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Arthritis Pain Varies With Barometric Pressure and Outside Temperature
SAN ANTONIO — Physicians tend to be skeptical of arthritis patients' claims that they can feel bad weather coming on, but maybe they shouldn't be, Timothy E. McAlindon, M.D., said at the annual meeting of the American College of Rheumatology.
Findings from a study by Dr. McAlindon and his colleagues at Tufts-New England Medical Center, Boston, suggest that persons with knee osteoarthritis do have greater pain when there are changes in barometric pressure.
Previous studies probably have failed to document this phenomenon because they have not been able to be as precise in their weather measurements as this study, surmised Dr. McAlindon, chief of the division of rheumatology at Tufts.
The investigators collected data on 205 patients who took part in a 3-month trial of glucosamine that tracked participants using the Internet, which enabled them to be from a variety of regions within the U.S. The subjects lived in 41 different states; almost all of them experienced very different weather.
During the initial study, which found no positive effect from glucosamine, subjects completed Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain questionnaires every 2 weeks.
Corresponding weather data were collected from the National Oceanic and Atmospheric Administration stations, which in some instances were less than a mile from the subject's house, Dr. McAlindon said.
In all, the investigators identified more than 900 pain reports that correlated with weather. The data indicated that there was no significant association between pain scores and either the dew point or precipitation, which may be another reason previous studies have been confounded, he said.
It did, however, find a weak but consistent association between pain and temperature: Each degree (Fahrenheit) drop was associated with a one-degree increase in pain on the WOMAC scale. Similarly, the investigators found a strong association between pain and change in barometric pressure; this association was more pronounced with lower temperatures.
In keeping with the fact that patients tend to say they have greater pain before the weather changes, the pain-barometric pressure association did not occur so much with the drop in barometric pressure that accompanies a change in weather, but rather with the increase in barometric pressure that generally precedes a change in weather. Patients also often reported feeling better after a rain, which again is consistent with the fact that barometric pressure drops once a storm arrives, he added.
In a related report comparing 42 control subjects with 92 rheumatic disease patients, 80 of whom had osteoarthritis and 12 of whom had rheumatoid arthritis, José Vergés, M.D., of Bioiberica SA, a pharmaceutical company in Barcelona, Spain, found that patients with osteoarthritis, in particular, had more joint pain when atmospheric pressure was low.
Dr. Vergés concluded that “it may be possible to modulate pharmacological and nonpharmacological treatments for some osteoarthritic patients, depending on the predictable weather conditions in order to avoid, as much as possible, the disease-associated joint pain and functional incapacity” (Proc. West Pharmacol. Soc. 2004;47:134–6).
SAN ANTONIO — Physicians tend to be skeptical of arthritis patients' claims that they can feel bad weather coming on, but maybe they shouldn't be, Timothy E. McAlindon, M.D., said at the annual meeting of the American College of Rheumatology.
Findings from a study by Dr. McAlindon and his colleagues at Tufts-New England Medical Center, Boston, suggest that persons with knee osteoarthritis do have greater pain when there are changes in barometric pressure.
Previous studies probably have failed to document this phenomenon because they have not been able to be as precise in their weather measurements as this study, surmised Dr. McAlindon, chief of the division of rheumatology at Tufts.
The investigators collected data on 205 patients who took part in a 3-month trial of glucosamine that tracked participants using the Internet, which enabled them to be from a variety of regions within the U.S. The subjects lived in 41 different states; almost all of them experienced very different weather.
During the initial study, which found no positive effect from glucosamine, subjects completed Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain questionnaires every 2 weeks.
Corresponding weather data were collected from the National Oceanic and Atmospheric Administration stations, which in some instances were less than a mile from the subject's house, Dr. McAlindon said.
In all, the investigators identified more than 900 pain reports that correlated with weather. The data indicated that there was no significant association between pain scores and either the dew point or precipitation, which may be another reason previous studies have been confounded, he said.
It did, however, find a weak but consistent association between pain and temperature: Each degree (Fahrenheit) drop was associated with a one-degree increase in pain on the WOMAC scale. Similarly, the investigators found a strong association between pain and change in barometric pressure; this association was more pronounced with lower temperatures.
In keeping with the fact that patients tend to say they have greater pain before the weather changes, the pain-barometric pressure association did not occur so much with the drop in barometric pressure that accompanies a change in weather, but rather with the increase in barometric pressure that generally precedes a change in weather. Patients also often reported feeling better after a rain, which again is consistent with the fact that barometric pressure drops once a storm arrives, he added.
In a related report comparing 42 control subjects with 92 rheumatic disease patients, 80 of whom had osteoarthritis and 12 of whom had rheumatoid arthritis, José Vergés, M.D., of Bioiberica SA, a pharmaceutical company in Barcelona, Spain, found that patients with osteoarthritis, in particular, had more joint pain when atmospheric pressure was low.
Dr. Vergés concluded that “it may be possible to modulate pharmacological and nonpharmacological treatments for some osteoarthritic patients, depending on the predictable weather conditions in order to avoid, as much as possible, the disease-associated joint pain and functional incapacity” (Proc. West Pharmacol. Soc. 2004;47:134–6).
SAN ANTONIO — Physicians tend to be skeptical of arthritis patients' claims that they can feel bad weather coming on, but maybe they shouldn't be, Timothy E. McAlindon, M.D., said at the annual meeting of the American College of Rheumatology.
Findings from a study by Dr. McAlindon and his colleagues at Tufts-New England Medical Center, Boston, suggest that persons with knee osteoarthritis do have greater pain when there are changes in barometric pressure.
Previous studies probably have failed to document this phenomenon because they have not been able to be as precise in their weather measurements as this study, surmised Dr. McAlindon, chief of the division of rheumatology at Tufts.
The investigators collected data on 205 patients who took part in a 3-month trial of glucosamine that tracked participants using the Internet, which enabled them to be from a variety of regions within the U.S. The subjects lived in 41 different states; almost all of them experienced very different weather.
During the initial study, which found no positive effect from glucosamine, subjects completed Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain questionnaires every 2 weeks.
Corresponding weather data were collected from the National Oceanic and Atmospheric Administration stations, which in some instances were less than a mile from the subject's house, Dr. McAlindon said.
In all, the investigators identified more than 900 pain reports that correlated with weather. The data indicated that there was no significant association between pain scores and either the dew point or precipitation, which may be another reason previous studies have been confounded, he said.
It did, however, find a weak but consistent association between pain and temperature: Each degree (Fahrenheit) drop was associated with a one-degree increase in pain on the WOMAC scale. Similarly, the investigators found a strong association between pain and change in barometric pressure; this association was more pronounced with lower temperatures.
In keeping with the fact that patients tend to say they have greater pain before the weather changes, the pain-barometric pressure association did not occur so much with the drop in barometric pressure that accompanies a change in weather, but rather with the increase in barometric pressure that generally precedes a change in weather. Patients also often reported feeling better after a rain, which again is consistent with the fact that barometric pressure drops once a storm arrives, he added.
In a related report comparing 42 control subjects with 92 rheumatic disease patients, 80 of whom had osteoarthritis and 12 of whom had rheumatoid arthritis, José Vergés, M.D., of Bioiberica SA, a pharmaceutical company in Barcelona, Spain, found that patients with osteoarthritis, in particular, had more joint pain when atmospheric pressure was low.
Dr. Vergés concluded that “it may be possible to modulate pharmacological and nonpharmacological treatments for some osteoarthritic patients, depending on the predictable weather conditions in order to avoid, as much as possible, the disease-associated joint pain and functional incapacity” (Proc. West Pharmacol. Soc. 2004;47:134–6).
Glucosamine's Benefits Supported in 5-Year Study
SAN ANTONIO — Glucosamine appears superior to many other osteoarthritis agents in reducing pain and disability, according to the findings of a 5-year observational study.
Among 1,376 patients with osteoarthritis, those who took glucosamine consistently had Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index scores that were a mean 1.8 points lower than the scores of similar patients not taking glucosamine, Elizabeth Badley, Ph.D., reported at the annual meeting of the American College of Rheumatology.
At baseline, 9% of participants were using glucosamine, 42% were using NSAIDs, 62% were taking other pain medications, 2% were using steroid injections, 50% were using walking aids, and 92% were using lower-extremity devices.
Compared with glucosamine, none of the other treatments was associated with comparable improvements in WOMAC scores, which reflect disability and pain based on responses to a 24-item questionnaire, said Dr. Badley, director of the arthritis community research and evaluation unit at the University of Toronto.
All patients had knee or hip osteoarthritis, and their mean age at baseline was 72 years.
By the end of the 5-year period, 17% of patients were taking glucosamine. No dosage information was available.
“Whether it was the glucosamine or whether it was the people who take glucosamine, we don't know,” Dr. Badley said in an interview. “But clearly, we need to investigate this finding further.”
Some of the other factors associated with the lower WOMAC scores included younger age, higher level of education, and male gender. The men's WOMAC scores were on average 4 points lower than those of women with similar demographic profiles and treatments.
Dr. Badley reported no financial interest in glucosamine or in companies that manufacture the dietary supplement.
SAN ANTONIO — Glucosamine appears superior to many other osteoarthritis agents in reducing pain and disability, according to the findings of a 5-year observational study.
Among 1,376 patients with osteoarthritis, those who took glucosamine consistently had Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index scores that were a mean 1.8 points lower than the scores of similar patients not taking glucosamine, Elizabeth Badley, Ph.D., reported at the annual meeting of the American College of Rheumatology.
At baseline, 9% of participants were using glucosamine, 42% were using NSAIDs, 62% were taking other pain medications, 2% were using steroid injections, 50% were using walking aids, and 92% were using lower-extremity devices.
Compared with glucosamine, none of the other treatments was associated with comparable improvements in WOMAC scores, which reflect disability and pain based on responses to a 24-item questionnaire, said Dr. Badley, director of the arthritis community research and evaluation unit at the University of Toronto.
All patients had knee or hip osteoarthritis, and their mean age at baseline was 72 years.
By the end of the 5-year period, 17% of patients were taking glucosamine. No dosage information was available.
“Whether it was the glucosamine or whether it was the people who take glucosamine, we don't know,” Dr. Badley said in an interview. “But clearly, we need to investigate this finding further.”
Some of the other factors associated with the lower WOMAC scores included younger age, higher level of education, and male gender. The men's WOMAC scores were on average 4 points lower than those of women with similar demographic profiles and treatments.
Dr. Badley reported no financial interest in glucosamine or in companies that manufacture the dietary supplement.
SAN ANTONIO — Glucosamine appears superior to many other osteoarthritis agents in reducing pain and disability, according to the findings of a 5-year observational study.
Among 1,376 patients with osteoarthritis, those who took glucosamine consistently had Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index scores that were a mean 1.8 points lower than the scores of similar patients not taking glucosamine, Elizabeth Badley, Ph.D., reported at the annual meeting of the American College of Rheumatology.
At baseline, 9% of participants were using glucosamine, 42% were using NSAIDs, 62% were taking other pain medications, 2% were using steroid injections, 50% were using walking aids, and 92% were using lower-extremity devices.
Compared with glucosamine, none of the other treatments was associated with comparable improvements in WOMAC scores, which reflect disability and pain based on responses to a 24-item questionnaire, said Dr. Badley, director of the arthritis community research and evaluation unit at the University of Toronto.
All patients had knee or hip osteoarthritis, and their mean age at baseline was 72 years.
By the end of the 5-year period, 17% of patients were taking glucosamine. No dosage information was available.
“Whether it was the glucosamine or whether it was the people who take glucosamine, we don't know,” Dr. Badley said in an interview. “But clearly, we need to investigate this finding further.”
Some of the other factors associated with the lower WOMAC scores included younger age, higher level of education, and male gender. The men's WOMAC scores were on average 4 points lower than those of women with similar demographic profiles and treatments.
Dr. Badley reported no financial interest in glucosamine or in companies that manufacture the dietary supplement.
Pyrocarbon Implant Promising for Carpometacarpal Arthritis of Thumb
FAJARDO, P.R. — A new strategy for performing hemiarthroplasty for arthritis in the thumb carpometacarpal joint, appears to reduce pain and improve function.
The procedure involves using a pyrolytic carbon metacarpophalangeal (MCP) metacarpal head implant, Robert Beckenbaugh, M.D., said at the annual meeting of the American Association for Hand Surgery.
Previous implants of the thumb's carpometacarpal joint have involved using a round zirconium prosthesis that provided relief of pain and discomfort and ranked high in patient satisfaction. However, significant subsidence of the zirconium balls occurred.
A German surgeon, attempting to address this adverse event and create a stronger joint, developed the new procedure using the pyrocarbon implant, he explained.
Initial experience with 12 patients suggests that the procedure leads to early functional improvements during the postoperative course, and excellent mobility and pain relief up to 7 months later, said Dr. Beckenbaugh of the Mayo Clinic, Rochester, Minn.
The implant is inserted into the base of the thumb metacarpal, and the acetabulum for the implant is prepared in the distal end of the trapezium. The patient remains in a cast for 6 weeks.
Impressed by the 1-year results reported from Germany, Dr. Beckenbaugh traveled there to learn the technique. Early results suggest such outcomes are occurring in his patients as well.
In his case series of 12 patients with rheumatoid arthritis, psoriatic arthritis, or osteoarthritis, after at least 3 months follow-up, half reported 100% pain relief postoperatively, and the other half reported only occasional pain. There has been no change in grip strength, but the improvements in pain have been significant.
One patient, a 45-year-old with severe rheumatoid arthritis and no use of her thumb, reported good function and no pain at 7 months follow-up. She had good stability of the carpometacarpal joint.
Another patient who had 2 years of unsuccessful conservative treatment for osteoarthritis, underwent the procedure and experienced significant pain reduction and now has no difficulty opposing her thumb to her index or small fingers.
This preliminary experience with the pyrocarbon implant suggests that it is of benefit for patients with carpometacarpal arthritis, Dr. Beckenbaugh concluded.
FAJARDO, P.R. — A new strategy for performing hemiarthroplasty for arthritis in the thumb carpometacarpal joint, appears to reduce pain and improve function.
The procedure involves using a pyrolytic carbon metacarpophalangeal (MCP) metacarpal head implant, Robert Beckenbaugh, M.D., said at the annual meeting of the American Association for Hand Surgery.
Previous implants of the thumb's carpometacarpal joint have involved using a round zirconium prosthesis that provided relief of pain and discomfort and ranked high in patient satisfaction. However, significant subsidence of the zirconium balls occurred.
A German surgeon, attempting to address this adverse event and create a stronger joint, developed the new procedure using the pyrocarbon implant, he explained.
Initial experience with 12 patients suggests that the procedure leads to early functional improvements during the postoperative course, and excellent mobility and pain relief up to 7 months later, said Dr. Beckenbaugh of the Mayo Clinic, Rochester, Minn.
The implant is inserted into the base of the thumb metacarpal, and the acetabulum for the implant is prepared in the distal end of the trapezium. The patient remains in a cast for 6 weeks.
Impressed by the 1-year results reported from Germany, Dr. Beckenbaugh traveled there to learn the technique. Early results suggest such outcomes are occurring in his patients as well.
In his case series of 12 patients with rheumatoid arthritis, psoriatic arthritis, or osteoarthritis, after at least 3 months follow-up, half reported 100% pain relief postoperatively, and the other half reported only occasional pain. There has been no change in grip strength, but the improvements in pain have been significant.
One patient, a 45-year-old with severe rheumatoid arthritis and no use of her thumb, reported good function and no pain at 7 months follow-up. She had good stability of the carpometacarpal joint.
Another patient who had 2 years of unsuccessful conservative treatment for osteoarthritis, underwent the procedure and experienced significant pain reduction and now has no difficulty opposing her thumb to her index or small fingers.
This preliminary experience with the pyrocarbon implant suggests that it is of benefit for patients with carpometacarpal arthritis, Dr. Beckenbaugh concluded.
FAJARDO, P.R. — A new strategy for performing hemiarthroplasty for arthritis in the thumb carpometacarpal joint, appears to reduce pain and improve function.
The procedure involves using a pyrolytic carbon metacarpophalangeal (MCP) metacarpal head implant, Robert Beckenbaugh, M.D., said at the annual meeting of the American Association for Hand Surgery.
Previous implants of the thumb's carpometacarpal joint have involved using a round zirconium prosthesis that provided relief of pain and discomfort and ranked high in patient satisfaction. However, significant subsidence of the zirconium balls occurred.
A German surgeon, attempting to address this adverse event and create a stronger joint, developed the new procedure using the pyrocarbon implant, he explained.
Initial experience with 12 patients suggests that the procedure leads to early functional improvements during the postoperative course, and excellent mobility and pain relief up to 7 months later, said Dr. Beckenbaugh of the Mayo Clinic, Rochester, Minn.
The implant is inserted into the base of the thumb metacarpal, and the acetabulum for the implant is prepared in the distal end of the trapezium. The patient remains in a cast for 6 weeks.
Impressed by the 1-year results reported from Germany, Dr. Beckenbaugh traveled there to learn the technique. Early results suggest such outcomes are occurring in his patients as well.
In his case series of 12 patients with rheumatoid arthritis, psoriatic arthritis, or osteoarthritis, after at least 3 months follow-up, half reported 100% pain relief postoperatively, and the other half reported only occasional pain. There has been no change in grip strength, but the improvements in pain have been significant.
One patient, a 45-year-old with severe rheumatoid arthritis and no use of her thumb, reported good function and no pain at 7 months follow-up. She had good stability of the carpometacarpal joint.
Another patient who had 2 years of unsuccessful conservative treatment for osteoarthritis, underwent the procedure and experienced significant pain reduction and now has no difficulty opposing her thumb to her index or small fingers.
This preliminary experience with the pyrocarbon implant suggests that it is of benefit for patients with carpometacarpal arthritis, Dr. Beckenbaugh concluded.
Use of Cement Advised in Arthroplasty of PIP Joint
FAJARDO, P.R. — Patients undergoing arthroplasty of the proximal interphalangeal joint should opt for the cement, Bruce Johnstone, M.D., advised at the annual meeting of the American Association for Hand Surgery.
In 2000, the Avanta surface replacement proximal interphalangeal (PIP) joint was modified to incorporate a titanium stemmed distal component that allows for press fit cementless fixation, Dr. Johnstone noted.
But ever since the product's modification, observational evidence suggests that loosening and subsiding occurs more frequently when cement is not used with this second-generation device, Dr. Johnstone explained.
In a study involving 49 joint replacements using the cement-optional device, 1 of 27 cemented implants with at least 1 year of follow-up loosened and subsided, and 18 of the 27 have had no loosening or subsiding in up to 6 years of follow-up.
Of 22 cementless implants, 10 have loosened or subsided in up to 3 years of follow-up, reported Dr. Johnstone of Royal Children's Hospital, Melbourne, Australia.
When loosening and subsiding has occurred, it is often with angulation that leads to the stems of the device penetrating the cortical bone.
At first the subsidence is typically asymptomatic. However, as it progresses, pain and stiffness tend to develop, he said.
As a precaution, it is best to use methylmethacrylate bone cement to fix the stems of the cement-optional Avanta PIP surface replacement arthroplasty, he recommended at the meeting.
Those with cemented implants experienced a significant decrease in their pain, with scores on the visual analog scale improving by 5 points or more, Dr. Johnstone said.
FAJARDO, P.R. — Patients undergoing arthroplasty of the proximal interphalangeal joint should opt for the cement, Bruce Johnstone, M.D., advised at the annual meeting of the American Association for Hand Surgery.
In 2000, the Avanta surface replacement proximal interphalangeal (PIP) joint was modified to incorporate a titanium stemmed distal component that allows for press fit cementless fixation, Dr. Johnstone noted.
But ever since the product's modification, observational evidence suggests that loosening and subsiding occurs more frequently when cement is not used with this second-generation device, Dr. Johnstone explained.
In a study involving 49 joint replacements using the cement-optional device, 1 of 27 cemented implants with at least 1 year of follow-up loosened and subsided, and 18 of the 27 have had no loosening or subsiding in up to 6 years of follow-up.
Of 22 cementless implants, 10 have loosened or subsided in up to 3 years of follow-up, reported Dr. Johnstone of Royal Children's Hospital, Melbourne, Australia.
When loosening and subsiding has occurred, it is often with angulation that leads to the stems of the device penetrating the cortical bone.
At first the subsidence is typically asymptomatic. However, as it progresses, pain and stiffness tend to develop, he said.
As a precaution, it is best to use methylmethacrylate bone cement to fix the stems of the cement-optional Avanta PIP surface replacement arthroplasty, he recommended at the meeting.
Those with cemented implants experienced a significant decrease in their pain, with scores on the visual analog scale improving by 5 points or more, Dr. Johnstone said.
FAJARDO, P.R. — Patients undergoing arthroplasty of the proximal interphalangeal joint should opt for the cement, Bruce Johnstone, M.D., advised at the annual meeting of the American Association for Hand Surgery.
In 2000, the Avanta surface replacement proximal interphalangeal (PIP) joint was modified to incorporate a titanium stemmed distal component that allows for press fit cementless fixation, Dr. Johnstone noted.
But ever since the product's modification, observational evidence suggests that loosening and subsiding occurs more frequently when cement is not used with this second-generation device, Dr. Johnstone explained.
In a study involving 49 joint replacements using the cement-optional device, 1 of 27 cemented implants with at least 1 year of follow-up loosened and subsided, and 18 of the 27 have had no loosening or subsiding in up to 6 years of follow-up.
Of 22 cementless implants, 10 have loosened or subsided in up to 3 years of follow-up, reported Dr. Johnstone of Royal Children's Hospital, Melbourne, Australia.
When loosening and subsiding has occurred, it is often with angulation that leads to the stems of the device penetrating the cortical bone.
At first the subsidence is typically asymptomatic. However, as it progresses, pain and stiffness tend to develop, he said.
As a precaution, it is best to use methylmethacrylate bone cement to fix the stems of the cement-optional Avanta PIP surface replacement arthroplasty, he recommended at the meeting.
Those with cemented implants experienced a significant decrease in their pain, with scores on the visual analog scale improving by 5 points or more, Dr. Johnstone said.
Hyaluronan Injections Match Steroids for Thumb Arthritis
NEW YORK — Injections of high molecular weight hyaluronan were as effective as corticosteroids in alleviating pain associated with arthritis of the trapeziometacarpal joint, Shalom Stahl, M.D., reported at the annual meeting of the American Society for Surgery of the Hand.
Trapeziometacarpal joint arthritis is a disabling condition that presents with pain at the base of the thumb, causing impairment of hand function. Early disease is usually treated conservatively with splints, rest, and nonsteroidal anti-inflammatory drugs.
Occasionally, intraarticular injections of corticosteroids also are given, but this treatment has unpredictable efficacy and the potential for adverse events, such as infection and subcutaneous fat degeneration, that can cause additional disability, Dr. Stahl said.
High molecular weight hyaluronan (Orthovisc) is indicated for the relief of pain in knee osteoarthritis.
It is intended to restore the viscoelastic properties of the joint lining in patients who are in the early stages of osteoarthritis, said Dr. Stahl of the hand surgery unit, Rambam Medical Center, Haifa, Israel.
A total of 52 patients with grade 2 trapeziometacarpal joint arthritis were prospectively randomized to injections of 40 mg methylprednisolone acetate or 15 mg hyaluronate.
Patients were evaluated for pain severity, pinch and grip strength, and function before injection and 1, 3, and 6 months later.
Both groups experienced similar degrees of pain reduction. In the corticosteroid group, pain evaluated on a visual analog scale fell from a mean of 4.5 to 2.8; in the hyaluronate group, it decreased from 4.2 to 2.3.
Grip strength improved significantly throughout the 6-month follow-up period in the corticosteroid group but only at the 6-month point in the hyaluronate group.
Pinch strength, considered a proxy for functional improvement, improved at 6 months in the hyaluronate group but not in the corticosteroid group.
“Additionally, a significant improvement in the three-point pinch, lateral pinch, and physical performance test has been observed in the Orthovisc group starting at 3 months' follow-up,” Dr. Stahl said.
“We believe that sodium hyaluronate actually works on the basic process of the degenerative arthritic changes, whereas the corticosteroid addresses only the inflammatory component,”Dr. Stahl said.
NEW YORK — Injections of high molecular weight hyaluronan were as effective as corticosteroids in alleviating pain associated with arthritis of the trapeziometacarpal joint, Shalom Stahl, M.D., reported at the annual meeting of the American Society for Surgery of the Hand.
Trapeziometacarpal joint arthritis is a disabling condition that presents with pain at the base of the thumb, causing impairment of hand function. Early disease is usually treated conservatively with splints, rest, and nonsteroidal anti-inflammatory drugs.
Occasionally, intraarticular injections of corticosteroids also are given, but this treatment has unpredictable efficacy and the potential for adverse events, such as infection and subcutaneous fat degeneration, that can cause additional disability, Dr. Stahl said.
High molecular weight hyaluronan (Orthovisc) is indicated for the relief of pain in knee osteoarthritis.
It is intended to restore the viscoelastic properties of the joint lining in patients who are in the early stages of osteoarthritis, said Dr. Stahl of the hand surgery unit, Rambam Medical Center, Haifa, Israel.
A total of 52 patients with grade 2 trapeziometacarpal joint arthritis were prospectively randomized to injections of 40 mg methylprednisolone acetate or 15 mg hyaluronate.
Patients were evaluated for pain severity, pinch and grip strength, and function before injection and 1, 3, and 6 months later.
Both groups experienced similar degrees of pain reduction. In the corticosteroid group, pain evaluated on a visual analog scale fell from a mean of 4.5 to 2.8; in the hyaluronate group, it decreased from 4.2 to 2.3.
Grip strength improved significantly throughout the 6-month follow-up period in the corticosteroid group but only at the 6-month point in the hyaluronate group.
Pinch strength, considered a proxy for functional improvement, improved at 6 months in the hyaluronate group but not in the corticosteroid group.
“Additionally, a significant improvement in the three-point pinch, lateral pinch, and physical performance test has been observed in the Orthovisc group starting at 3 months' follow-up,” Dr. Stahl said.
“We believe that sodium hyaluronate actually works on the basic process of the degenerative arthritic changes, whereas the corticosteroid addresses only the inflammatory component,”Dr. Stahl said.
NEW YORK — Injections of high molecular weight hyaluronan were as effective as corticosteroids in alleviating pain associated with arthritis of the trapeziometacarpal joint, Shalom Stahl, M.D., reported at the annual meeting of the American Society for Surgery of the Hand.
Trapeziometacarpal joint arthritis is a disabling condition that presents with pain at the base of the thumb, causing impairment of hand function. Early disease is usually treated conservatively with splints, rest, and nonsteroidal anti-inflammatory drugs.
Occasionally, intraarticular injections of corticosteroids also are given, but this treatment has unpredictable efficacy and the potential for adverse events, such as infection and subcutaneous fat degeneration, that can cause additional disability, Dr. Stahl said.
High molecular weight hyaluronan (Orthovisc) is indicated for the relief of pain in knee osteoarthritis.
It is intended to restore the viscoelastic properties of the joint lining in patients who are in the early stages of osteoarthritis, said Dr. Stahl of the hand surgery unit, Rambam Medical Center, Haifa, Israel.
A total of 52 patients with grade 2 trapeziometacarpal joint arthritis were prospectively randomized to injections of 40 mg methylprednisolone acetate or 15 mg hyaluronate.
Patients were evaluated for pain severity, pinch and grip strength, and function before injection and 1, 3, and 6 months later.
Both groups experienced similar degrees of pain reduction. In the corticosteroid group, pain evaluated on a visual analog scale fell from a mean of 4.5 to 2.8; in the hyaluronate group, it decreased from 4.2 to 2.3.
Grip strength improved significantly throughout the 6-month follow-up period in the corticosteroid group but only at the 6-month point in the hyaluronate group.
Pinch strength, considered a proxy for functional improvement, improved at 6 months in the hyaluronate group but not in the corticosteroid group.
“Additionally, a significant improvement in the three-point pinch, lateral pinch, and physical performance test has been observed in the Orthovisc group starting at 3 months' follow-up,” Dr. Stahl said.
“We believe that sodium hyaluronate actually works on the basic process of the degenerative arthritic changes, whereas the corticosteroid addresses only the inflammatory component,”Dr. Stahl said.
Wrist Fusion Offers Best Option for Kienböck's
NEW YORK — Wrist fusion is an irreversible procedure resulting in total loss of radiocarpal movement, but for patients with advanced Kienböck's disease, it is the treatment of choice, Anant Tambe, M.B., said at the annual meeting of the American Society for Surgery of the Hand.
Kienböck's disease is an avascular necrosis of the lunate bone; its etiology is unknown. In its advanced stages 3 and 4, the condition is characterized by progressive carpal collapse, arthritis, and significant disability. Patients with this condition typically undergo either wrist fusion or one of several types of limited carpal fusion, but there is no published evidence showing that any procedure is optimal, said Dr. Tambe, who conducted the study at the Wrightington, Wigan, and Leigh NHS Trust, England.
All patients with Kienböck's disease in the United Kingdom are referred to Wrightington Hospital in Wigan and are entered into a registry, which currently consists of 223 patients, he said.
From this cohort, 18 were identified as having stage 3 or 4 disease and were retrospectively analyzed for outcome following surgery. Of these 18 patients, 6 had undergone wrist fusion and 12 had had limited carpal fusion.
The patients' average age was 39.6 years, and males predominated. The average follow-up was 61.8 months in the wrist fusion group and 66.8 months in the limited carpal fusion group.
Pain was rated on a visual analog scale. In the wrist fusion group, pain scores fell from a preoperative average of 8 to 3.3 following surgery, whereas in the carpal fusion group it decreased from a preoperative average of 8.9 to 7.2, Dr. Tambe said. The between-group difference was statistically significant.
On other measures, including the disability of arm, shoulder, and hand (DASH) score and the Short Form (SF)-12, which rates overall health status and grip strength, the limited carpal group fared slightly better. The differences were not statistically significant, however. Patient satisfaction was slightly higher in the wrist fusion group.
An important finding was that 4 of the 12 patients in the carpal fusion group had been advised to undergo wrist fusion. “At this time, three have undergone repeat surgery and one is awaiting surgery,” he commented.
An additional finding in the study was a predictable progressive pattern of arthritis, first with involvement of the midcarpal joints, then the radiolunate joint, then radioscaphoid involvement, and finally global arthritis, he said.
NEW YORK — Wrist fusion is an irreversible procedure resulting in total loss of radiocarpal movement, but for patients with advanced Kienböck's disease, it is the treatment of choice, Anant Tambe, M.B., said at the annual meeting of the American Society for Surgery of the Hand.
Kienböck's disease is an avascular necrosis of the lunate bone; its etiology is unknown. In its advanced stages 3 and 4, the condition is characterized by progressive carpal collapse, arthritis, and significant disability. Patients with this condition typically undergo either wrist fusion or one of several types of limited carpal fusion, but there is no published evidence showing that any procedure is optimal, said Dr. Tambe, who conducted the study at the Wrightington, Wigan, and Leigh NHS Trust, England.
All patients with Kienböck's disease in the United Kingdom are referred to Wrightington Hospital in Wigan and are entered into a registry, which currently consists of 223 patients, he said.
From this cohort, 18 were identified as having stage 3 or 4 disease and were retrospectively analyzed for outcome following surgery. Of these 18 patients, 6 had undergone wrist fusion and 12 had had limited carpal fusion.
The patients' average age was 39.6 years, and males predominated. The average follow-up was 61.8 months in the wrist fusion group and 66.8 months in the limited carpal fusion group.
Pain was rated on a visual analog scale. In the wrist fusion group, pain scores fell from a preoperative average of 8 to 3.3 following surgery, whereas in the carpal fusion group it decreased from a preoperative average of 8.9 to 7.2, Dr. Tambe said. The between-group difference was statistically significant.
On other measures, including the disability of arm, shoulder, and hand (DASH) score and the Short Form (SF)-12, which rates overall health status and grip strength, the limited carpal group fared slightly better. The differences were not statistically significant, however. Patient satisfaction was slightly higher in the wrist fusion group.
An important finding was that 4 of the 12 patients in the carpal fusion group had been advised to undergo wrist fusion. “At this time, three have undergone repeat surgery and one is awaiting surgery,” he commented.
An additional finding in the study was a predictable progressive pattern of arthritis, first with involvement of the midcarpal joints, then the radiolunate joint, then radioscaphoid involvement, and finally global arthritis, he said.
NEW YORK — Wrist fusion is an irreversible procedure resulting in total loss of radiocarpal movement, but for patients with advanced Kienböck's disease, it is the treatment of choice, Anant Tambe, M.B., said at the annual meeting of the American Society for Surgery of the Hand.
Kienböck's disease is an avascular necrosis of the lunate bone; its etiology is unknown. In its advanced stages 3 and 4, the condition is characterized by progressive carpal collapse, arthritis, and significant disability. Patients with this condition typically undergo either wrist fusion or one of several types of limited carpal fusion, but there is no published evidence showing that any procedure is optimal, said Dr. Tambe, who conducted the study at the Wrightington, Wigan, and Leigh NHS Trust, England.
All patients with Kienböck's disease in the United Kingdom are referred to Wrightington Hospital in Wigan and are entered into a registry, which currently consists of 223 patients, he said.
From this cohort, 18 were identified as having stage 3 or 4 disease and were retrospectively analyzed for outcome following surgery. Of these 18 patients, 6 had undergone wrist fusion and 12 had had limited carpal fusion.
The patients' average age was 39.6 years, and males predominated. The average follow-up was 61.8 months in the wrist fusion group and 66.8 months in the limited carpal fusion group.
Pain was rated on a visual analog scale. In the wrist fusion group, pain scores fell from a preoperative average of 8 to 3.3 following surgery, whereas in the carpal fusion group it decreased from a preoperative average of 8.9 to 7.2, Dr. Tambe said. The between-group difference was statistically significant.
On other measures, including the disability of arm, shoulder, and hand (DASH) score and the Short Form (SF)-12, which rates overall health status and grip strength, the limited carpal group fared slightly better. The differences were not statistically significant, however. Patient satisfaction was slightly higher in the wrist fusion group.
An important finding was that 4 of the 12 patients in the carpal fusion group had been advised to undergo wrist fusion. “At this time, three have undergone repeat surgery and one is awaiting surgery,” he commented.
An additional finding in the study was a predictable progressive pattern of arthritis, first with involvement of the midcarpal joints, then the radiolunate joint, then radioscaphoid involvement, and finally global arthritis, he said.
Preliminary Data Mixed on IL-15 as RA Target
SAN ANTONIO — The list of potential therapeutic targets in rheumatoid arthritis continues to expand, with preliminary evidence supporting the addition of the proinflammatory cytokine interleukin (IL)-15.
This signaling molecule, found in the synovium in those with rheumatoid arthritis (RA), appears early in the cascade of events that leads to inflammation, inducing the production of tumor necrosis factor (TNF)-α and recruiting inflammatory T cells.
A human monoclonal IgG antibody that binds to and inhibits IL-15 has been developed and is now undergoing clinical testing, Iain McInnes, M.D., said at the annual meeting of the American College of Rheumatology.
In an interim analysis of a proof-of-concept study of the antibody AMG 714, clinical effect was demonstrated at various doses in 110 patients with active RA, with the most pronounced benefit seen in the highest-dose group, he said.
Background methotrexate was permitted in stable doses of 25 mg/wk or less, but other disease-modifying drugs were not. None of the patients had previously received biologic response modifiers.
Stable limited doses of NSAIDs and corticosteroids were allowed.
Patients were randomized to receive placebo or AMG 714 in doses of 40 mg, 80 mg, 160 mg, or 280 mg, given by subcutaneous injection every 2 weeks for a 12-week period.
Among those patients in the highest dose group, 62% achieved an ACR 20 response, as did 26% in the placebo group; this between-group difference was statistically significant.
The response was maintained at week 14, though at that point, statistical significance was lost because of an increased placebo response, said Dr. McInnes, professor of experimental medicine and rheumatology at the Centre for Rheumatic Diseases, Glasgow, Scotland.
Approximately one-fourth of patients in the active treatment groups achieved an ACR 50 response, as did one patient in the placebo group. Some patients have achieved an ACR 70 response, but those data remain blinded, he said.
A 20% reduction in CRP was seen at weeks 4 and 14 in 29% and 39% of placebo patients, respectively, and in 70% and 63% of those in the high-dose AMG 714 group.
Worsening of RA was observed in 26% of placebo patients, compared with 5% of the high-dose treatment group.
Adverse events have been closely tracked in the study. “As this is the first time IL-15 is being targeted in humans, safety is our highest priority,” Dr. McInnes said.
Overall, the incidence of adverse events, such as infection, gastrointestinal complaints, and skin disorders, has been similar across the treatment and placebo groups. Approximately one-fourth of patients in the high-dose group have experienced transient injection-site reactions.
Two serious adverse events were reported. One was a case of deep venous thrombosis diagnosed 4 weeks after the last injection, and the other was sepsis following focal infection of a finger. Both resolved without sequelae, he said.
No deaths occurred during the trial.
“These are encouraging preliminary data,” he said in conclusion. An additional 70 patients now have entered the ongoing study.
Dr. McInnes disclosed a commercial relationship with Genmab A/S, the Copenhagen-based manufacturer of AMG 714.
SAN ANTONIO — The list of potential therapeutic targets in rheumatoid arthritis continues to expand, with preliminary evidence supporting the addition of the proinflammatory cytokine interleukin (IL)-15.
This signaling molecule, found in the synovium in those with rheumatoid arthritis (RA), appears early in the cascade of events that leads to inflammation, inducing the production of tumor necrosis factor (TNF)-α and recruiting inflammatory T cells.
A human monoclonal IgG antibody that binds to and inhibits IL-15 has been developed and is now undergoing clinical testing, Iain McInnes, M.D., said at the annual meeting of the American College of Rheumatology.
In an interim analysis of a proof-of-concept study of the antibody AMG 714, clinical effect was demonstrated at various doses in 110 patients with active RA, with the most pronounced benefit seen in the highest-dose group, he said.
Background methotrexate was permitted in stable doses of 25 mg/wk or less, but other disease-modifying drugs were not. None of the patients had previously received biologic response modifiers.
Stable limited doses of NSAIDs and corticosteroids were allowed.
Patients were randomized to receive placebo or AMG 714 in doses of 40 mg, 80 mg, 160 mg, or 280 mg, given by subcutaneous injection every 2 weeks for a 12-week period.
Among those patients in the highest dose group, 62% achieved an ACR 20 response, as did 26% in the placebo group; this between-group difference was statistically significant.
The response was maintained at week 14, though at that point, statistical significance was lost because of an increased placebo response, said Dr. McInnes, professor of experimental medicine and rheumatology at the Centre for Rheumatic Diseases, Glasgow, Scotland.
Approximately one-fourth of patients in the active treatment groups achieved an ACR 50 response, as did one patient in the placebo group. Some patients have achieved an ACR 70 response, but those data remain blinded, he said.
A 20% reduction in CRP was seen at weeks 4 and 14 in 29% and 39% of placebo patients, respectively, and in 70% and 63% of those in the high-dose AMG 714 group.
Worsening of RA was observed in 26% of placebo patients, compared with 5% of the high-dose treatment group.
Adverse events have been closely tracked in the study. “As this is the first time IL-15 is being targeted in humans, safety is our highest priority,” Dr. McInnes said.
Overall, the incidence of adverse events, such as infection, gastrointestinal complaints, and skin disorders, has been similar across the treatment and placebo groups. Approximately one-fourth of patients in the high-dose group have experienced transient injection-site reactions.
Two serious adverse events were reported. One was a case of deep venous thrombosis diagnosed 4 weeks after the last injection, and the other was sepsis following focal infection of a finger. Both resolved without sequelae, he said.
No deaths occurred during the trial.
“These are encouraging preliminary data,” he said in conclusion. An additional 70 patients now have entered the ongoing study.
Dr. McInnes disclosed a commercial relationship with Genmab A/S, the Copenhagen-based manufacturer of AMG 714.
SAN ANTONIO — The list of potential therapeutic targets in rheumatoid arthritis continues to expand, with preliminary evidence supporting the addition of the proinflammatory cytokine interleukin (IL)-15.
This signaling molecule, found in the synovium in those with rheumatoid arthritis (RA), appears early in the cascade of events that leads to inflammation, inducing the production of tumor necrosis factor (TNF)-α and recruiting inflammatory T cells.
A human monoclonal IgG antibody that binds to and inhibits IL-15 has been developed and is now undergoing clinical testing, Iain McInnes, M.D., said at the annual meeting of the American College of Rheumatology.
In an interim analysis of a proof-of-concept study of the antibody AMG 714, clinical effect was demonstrated at various doses in 110 patients with active RA, with the most pronounced benefit seen in the highest-dose group, he said.
Background methotrexate was permitted in stable doses of 25 mg/wk or less, but other disease-modifying drugs were not. None of the patients had previously received biologic response modifiers.
Stable limited doses of NSAIDs and corticosteroids were allowed.
Patients were randomized to receive placebo or AMG 714 in doses of 40 mg, 80 mg, 160 mg, or 280 mg, given by subcutaneous injection every 2 weeks for a 12-week period.
Among those patients in the highest dose group, 62% achieved an ACR 20 response, as did 26% in the placebo group; this between-group difference was statistically significant.
The response was maintained at week 14, though at that point, statistical significance was lost because of an increased placebo response, said Dr. McInnes, professor of experimental medicine and rheumatology at the Centre for Rheumatic Diseases, Glasgow, Scotland.
Approximately one-fourth of patients in the active treatment groups achieved an ACR 50 response, as did one patient in the placebo group. Some patients have achieved an ACR 70 response, but those data remain blinded, he said.
A 20% reduction in CRP was seen at weeks 4 and 14 in 29% and 39% of placebo patients, respectively, and in 70% and 63% of those in the high-dose AMG 714 group.
Worsening of RA was observed in 26% of placebo patients, compared with 5% of the high-dose treatment group.
Adverse events have been closely tracked in the study. “As this is the first time IL-15 is being targeted in humans, safety is our highest priority,” Dr. McInnes said.
Overall, the incidence of adverse events, such as infection, gastrointestinal complaints, and skin disorders, has been similar across the treatment and placebo groups. Approximately one-fourth of patients in the high-dose group have experienced transient injection-site reactions.
Two serious adverse events were reported. One was a case of deep venous thrombosis diagnosed 4 weeks after the last injection, and the other was sepsis following focal infection of a finger. Both resolved without sequelae, he said.
No deaths occurred during the trial.
“These are encouraging preliminary data,” he said in conclusion. An additional 70 patients now have entered the ongoing study.
Dr. McInnes disclosed a commercial relationship with Genmab A/S, the Copenhagen-based manufacturer of AMG 714.
Seven Years of Follow-Up Data Available on Etanercept
SAN ANTONIO — The safety and efficacy of etanercept have held up over time, with large cohorts of rheumatoid arthritis patients having been followed for as long as 7 years.
In a poster session at the annual meeting of the American College of Rheumatology, Michael E. Weinblatt, M.D., reported long-term efficacy results for two groups of American patients: 207 who at baseline had a history of having RA for 3 years or less and 644 who had long-standing disease that failed at least one disease-modifying antirheumatic drug.
The median length of exposure to etanercept in the early RA group was 5.5 years; in the long-standing RA group, it was 5.6 years. All patients had received dosages of 25 mg twice weekly by subcutaneous injection.
“Significant improvements in multiple measures of disease activity have been achieved with etanercept therapy,” he said. (See box.)
Concomitant medications were permitted during the extension studies, but most patients have been able to stop taking corticosteroids and methotrexate while receiving etanercept, said Dr. Weinblatt, professor of medicine, Harvard Medical School, Boston.
Patients who had received etanercept at any dose were included in the long-term safety analyses. Of this larger cohort, which included 558 early-disease patients and 884 long-standing disease patients, 323 (58%) and 391 (44%) of the early and long-standing disease patients, respectively, remain on the drug.
A total of 10% of the early disease group and 12% of the long-standing disease group discontinued the drug because of adverse effects.
There have been 28 deaths, including 4 from malignancy and 4 from cardiac disease, whereas 53 deaths were expected. There also have been 11 cases of sepsis but no cases of tuberculosis or opportunistic infections, Dr. Weinblatt said.
In a separate poster session, Larry W. Moreland, M.D., reported on a larger cohort of patients from North America and Europe who had been taking the drug. “Serious adverse events, infections, malignancies, and deaths do not increase over 7 years of treatment,” he said.
Analysis of data from that cohort of 2,054 patients, representing 7,382 patient-years of etanercept exposure, found that the rates of serious adverse events and serious infections were similar to those seen in control groups in previous trials. Rates of malignancies were similar to what was expected, with 67 observed and 61 expected.
A total of 42 patients died. “This death rate was lower than expected, as 53 deaths were expected in North America alone,” said Dr. Moreland, who holds the Anna Lois Waters Chair of Medicine in Rheumatology at the University of Alabama, Birmingham.
Of concern, however, are nine cases of lymphoma diagnosed in North America and one diagnosed in Europe. The incidence is higher than expected in the general population, and additional studies are needed to understand if this finding is related to etanercept or if it reflects the elevated risk of lymphoma inherent in patients with RA, Dr. Moreland said.
Both studies were funded by Immunex Corp., a subsidiary of Amgen Inc., and by Wyeth Research.
SAN ANTONIO — The safety and efficacy of etanercept have held up over time, with large cohorts of rheumatoid arthritis patients having been followed for as long as 7 years.
In a poster session at the annual meeting of the American College of Rheumatology, Michael E. Weinblatt, M.D., reported long-term efficacy results for two groups of American patients: 207 who at baseline had a history of having RA for 3 years or less and 644 who had long-standing disease that failed at least one disease-modifying antirheumatic drug.
The median length of exposure to etanercept in the early RA group was 5.5 years; in the long-standing RA group, it was 5.6 years. All patients had received dosages of 25 mg twice weekly by subcutaneous injection.
“Significant improvements in multiple measures of disease activity have been achieved with etanercept therapy,” he said. (See box.)
Concomitant medications were permitted during the extension studies, but most patients have been able to stop taking corticosteroids and methotrexate while receiving etanercept, said Dr. Weinblatt, professor of medicine, Harvard Medical School, Boston.
Patients who had received etanercept at any dose were included in the long-term safety analyses. Of this larger cohort, which included 558 early-disease patients and 884 long-standing disease patients, 323 (58%) and 391 (44%) of the early and long-standing disease patients, respectively, remain on the drug.
A total of 10% of the early disease group and 12% of the long-standing disease group discontinued the drug because of adverse effects.
There have been 28 deaths, including 4 from malignancy and 4 from cardiac disease, whereas 53 deaths were expected. There also have been 11 cases of sepsis but no cases of tuberculosis or opportunistic infections, Dr. Weinblatt said.
In a separate poster session, Larry W. Moreland, M.D., reported on a larger cohort of patients from North America and Europe who had been taking the drug. “Serious adverse events, infections, malignancies, and deaths do not increase over 7 years of treatment,” he said.
Analysis of data from that cohort of 2,054 patients, representing 7,382 patient-years of etanercept exposure, found that the rates of serious adverse events and serious infections were similar to those seen in control groups in previous trials. Rates of malignancies were similar to what was expected, with 67 observed and 61 expected.
A total of 42 patients died. “This death rate was lower than expected, as 53 deaths were expected in North America alone,” said Dr. Moreland, who holds the Anna Lois Waters Chair of Medicine in Rheumatology at the University of Alabama, Birmingham.
Of concern, however, are nine cases of lymphoma diagnosed in North America and one diagnosed in Europe. The incidence is higher than expected in the general population, and additional studies are needed to understand if this finding is related to etanercept or if it reflects the elevated risk of lymphoma inherent in patients with RA, Dr. Moreland said.
Both studies were funded by Immunex Corp., a subsidiary of Amgen Inc., and by Wyeth Research.
SAN ANTONIO — The safety and efficacy of etanercept have held up over time, with large cohorts of rheumatoid arthritis patients having been followed for as long as 7 years.
In a poster session at the annual meeting of the American College of Rheumatology, Michael E. Weinblatt, M.D., reported long-term efficacy results for two groups of American patients: 207 who at baseline had a history of having RA for 3 years or less and 644 who had long-standing disease that failed at least one disease-modifying antirheumatic drug.
The median length of exposure to etanercept in the early RA group was 5.5 years; in the long-standing RA group, it was 5.6 years. All patients had received dosages of 25 mg twice weekly by subcutaneous injection.
“Significant improvements in multiple measures of disease activity have been achieved with etanercept therapy,” he said. (See box.)
Concomitant medications were permitted during the extension studies, but most patients have been able to stop taking corticosteroids and methotrexate while receiving etanercept, said Dr. Weinblatt, professor of medicine, Harvard Medical School, Boston.
Patients who had received etanercept at any dose were included in the long-term safety analyses. Of this larger cohort, which included 558 early-disease patients and 884 long-standing disease patients, 323 (58%) and 391 (44%) of the early and long-standing disease patients, respectively, remain on the drug.
A total of 10% of the early disease group and 12% of the long-standing disease group discontinued the drug because of adverse effects.
There have been 28 deaths, including 4 from malignancy and 4 from cardiac disease, whereas 53 deaths were expected. There also have been 11 cases of sepsis but no cases of tuberculosis or opportunistic infections, Dr. Weinblatt said.
In a separate poster session, Larry W. Moreland, M.D., reported on a larger cohort of patients from North America and Europe who had been taking the drug. “Serious adverse events, infections, malignancies, and deaths do not increase over 7 years of treatment,” he said.
Analysis of data from that cohort of 2,054 patients, representing 7,382 patient-years of etanercept exposure, found that the rates of serious adverse events and serious infections were similar to those seen in control groups in previous trials. Rates of malignancies were similar to what was expected, with 67 observed and 61 expected.
A total of 42 patients died. “This death rate was lower than expected, as 53 deaths were expected in North America alone,” said Dr. Moreland, who holds the Anna Lois Waters Chair of Medicine in Rheumatology at the University of Alabama, Birmingham.
Of concern, however, are nine cases of lymphoma diagnosed in North America and one diagnosed in Europe. The incidence is higher than expected in the general population, and additional studies are needed to understand if this finding is related to etanercept or if it reflects the elevated risk of lymphoma inherent in patients with RA, Dr. Moreland said.
Both studies were funded by Immunex Corp., a subsidiary of Amgen Inc., and by Wyeth Research.
Simple Trapeziectomy Sufficient For Thumb Osteoarthritis
NEW YORK — Simple trapeziectomy offers as much benefit as more complicated, combined procedures for osteoarthritis of the trapeziometacarpal joint, Timothy R.C. Davis, M.D., said at the annual meeting of the American Society for Surgery of the Hand.
Trapeziectomy has been widely performed for this condition since its use was first reported in 1949. It fell out of favor because it was perceived as having a protracted recovery, and there was a belief that the inevitable shortening of the thumb would weaken that digit.
Concerns about postoperative arthritis or instability that could lead to persistent pain led to modifications of the procedure, Dr. Davis said.
One approach was to do a tendon interposition after trapeziectomy, using the palmaris longus. A second alternative was to do the tendon interposition plus an additional ligament reconstruction, which is probably the most commonly used technique today, he said.
“But neither of these procedures has ever been demonstrated to produce better outcomes than simple excision of the trapezium,” said Dr. Davis, professor of orthopaedics and accident surgery at the University of Nottingham (England).
A series of 183 thumbs in 162 women whose painful basal thumb osteoarthritis had not responded to medical therapy were randomized to one of the three procedures.
Additional procedures such as carpal tunnel decompressions were performed as necessary. Following the surgery, each thumb was immobilized in a plaster of paris spica for 6 weeks.
Once the plaster was removed patients were encouraged to mobilize the thumb and were given physiotherapy as needed.
Subjective assessments included evaluation of pain, weakness, stiffness, and the ability to perform activities of daily living.
At 3 months about 50% of patients in all groups reported little or no pain, and by 1 year, 82% had reached this level of pain relief. “But the pain relief was not influenced by the type of operation—it was as if we had done the same operation in all the patients,” Dr. Davis said.
By 1 year, 68% reported no weakness or interference with activities of daily living.
Mean thumb key pinch strength, evaluated with a pinch meter, improved significantly across all groups from 3.5 kg preoperatively to 4.6 kg at 1 year, but again the improvement was not influenced by the type of surgery performed, he said.
“In the short term at least, we concluded that palmaris longus interposition or ligament reconstruction did not improve the outcome of simple trapeziectomy with the insertion of a Kirschner wire and did not speed up recovery from the operation,” Dr. Davis said.
Five-year follow-up is ongoing, but the results will have to wait until about 2007, he added.
NEW YORK — Simple trapeziectomy offers as much benefit as more complicated, combined procedures for osteoarthritis of the trapeziometacarpal joint, Timothy R.C. Davis, M.D., said at the annual meeting of the American Society for Surgery of the Hand.
Trapeziectomy has been widely performed for this condition since its use was first reported in 1949. It fell out of favor because it was perceived as having a protracted recovery, and there was a belief that the inevitable shortening of the thumb would weaken that digit.
Concerns about postoperative arthritis or instability that could lead to persistent pain led to modifications of the procedure, Dr. Davis said.
One approach was to do a tendon interposition after trapeziectomy, using the palmaris longus. A second alternative was to do the tendon interposition plus an additional ligament reconstruction, which is probably the most commonly used technique today, he said.
“But neither of these procedures has ever been demonstrated to produce better outcomes than simple excision of the trapezium,” said Dr. Davis, professor of orthopaedics and accident surgery at the University of Nottingham (England).
A series of 183 thumbs in 162 women whose painful basal thumb osteoarthritis had not responded to medical therapy were randomized to one of the three procedures.
Additional procedures such as carpal tunnel decompressions were performed as necessary. Following the surgery, each thumb was immobilized in a plaster of paris spica for 6 weeks.
Once the plaster was removed patients were encouraged to mobilize the thumb and were given physiotherapy as needed.
Subjective assessments included evaluation of pain, weakness, stiffness, and the ability to perform activities of daily living.
At 3 months about 50% of patients in all groups reported little or no pain, and by 1 year, 82% had reached this level of pain relief. “But the pain relief was not influenced by the type of operation—it was as if we had done the same operation in all the patients,” Dr. Davis said.
By 1 year, 68% reported no weakness or interference with activities of daily living.
Mean thumb key pinch strength, evaluated with a pinch meter, improved significantly across all groups from 3.5 kg preoperatively to 4.6 kg at 1 year, but again the improvement was not influenced by the type of surgery performed, he said.
“In the short term at least, we concluded that palmaris longus interposition or ligament reconstruction did not improve the outcome of simple trapeziectomy with the insertion of a Kirschner wire and did not speed up recovery from the operation,” Dr. Davis said.
Five-year follow-up is ongoing, but the results will have to wait until about 2007, he added.
NEW YORK — Simple trapeziectomy offers as much benefit as more complicated, combined procedures for osteoarthritis of the trapeziometacarpal joint, Timothy R.C. Davis, M.D., said at the annual meeting of the American Society for Surgery of the Hand.
Trapeziectomy has been widely performed for this condition since its use was first reported in 1949. It fell out of favor because it was perceived as having a protracted recovery, and there was a belief that the inevitable shortening of the thumb would weaken that digit.
Concerns about postoperative arthritis or instability that could lead to persistent pain led to modifications of the procedure, Dr. Davis said.
One approach was to do a tendon interposition after trapeziectomy, using the palmaris longus. A second alternative was to do the tendon interposition plus an additional ligament reconstruction, which is probably the most commonly used technique today, he said.
“But neither of these procedures has ever been demonstrated to produce better outcomes than simple excision of the trapezium,” said Dr. Davis, professor of orthopaedics and accident surgery at the University of Nottingham (England).
A series of 183 thumbs in 162 women whose painful basal thumb osteoarthritis had not responded to medical therapy were randomized to one of the three procedures.
Additional procedures such as carpal tunnel decompressions were performed as necessary. Following the surgery, each thumb was immobilized in a plaster of paris spica for 6 weeks.
Once the plaster was removed patients were encouraged to mobilize the thumb and were given physiotherapy as needed.
Subjective assessments included evaluation of pain, weakness, stiffness, and the ability to perform activities of daily living.
At 3 months about 50% of patients in all groups reported little or no pain, and by 1 year, 82% had reached this level of pain relief. “But the pain relief was not influenced by the type of operation—it was as if we had done the same operation in all the patients,” Dr. Davis said.
By 1 year, 68% reported no weakness or interference with activities of daily living.
Mean thumb key pinch strength, evaluated with a pinch meter, improved significantly across all groups from 3.5 kg preoperatively to 4.6 kg at 1 year, but again the improvement was not influenced by the type of surgery performed, he said.
“In the short term at least, we concluded that palmaris longus interposition or ligament reconstruction did not improve the outcome of simple trapeziectomy with the insertion of a Kirschner wire and did not speed up recovery from the operation,” Dr. Davis said.
Five-year follow-up is ongoing, but the results will have to wait until about 2007, he added.
Rose Hip Reduces OA Hand Pain and Stiffness
CHICAGO — An herbal remedy made from a subspecies of rose hip (Rosa canina) significantly reduced pain in patients with osteoarthritis of the hand, compared with placebo, according to the results of a small, randomized controlled study.
The 32 patients in the study had osteoarthritis of at least one joint of the hand and were randomized to treatment with either five capsules of 0.5 g standardized rose hip powder or identical placebo twice daily for 3 months, after which the study arms were switched and patients took the alternative treatment for an additional 3 months.
During the two treatment periods, 88% of patients taking active treatment reported a reduction in pain, compared with 36% of those taking placebo, Kaj. Winther, M.D., said in a poster presentation at the 2004 World Congress on Osteoarthritis. C-reactive protein (CRP) levels also fell with active treatment.
Dr. Winther and his and colleagues at University Hospital Rigshospitalet in Copenhagen began looking for an alternative pain medication for his elderly patients with cardiovascular disease and thrombosis who also suffered from osteoarthritis.
“Nonsteroidals, aspirin, Cox-2 [inhibitors], etc., all had their side effects, and did not go well with warfarin,” Dr. Winther said at the congress, sponsored by the Osteoarthritis Research Society International.
In the current study, before and after each of the two treatment periods, patients evaluated their pain and stiffness while performing 1 of 15 different daily activities.
A 10-point scale was used to evaluate their pain, with a score of 10 being the most severe pain.
The mean age was 62 years, 28 patients were female, and all had a positive handgrip test. Eight patients were taking NSAIDs, 16 patients regularly took acetaminophen.
Taking the mean of all 15 activity scores, pain was significantly reduced while on active treatment, compared with placebo (4.8 vs. 5.3, respectively).
Evaluation of stiffness showed a similar pattern of improvement (4.6 active treatment vs. 5.1 placebo).
The overall feeling of discomfort from the disease was significantly reduced from 5.8 at baseline to 4.6 while on active treatment, compared with 5.7 and 5.5 for the placebo group.
The treatment with LitoZin, the formulation used in the study, was associated with significant decreases in serum C-reactive protein levels below baseline levels (P value of less than .05). CRP levels fell from a range of 4-23 mg/L at baseline to a range of 3.8-16 mg/L after treatment.
LitoZin, which is manufactured by Dansk Droge Ltd., Ishøj, Denmark, and distributed in Europe, is expected to be marketed in 2005 in the United States by EuroPharma Inc., Green Bay, Wis.
Side effects were comparable with placebo, and no patients dropped out of the study, reported Dr. Winther.
Dr. Winther disclosed that he has no financial interest in the product.
CHICAGO — An herbal remedy made from a subspecies of rose hip (Rosa canina) significantly reduced pain in patients with osteoarthritis of the hand, compared with placebo, according to the results of a small, randomized controlled study.
The 32 patients in the study had osteoarthritis of at least one joint of the hand and were randomized to treatment with either five capsules of 0.5 g standardized rose hip powder or identical placebo twice daily for 3 months, after which the study arms were switched and patients took the alternative treatment for an additional 3 months.
During the two treatment periods, 88% of patients taking active treatment reported a reduction in pain, compared with 36% of those taking placebo, Kaj. Winther, M.D., said in a poster presentation at the 2004 World Congress on Osteoarthritis. C-reactive protein (CRP) levels also fell with active treatment.
Dr. Winther and his and colleagues at University Hospital Rigshospitalet in Copenhagen began looking for an alternative pain medication for his elderly patients with cardiovascular disease and thrombosis who also suffered from osteoarthritis.
“Nonsteroidals, aspirin, Cox-2 [inhibitors], etc., all had their side effects, and did not go well with warfarin,” Dr. Winther said at the congress, sponsored by the Osteoarthritis Research Society International.
In the current study, before and after each of the two treatment periods, patients evaluated their pain and stiffness while performing 1 of 15 different daily activities.
A 10-point scale was used to evaluate their pain, with a score of 10 being the most severe pain.
The mean age was 62 years, 28 patients were female, and all had a positive handgrip test. Eight patients were taking NSAIDs, 16 patients regularly took acetaminophen.
Taking the mean of all 15 activity scores, pain was significantly reduced while on active treatment, compared with placebo (4.8 vs. 5.3, respectively).
Evaluation of stiffness showed a similar pattern of improvement (4.6 active treatment vs. 5.1 placebo).
The overall feeling of discomfort from the disease was significantly reduced from 5.8 at baseline to 4.6 while on active treatment, compared with 5.7 and 5.5 for the placebo group.
The treatment with LitoZin, the formulation used in the study, was associated with significant decreases in serum C-reactive protein levels below baseline levels (P value of less than .05). CRP levels fell from a range of 4-23 mg/L at baseline to a range of 3.8-16 mg/L after treatment.
LitoZin, which is manufactured by Dansk Droge Ltd., Ishøj, Denmark, and distributed in Europe, is expected to be marketed in 2005 in the United States by EuroPharma Inc., Green Bay, Wis.
Side effects were comparable with placebo, and no patients dropped out of the study, reported Dr. Winther.
Dr. Winther disclosed that he has no financial interest in the product.
CHICAGO — An herbal remedy made from a subspecies of rose hip (Rosa canina) significantly reduced pain in patients with osteoarthritis of the hand, compared with placebo, according to the results of a small, randomized controlled study.
The 32 patients in the study had osteoarthritis of at least one joint of the hand and were randomized to treatment with either five capsules of 0.5 g standardized rose hip powder or identical placebo twice daily for 3 months, after which the study arms were switched and patients took the alternative treatment for an additional 3 months.
During the two treatment periods, 88% of patients taking active treatment reported a reduction in pain, compared with 36% of those taking placebo, Kaj. Winther, M.D., said in a poster presentation at the 2004 World Congress on Osteoarthritis. C-reactive protein (CRP) levels also fell with active treatment.
Dr. Winther and his and colleagues at University Hospital Rigshospitalet in Copenhagen began looking for an alternative pain medication for his elderly patients with cardiovascular disease and thrombosis who also suffered from osteoarthritis.
“Nonsteroidals, aspirin, Cox-2 [inhibitors], etc., all had their side effects, and did not go well with warfarin,” Dr. Winther said at the congress, sponsored by the Osteoarthritis Research Society International.
In the current study, before and after each of the two treatment periods, patients evaluated their pain and stiffness while performing 1 of 15 different daily activities.
A 10-point scale was used to evaluate their pain, with a score of 10 being the most severe pain.
The mean age was 62 years, 28 patients were female, and all had a positive handgrip test. Eight patients were taking NSAIDs, 16 patients regularly took acetaminophen.
Taking the mean of all 15 activity scores, pain was significantly reduced while on active treatment, compared with placebo (4.8 vs. 5.3, respectively).
Evaluation of stiffness showed a similar pattern of improvement (4.6 active treatment vs. 5.1 placebo).
The overall feeling of discomfort from the disease was significantly reduced from 5.8 at baseline to 4.6 while on active treatment, compared with 5.7 and 5.5 for the placebo group.
The treatment with LitoZin, the formulation used in the study, was associated with significant decreases in serum C-reactive protein levels below baseline levels (P value of less than .05). CRP levels fell from a range of 4-23 mg/L at baseline to a range of 3.8-16 mg/L after treatment.
LitoZin, which is manufactured by Dansk Droge Ltd., Ishøj, Denmark, and distributed in Europe, is expected to be marketed in 2005 in the United States by EuroPharma Inc., Green Bay, Wis.
Side effects were comparable with placebo, and no patients dropped out of the study, reported Dr. Winther.
Dr. Winther disclosed that he has no financial interest in the product.