurements primarily reliant on detecting the presence of MHC genes, this knowledge could be helpful in identifying at-risk patients and give physicians the chance to act before the syndrome emerges, according to Mr. Mofors.

Investigators conducted a retrospective, multicenter, controlled cohort study of 9,993 Swedish individuals from the country’s national patient registry to observe the association between infections and Sjögren’s.

Patients were an average age of 55 years, with either an SSA or SSB infection, with an average observational period of 16 years before diagnosis.

Of the patients with Sjögren’s disease, 21% reported one or more infections prior to diagnosis, compared with 12% among the control group.

When assessing patients by their type of infection, Mr. Mofors and his colleagues found the likelihood of developing Sjögren’s varied depending on which infection was present.

 

“We looked at respiratory infections, with the SSA/Ro-, SSB/Ro-positive patients having a stronger association than the corresponding rate of SSA-, SSB-negative patients,” explained Mr. Mofors. “Interestingly, as we looked at patients with skin infections, we observed an association with the SSA-, SSB-positive patients having a stronger association than the negative patients.”

Investigators also tested gastrointestinal infections, but found no clear association to Sjögren’s.

Presence of more than one infection also appeared to increased disposition of patients to Sjögren’s syndrome, although it depended on the type of infection, Mr. Mofors said at the meeting, which was sponsored by Johns Hopkins University and the National Institutes of Health.

Patients with multiple respiratory infections showed a stronger association to Sjögren’s, patients with SSA- or SSB-positive infection displaying even stronger prevalence, and patients with skin infections showed a dose-response pattern.

 

Patients with SSA or SSB pattern showed no significant association.

It is possible, said Mr. Mofors, that patients became more susceptible to infection as their Sjögren’s manifested, so investigators extended the omission period of their study from 3 to 7 years.

“As the omission period was extended, in the aggregated group of cases we saw a less prominent association; however, for the respiratory infections the change in relationship was insignificant,” said Mr. Mofors.

For SSA- and SSB-negative patients, the association between infections and predisposition to Sögren’s was not significant when the omission period was extended.

Mr. Mofors reported no relevant financial disclosures.

[email protected]

WASHINGTON – Present infections make patients more likely to develop primary Sjögren’s syndrome, according to a study presented at an International Symposium on Sjögren’s Syndrome.

“We observed a consistent association between infections and the subsequent development of primary Sjögren’s syndrome,” said Johannes Mofors of the department of medicine at the Karolinska University Hospital, Stockholm, in his presentation. “Infections of certain anatomical sites have different associations to Sjögren’s.”

With risk measurements primarily reliant on detecting the presence of MHC genes, this knowledge could be helpful in identifying at-risk patients and give physicians the chance to act before the syndrome emerges, according to Mr. Mofors.

Investigators conducted a retrospective, multicenter, controlled cohort study of 9,993 Swedish individuals from the country’s national patient registry to observe the association between infections and Sjögren’s.

Patients were an average age of 55 years, with either an SSA or SSB infection, with an average observational period of 16 years before diagnosis.

Of the patients with Sjögren’s disease, 21% reported one or more infections prior to diagnosis, compared with 12% among the control group.

When assessing patients by their type of infection, Mr. Mofors and his colleagues found the likelihood of developing Sjögren’s varied depending on which infection was present.

 

“We looked at respiratory infections, with the SSA/Ro-, SSB/Ro-positive patients having a stronger association than the corresponding rate of SSA-, SSB-negative patients,” explained Mr. Mofors. “Interestingly, as we looked at patients with skin infections, we observed an association with the SSA-, SSB-positive patients having a stronger association than the negative patients.”

Investigators also tested gastrointestinal infections, but found no clear association to Sjögren’s.

Presence of more than one infection also appeared to increased disposition of patients to Sjögren’s syndrome, although it depended on the type of infection, Mr. Mofors said at the meeting, which was sponsored by Johns Hopkins University and the National Institutes of Health.

Patients with multiple respiratory infections showed a stronger association to Sjögren’s, patients with SSA- or SSB-positive infection displaying even stronger prevalence, and patients with skin infections showed a dose-response pattern.

 

Patients with SSA or SSB pattern showed no significant association.

It is possible, said Mr. Mofors, that patients became more susceptible to infection as their Sjögren’s manifested, so investigators extended the omission period of their study from 3 to 7 years.

“As the omission period was extended, in the aggregated group of cases we saw a less prominent association; however, for the respiratory infections the change in relationship was insignificant,” said Mr. Mofors.

For SSA- and SSB-negative patients, the association between infections and predisposition to Sögren’s was not significant when the omission period was extended.

Mr. Mofors reported no relevant financial disclosures.

[email protected]

WASHINGTON – Over one-third of 28 outcomes identified to be important to Sjogren’s patients with dry eye are not commonly found in existing research, according to a study presented at the International Symposium on Sjogren’s Syndrome.

With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.

“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.

Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.

The majority of the patients were white American women, aged 50 years and older.

To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.

The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.

 

When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.

Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.

When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.

With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.

 

“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.

Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.

[email protected]

SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.

WASHINGTON – Over one-third of 28 outcomes identified to be important to Sjogren’s patients with dry eye are not commonly found in existing research, according to a study presented at the International Symposium on Sjogren’s Syndrome.

With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.

“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.

Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.

The majority of the patients were white American women, aged 50 years and older.

To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.

The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.

 

When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.

Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.

When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.

With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.

 

“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.

Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.

[email protected]

SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.

WASHINGTON – Over one-third of 28 outcomes identified to be important to Sjogren’s patients with dry eye are not commonly found in existing research, according to a study presented at the International Symposium on Sjogren’s Syndrome.

With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.

“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.

Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.

The majority of the patients were white American women, aged 50 years and older.

To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.

The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.

 

When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.

Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.

When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.

With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.

 

“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.

Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.

[email protected]

SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.