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For MD-IQ on Family Practice News, but a regular topic for Rheumatology News
Novel agent brings clinically meaningful improvements in knee osteoarthritis
LAS VEGAS – The investigational agent FX006 brought improvements in pain and function in patients with knee osteoarthritis that were not only statistically significant but also clinically meaningful by three different yardsticks, according to Scott Kelley, MD.
FX006 (Zilretta) is an extended-release, microsphere-based formulation of triamcinolone acetonide for intra-articular injection now under review for marketing approval by the Food and Drug Administration, which has said it will render a decision in October, Dr. Kelley reported at the World Congress on Osteoarthritis.
He presented a post hoc pooled analysis of the 798 patients with knee OA who participated in two phase II randomized, double-blind clinical trials and in an identically designed pivotal phase III trial of a single 40-mg intra-articular injection of FX006. The three studies included 324 patients who got FX006, 212 who received a single 40-mg intra-articular injection of standard triamcinolone acetonide crystalline suspension, and 262 who got a placebo injection of 5 mL of saline.
All participants had radiographically documented symptomatic knee OA with baseline daily pain scores of 6-9 on a 0-10 scale, corresponding to pain in the moderate-to-severe range. Patients telephoned in their average daily pain scores every day during the studies, one of which lasted 12 weeks while the other two ran for 24 weeks. Patients also visited their clinician every 4 weeks for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments of pain, stiffness, and physical function.
This secondary analysis was undertaken to demonstrate that FX006 distinguishes itself from current nonsurgical treatments for knee OA, which typically achieve clinical effects that are small, transient, and not clinically relevant, Dr. Kelley said at the congress sponsored by the Osteoarthritis Research Society International.
“What’s different about this product formulation is it maintains a prolonged release of triamcinolone acetonide inside the synovial fluid. The pharmacology has demonstrated prolonged residence time in synovial fluid out to at least 12 weeks after intra-articular administration. In addition, it mitigates the peak plasma level after intra-articular administration, so it blunts the level of corticosteroid in plasma and has a lower systemic exposure over time,” he said.
The clinical relevance of the outcomes achieved in the pooled studies was assessed using three different metrics: the American Academy of Orthopaedic Surgeons (AAOS) criteria for determining whether a result represents a minimal clinically important improvement; the Outcomes Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) “strict responder” definition; and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)–defined proportion of patients achieving substantial improvement in pain.
At the 4- and 8-week follow-up visits post injection, only the FX006 group achieved the AAOS threshold of improvement that’s deemed both statistically and clinically significant. Standard triamcinolone couldn’t reach that bar, even at week 4. This makes FX006 the first intra-articular treatment for knee OA to achieve this stringent standard for a clinically meaningful effect. By week 12, the improvement in pain in the FX006 group had slipped to the level of ‘‘statistically and possibly clinically significant.” At weeks 16-24 following a single injection, the FX006 results were no longer statistically or clinically significant.
A significantly greater percentage of the FX006 group met the OMERACT-OARSI strict responder definition of substantial pain improvement at weeks 4, 8, and 12, compared with the standard triamcinolone and placebo groups. The degree of pain improvement in the FX006 group remained superior to placebo through week 16. The OMERACT-OARSI definition of substantial improvement requires at least a 50% improvement in the WOMAC-A pain score plus an absolute improvement of 20 points or more on the WOMAC-A pain score or WOMAC-C physical function 100-point normalized scale.
Substantial clinical improvement as defined by the IMMPACT criteria requires at least a 50% improvement from baseline in the WOMAC-A pain score. Roughly 60% and 50% of the FX006 group met that standard at weeks 4 and 8, respectively, rates that were significantly higher than for standard triamcinolone. The FX006 group’s IMMPACT substantial improvement rate significantly exceeded that of placebo-treated controls throughout all 24 weeks.
These studies as well as the pooled analysis were funded by Flexion Therapeutics.
FX006 is a type of steroid for joint injection that is formulated to stay in the joint longer than typical steroids through the use of microsphere technology. Typical intra-articular steroid injections tend to provide benefit over the short term, and as described by the Cochrane review, the greatest effect is only moderate at 1-2 weeks and decreases from there, with small effects at 13 weeks and none at 26 weeks (Cochrane Database Syst Rev. 2015;10:CD005328).
As we have previously reported (Semin Arthritis Rheum. 2014;43:701-12), intra-articular corticosteroids are widely recommended by professional societies for the management of knee OA, although a specific formulation is not generally given. This compound may fill an important treatment gap by extending the efficacy of a treatment that is generally accepted as useful and safe for this common painful condition. Also, given the controversy surrounding other intra-articular therapies, it may provide a safe and effective alternative for patients who have not benefited from, or not tolerated, one or more traditional intra-articular steroid injection(s).
Amanda E. Nelson, MD, is with the division of rheumatology, allergy, and immunology and the Thurston Arthritis Research Center at the University of North Carolina, Chapel Hill. She is a consultant to GlaxoSmithKline and has received honoraria for online presentations for MedScape and QuantiaMD regarding OA treatment guidelines.
FX006 is a type of steroid for joint injection that is formulated to stay in the joint longer than typical steroids through the use of microsphere technology. Typical intra-articular steroid injections tend to provide benefit over the short term, and as described by the Cochrane review, the greatest effect is only moderate at 1-2 weeks and decreases from there, with small effects at 13 weeks and none at 26 weeks (Cochrane Database Syst Rev. 2015;10:CD005328).
As we have previously reported (Semin Arthritis Rheum. 2014;43:701-12), intra-articular corticosteroids are widely recommended by professional societies for the management of knee OA, although a specific formulation is not generally given. This compound may fill an important treatment gap by extending the efficacy of a treatment that is generally accepted as useful and safe for this common painful condition. Also, given the controversy surrounding other intra-articular therapies, it may provide a safe and effective alternative for patients who have not benefited from, or not tolerated, one or more traditional intra-articular steroid injection(s).
Amanda E. Nelson, MD, is with the division of rheumatology, allergy, and immunology and the Thurston Arthritis Research Center at the University of North Carolina, Chapel Hill. She is a consultant to GlaxoSmithKline and has received honoraria for online presentations for MedScape and QuantiaMD regarding OA treatment guidelines.
FX006 is a type of steroid for joint injection that is formulated to stay in the joint longer than typical steroids through the use of microsphere technology. Typical intra-articular steroid injections tend to provide benefit over the short term, and as described by the Cochrane review, the greatest effect is only moderate at 1-2 weeks and decreases from there, with small effects at 13 weeks and none at 26 weeks (Cochrane Database Syst Rev. 2015;10:CD005328).
As we have previously reported (Semin Arthritis Rheum. 2014;43:701-12), intra-articular corticosteroids are widely recommended by professional societies for the management of knee OA, although a specific formulation is not generally given. This compound may fill an important treatment gap by extending the efficacy of a treatment that is generally accepted as useful and safe for this common painful condition. Also, given the controversy surrounding other intra-articular therapies, it may provide a safe and effective alternative for patients who have not benefited from, or not tolerated, one or more traditional intra-articular steroid injection(s).
Amanda E. Nelson, MD, is with the division of rheumatology, allergy, and immunology and the Thurston Arthritis Research Center at the University of North Carolina, Chapel Hill. She is a consultant to GlaxoSmithKline and has received honoraria for online presentations for MedScape and QuantiaMD regarding OA treatment guidelines.
LAS VEGAS – The investigational agent FX006 brought improvements in pain and function in patients with knee osteoarthritis that were not only statistically significant but also clinically meaningful by three different yardsticks, according to Scott Kelley, MD.
FX006 (Zilretta) is an extended-release, microsphere-based formulation of triamcinolone acetonide for intra-articular injection now under review for marketing approval by the Food and Drug Administration, which has said it will render a decision in October, Dr. Kelley reported at the World Congress on Osteoarthritis.
He presented a post hoc pooled analysis of the 798 patients with knee OA who participated in two phase II randomized, double-blind clinical trials and in an identically designed pivotal phase III trial of a single 40-mg intra-articular injection of FX006. The three studies included 324 patients who got FX006, 212 who received a single 40-mg intra-articular injection of standard triamcinolone acetonide crystalline suspension, and 262 who got a placebo injection of 5 mL of saline.
All participants had radiographically documented symptomatic knee OA with baseline daily pain scores of 6-9 on a 0-10 scale, corresponding to pain in the moderate-to-severe range. Patients telephoned in their average daily pain scores every day during the studies, one of which lasted 12 weeks while the other two ran for 24 weeks. Patients also visited their clinician every 4 weeks for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments of pain, stiffness, and physical function.
This secondary analysis was undertaken to demonstrate that FX006 distinguishes itself from current nonsurgical treatments for knee OA, which typically achieve clinical effects that are small, transient, and not clinically relevant, Dr. Kelley said at the congress sponsored by the Osteoarthritis Research Society International.
“What’s different about this product formulation is it maintains a prolonged release of triamcinolone acetonide inside the synovial fluid. The pharmacology has demonstrated prolonged residence time in synovial fluid out to at least 12 weeks after intra-articular administration. In addition, it mitigates the peak plasma level after intra-articular administration, so it blunts the level of corticosteroid in plasma and has a lower systemic exposure over time,” he said.
The clinical relevance of the outcomes achieved in the pooled studies was assessed using three different metrics: the American Academy of Orthopaedic Surgeons (AAOS) criteria for determining whether a result represents a minimal clinically important improvement; the Outcomes Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) “strict responder” definition; and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)–defined proportion of patients achieving substantial improvement in pain.
At the 4- and 8-week follow-up visits post injection, only the FX006 group achieved the AAOS threshold of improvement that’s deemed both statistically and clinically significant. Standard triamcinolone couldn’t reach that bar, even at week 4. This makes FX006 the first intra-articular treatment for knee OA to achieve this stringent standard for a clinically meaningful effect. By week 12, the improvement in pain in the FX006 group had slipped to the level of ‘‘statistically and possibly clinically significant.” At weeks 16-24 following a single injection, the FX006 results were no longer statistically or clinically significant.
A significantly greater percentage of the FX006 group met the OMERACT-OARSI strict responder definition of substantial pain improvement at weeks 4, 8, and 12, compared with the standard triamcinolone and placebo groups. The degree of pain improvement in the FX006 group remained superior to placebo through week 16. The OMERACT-OARSI definition of substantial improvement requires at least a 50% improvement in the WOMAC-A pain score plus an absolute improvement of 20 points or more on the WOMAC-A pain score or WOMAC-C physical function 100-point normalized scale.
Substantial clinical improvement as defined by the IMMPACT criteria requires at least a 50% improvement from baseline in the WOMAC-A pain score. Roughly 60% and 50% of the FX006 group met that standard at weeks 4 and 8, respectively, rates that were significantly higher than for standard triamcinolone. The FX006 group’s IMMPACT substantial improvement rate significantly exceeded that of placebo-treated controls throughout all 24 weeks.
These studies as well as the pooled analysis were funded by Flexion Therapeutics.
LAS VEGAS – The investigational agent FX006 brought improvements in pain and function in patients with knee osteoarthritis that were not only statistically significant but also clinically meaningful by three different yardsticks, according to Scott Kelley, MD.
FX006 (Zilretta) is an extended-release, microsphere-based formulation of triamcinolone acetonide for intra-articular injection now under review for marketing approval by the Food and Drug Administration, which has said it will render a decision in October, Dr. Kelley reported at the World Congress on Osteoarthritis.
He presented a post hoc pooled analysis of the 798 patients with knee OA who participated in two phase II randomized, double-blind clinical trials and in an identically designed pivotal phase III trial of a single 40-mg intra-articular injection of FX006. The three studies included 324 patients who got FX006, 212 who received a single 40-mg intra-articular injection of standard triamcinolone acetonide crystalline suspension, and 262 who got a placebo injection of 5 mL of saline.
All participants had radiographically documented symptomatic knee OA with baseline daily pain scores of 6-9 on a 0-10 scale, corresponding to pain in the moderate-to-severe range. Patients telephoned in their average daily pain scores every day during the studies, one of which lasted 12 weeks while the other two ran for 24 weeks. Patients also visited their clinician every 4 weeks for Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments of pain, stiffness, and physical function.
This secondary analysis was undertaken to demonstrate that FX006 distinguishes itself from current nonsurgical treatments for knee OA, which typically achieve clinical effects that are small, transient, and not clinically relevant, Dr. Kelley said at the congress sponsored by the Osteoarthritis Research Society International.
“What’s different about this product formulation is it maintains a prolonged release of triamcinolone acetonide inside the synovial fluid. The pharmacology has demonstrated prolonged residence time in synovial fluid out to at least 12 weeks after intra-articular administration. In addition, it mitigates the peak plasma level after intra-articular administration, so it blunts the level of corticosteroid in plasma and has a lower systemic exposure over time,” he said.
The clinical relevance of the outcomes achieved in the pooled studies was assessed using three different metrics: the American Academy of Orthopaedic Surgeons (AAOS) criteria for determining whether a result represents a minimal clinically important improvement; the Outcomes Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) “strict responder” definition; and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)–defined proportion of patients achieving substantial improvement in pain.
At the 4- and 8-week follow-up visits post injection, only the FX006 group achieved the AAOS threshold of improvement that’s deemed both statistically and clinically significant. Standard triamcinolone couldn’t reach that bar, even at week 4. This makes FX006 the first intra-articular treatment for knee OA to achieve this stringent standard for a clinically meaningful effect. By week 12, the improvement in pain in the FX006 group had slipped to the level of ‘‘statistically and possibly clinically significant.” At weeks 16-24 following a single injection, the FX006 results were no longer statistically or clinically significant.
A significantly greater percentage of the FX006 group met the OMERACT-OARSI strict responder definition of substantial pain improvement at weeks 4, 8, and 12, compared with the standard triamcinolone and placebo groups. The degree of pain improvement in the FX006 group remained superior to placebo through week 16. The OMERACT-OARSI definition of substantial improvement requires at least a 50% improvement in the WOMAC-A pain score plus an absolute improvement of 20 points or more on the WOMAC-A pain score or WOMAC-C physical function 100-point normalized scale.
Substantial clinical improvement as defined by the IMMPACT criteria requires at least a 50% improvement from baseline in the WOMAC-A pain score. Roughly 60% and 50% of the FX006 group met that standard at weeks 4 and 8, respectively, rates that were significantly higher than for standard triamcinolone. The FX006 group’s IMMPACT substantial improvement rate significantly exceeded that of placebo-treated controls throughout all 24 weeks.
These studies as well as the pooled analysis were funded by Flexion Therapeutics.
AT OARSI 2017
Key clinical point:
Major finding: The investigational extended-release formulation of triamcinolone, known as FX006 (Zilretta), is the first intra-articular treatment for knee OA to meet the American Academy of Orthopaedic Surgeons’ stringent standard for a clinically meaningful, as opposed to merely statistically significant, effect.
Data source: A post hoc pooled analysis of three randomized, double-blind clinical trials involving nearly 800 patients with knee osteoarthritis.
Disclosures: The pooled analysis was funded by Flexion Therapeutics and presented by a company officer.
Knee osteoarthritis linked to premature mortality
LAS VEGAS – Knee osteoarthritis was independently associated with increased risk of premature mortality in the largest-ever meta-analysis to examine the issue, Kirsten M. Leyland, PhD, reported at the World Congress on Osteoarthritis.
The meta-analysis used individual patient-level data on 11,954 participants in six prospective observational cohort studies conducted in four countries. The key finding: Subjects with symptomatic and radiographically confirmed knee OA were at 17% greater risk of premature mortality, compared with pain-free, radiographically negative participants, independent of age, sex, and race, according to Dr. Leyland, a musculoskeletal epidemiologist at the University of Oxford (England).
The six prospective cohort studies included in the new analysis are well known in the field of osteoarthritis research: the Framingham (Mass.) Osteoarthritis Study, the Rotterdam (the Netherlands) Study, the Multicenter Osteoarthritis Study (MOST), the Johnston County (N.C.) Osteoarthritis Project, the Tasmanian Older Adult Cohort Study, and the Chingford (U.K.) 1000 Women Study. These studies feature 7.4-23.7 years of prospective follow-up.
In an interview, Dr. Leyland said that the current analysis uses all-cause mortality as the outcome because causes of death are recorded differently in the countries where the studies are taking place. It will take several more years for statisticians to harmonize the cause-of-death data and draw definitive conclusions; however, preliminary analysis suggests the causes of premature mortality in the knee OA patients are disproportionately cardiovascular, she added.
Dr. Leyland reported having no financial conflicts regarding the study, which was supported by Arthritis Research UK.
LAS VEGAS – Knee osteoarthritis was independently associated with increased risk of premature mortality in the largest-ever meta-analysis to examine the issue, Kirsten M. Leyland, PhD, reported at the World Congress on Osteoarthritis.
The meta-analysis used individual patient-level data on 11,954 participants in six prospective observational cohort studies conducted in four countries. The key finding: Subjects with symptomatic and radiographically confirmed knee OA were at 17% greater risk of premature mortality, compared with pain-free, radiographically negative participants, independent of age, sex, and race, according to Dr. Leyland, a musculoskeletal epidemiologist at the University of Oxford (England).
The six prospective cohort studies included in the new analysis are well known in the field of osteoarthritis research: the Framingham (Mass.) Osteoarthritis Study, the Rotterdam (the Netherlands) Study, the Multicenter Osteoarthritis Study (MOST), the Johnston County (N.C.) Osteoarthritis Project, the Tasmanian Older Adult Cohort Study, and the Chingford (U.K.) 1000 Women Study. These studies feature 7.4-23.7 years of prospective follow-up.
In an interview, Dr. Leyland said that the current analysis uses all-cause mortality as the outcome because causes of death are recorded differently in the countries where the studies are taking place. It will take several more years for statisticians to harmonize the cause-of-death data and draw definitive conclusions; however, preliminary analysis suggests the causes of premature mortality in the knee OA patients are disproportionately cardiovascular, she added.
Dr. Leyland reported having no financial conflicts regarding the study, which was supported by Arthritis Research UK.
LAS VEGAS – Knee osteoarthritis was independently associated with increased risk of premature mortality in the largest-ever meta-analysis to examine the issue, Kirsten M. Leyland, PhD, reported at the World Congress on Osteoarthritis.
The meta-analysis used individual patient-level data on 11,954 participants in six prospective observational cohort studies conducted in four countries. The key finding: Subjects with symptomatic and radiographically confirmed knee OA were at 17% greater risk of premature mortality, compared with pain-free, radiographically negative participants, independent of age, sex, and race, according to Dr. Leyland, a musculoskeletal epidemiologist at the University of Oxford (England).
The six prospective cohort studies included in the new analysis are well known in the field of osteoarthritis research: the Framingham (Mass.) Osteoarthritis Study, the Rotterdam (the Netherlands) Study, the Multicenter Osteoarthritis Study (MOST), the Johnston County (N.C.) Osteoarthritis Project, the Tasmanian Older Adult Cohort Study, and the Chingford (U.K.) 1000 Women Study. These studies feature 7.4-23.7 years of prospective follow-up.
In an interview, Dr. Leyland said that the current analysis uses all-cause mortality as the outcome because causes of death are recorded differently in the countries where the studies are taking place. It will take several more years for statisticians to harmonize the cause-of-death data and draw definitive conclusions; however, preliminary analysis suggests the causes of premature mortality in the knee OA patients are disproportionately cardiovascular, she added.
Dr. Leyland reported having no financial conflicts regarding the study, which was supported by Arthritis Research UK.
AT OARSI 2017
Key clinical point:
Major finding: Knee osteoarthritis is independently associated with a 17% increased likelihood of premature mortality.
Data source: This meta-analysis harmonized individual patient-level data drawn from six major prospective, population-based cohort studies worldwide.
Disclosures: The presenter reported having no financial conflicts regarding the study, which was supported by Arthritis Research UK.
Short course of prednisolone may help distinguish between RA and hand OA
A short course of prednisolone may help rheumatologists differentiate between patients with rheumatoid arthritis and osteoarthritis, a proof of concept study shows.
However, the investigators caution that a positive response to the 3-day steroid course does not confirm a diagnosis of rheumatoid arthritis (RA).
For many years, rheumatologists have been using short courses of prednisolone in unclear clinical situations to differentiate between inflammatory and non-inflammatory arthritis, according to the investigators led by Uta Kiltz, MD, from Rheumazentrum Ruhrgebiet, Herne, Germany.
The pilot part of the TryCort study involved 15 patients with confirmed osteoarthritis and 15 with rheumatoid arthritis who were given 1 g of paracetamol (acetaminophen) a day for 5 days, and on days 3-5, they were given a 20-mg dose of prednisolone (Arthritis Res Ther. 2017;19:73. doi: 10.1186/s13075-017-1279-z).
Results showed that the patients with RA had greater improvements in their pain scores (0-10 on a numerical rating scale), compared with OA patients. The mean percentage improvement in pain scores at day 5 was 52.3% in the RA group and 22.0% in the OA group.
The research team considered that a 40% improvement in pain scores was the best choice between sensitivity and specificity regarding a diagnosis of RA.
At this 40% improvement cut-off, the “pred-test” was positive in 11 patients with RA and in four patients with OA (P = .012), with a sensitivity and specificity for a diagnosis of RA of 73.3% for both measures.
In order to validate the test, the researchers enrolled 95 patients with pain in their fingers and hands but without a clear diagnosis. These patients completed the 5-day intervention, and then at week 12 a rheumatologist diagnosed 47 as having RA and 48 were thought to not have RA.
The patients with diagnosed RA had a higher reduction in pain scores during the treatment with prednisolone, compared with patients without RA.
The median percentage of improvement at day 5 was higher in patients with RA than in those without RA (50% [interquartile range, 30%-60%] vs. 20% [IQR, 10%-30%]; P = .001). Overall, 40 of the 95 patients had an improvement of more than 40% in pain levels on day 5, fulfilling the criteria of a positive pred-test.
However, the authors noted that 31 patients with RA had a positive pred-test (77.5%), compared with nine (22.5%) patients without RA (P greater than .001).
The sensitivity of the pred-test for a diagnosis of RA was 0.6 (95% confidence interval, 0.5-0.8) and the specificity was 0.8 (95% CI, 0.7-0.9). The positive and negative predictive values were 0.77 and 0.70, respectively.
The authors concluded that the pred-test “performed well” but not “perfectly well.”
“We are aware that the pred-test without confirmation of other surrogate markers is not helpful in clinical decision-making processes,” they said. “We, therefore, recommend use of the test in light of other confirming factors, such as history, physical examination, imaging, and laboratory results.”
The test could be used to triage patients from primary care to rheumatologist care, they suggested.
The study was financially supported by Rheumazentrum Ruhrgebiet. The authors declared no conflicts of interest.
A short course of prednisolone may help rheumatologists differentiate between patients with rheumatoid arthritis and osteoarthritis, a proof of concept study shows.
However, the investigators caution that a positive response to the 3-day steroid course does not confirm a diagnosis of rheumatoid arthritis (RA).
For many years, rheumatologists have been using short courses of prednisolone in unclear clinical situations to differentiate between inflammatory and non-inflammatory arthritis, according to the investigators led by Uta Kiltz, MD, from Rheumazentrum Ruhrgebiet, Herne, Germany.
The pilot part of the TryCort study involved 15 patients with confirmed osteoarthritis and 15 with rheumatoid arthritis who were given 1 g of paracetamol (acetaminophen) a day for 5 days, and on days 3-5, they were given a 20-mg dose of prednisolone (Arthritis Res Ther. 2017;19:73. doi: 10.1186/s13075-017-1279-z).
Results showed that the patients with RA had greater improvements in their pain scores (0-10 on a numerical rating scale), compared with OA patients. The mean percentage improvement in pain scores at day 5 was 52.3% in the RA group and 22.0% in the OA group.
The research team considered that a 40% improvement in pain scores was the best choice between sensitivity and specificity regarding a diagnosis of RA.
At this 40% improvement cut-off, the “pred-test” was positive in 11 patients with RA and in four patients with OA (P = .012), with a sensitivity and specificity for a diagnosis of RA of 73.3% for both measures.
In order to validate the test, the researchers enrolled 95 patients with pain in their fingers and hands but without a clear diagnosis. These patients completed the 5-day intervention, and then at week 12 a rheumatologist diagnosed 47 as having RA and 48 were thought to not have RA.
The patients with diagnosed RA had a higher reduction in pain scores during the treatment with prednisolone, compared with patients without RA.
The median percentage of improvement at day 5 was higher in patients with RA than in those without RA (50% [interquartile range, 30%-60%] vs. 20% [IQR, 10%-30%]; P = .001). Overall, 40 of the 95 patients had an improvement of more than 40% in pain levels on day 5, fulfilling the criteria of a positive pred-test.
However, the authors noted that 31 patients with RA had a positive pred-test (77.5%), compared with nine (22.5%) patients without RA (P greater than .001).
The sensitivity of the pred-test for a diagnosis of RA was 0.6 (95% confidence interval, 0.5-0.8) and the specificity was 0.8 (95% CI, 0.7-0.9). The positive and negative predictive values were 0.77 and 0.70, respectively.
The authors concluded that the pred-test “performed well” but not “perfectly well.”
“We are aware that the pred-test without confirmation of other surrogate markers is not helpful in clinical decision-making processes,” they said. “We, therefore, recommend use of the test in light of other confirming factors, such as history, physical examination, imaging, and laboratory results.”
The test could be used to triage patients from primary care to rheumatologist care, they suggested.
The study was financially supported by Rheumazentrum Ruhrgebiet. The authors declared no conflicts of interest.
A short course of prednisolone may help rheumatologists differentiate between patients with rheumatoid arthritis and osteoarthritis, a proof of concept study shows.
However, the investigators caution that a positive response to the 3-day steroid course does not confirm a diagnosis of rheumatoid arthritis (RA).
For many years, rheumatologists have been using short courses of prednisolone in unclear clinical situations to differentiate between inflammatory and non-inflammatory arthritis, according to the investigators led by Uta Kiltz, MD, from Rheumazentrum Ruhrgebiet, Herne, Germany.
The pilot part of the TryCort study involved 15 patients with confirmed osteoarthritis and 15 with rheumatoid arthritis who were given 1 g of paracetamol (acetaminophen) a day for 5 days, and on days 3-5, they were given a 20-mg dose of prednisolone (Arthritis Res Ther. 2017;19:73. doi: 10.1186/s13075-017-1279-z).
Results showed that the patients with RA had greater improvements in their pain scores (0-10 on a numerical rating scale), compared with OA patients. The mean percentage improvement in pain scores at day 5 was 52.3% in the RA group and 22.0% in the OA group.
The research team considered that a 40% improvement in pain scores was the best choice between sensitivity and specificity regarding a diagnosis of RA.
At this 40% improvement cut-off, the “pred-test” was positive in 11 patients with RA and in four patients with OA (P = .012), with a sensitivity and specificity for a diagnosis of RA of 73.3% for both measures.
In order to validate the test, the researchers enrolled 95 patients with pain in their fingers and hands but without a clear diagnosis. These patients completed the 5-day intervention, and then at week 12 a rheumatologist diagnosed 47 as having RA and 48 were thought to not have RA.
The patients with diagnosed RA had a higher reduction in pain scores during the treatment with prednisolone, compared with patients without RA.
The median percentage of improvement at day 5 was higher in patients with RA than in those without RA (50% [interquartile range, 30%-60%] vs. 20% [IQR, 10%-30%]; P = .001). Overall, 40 of the 95 patients had an improvement of more than 40% in pain levels on day 5, fulfilling the criteria of a positive pred-test.
However, the authors noted that 31 patients with RA had a positive pred-test (77.5%), compared with nine (22.5%) patients without RA (P greater than .001).
The sensitivity of the pred-test for a diagnosis of RA was 0.6 (95% confidence interval, 0.5-0.8) and the specificity was 0.8 (95% CI, 0.7-0.9). The positive and negative predictive values were 0.77 and 0.70, respectively.
The authors concluded that the pred-test “performed well” but not “perfectly well.”
“We are aware that the pred-test without confirmation of other surrogate markers is not helpful in clinical decision-making processes,” they said. “We, therefore, recommend use of the test in light of other confirming factors, such as history, physical examination, imaging, and laboratory results.”
The test could be used to triage patients from primary care to rheumatologist care, they suggested.
The study was financially supported by Rheumazentrum Ruhrgebiet. The authors declared no conflicts of interest.
FROM ARTHRITIS RESEARCH & THERAPY
Key clinical point:
Major finding: The sensitivity of the pred-test for a diagnosis of RA was 0.6 (95% CI, 0.5-0.8) and the specificity was 0.8 (95% CI, 0.7-0.9).
Data source: A pilot study of 20 mg of prednisolone for 3 days in 30 patients with established RA or OA followed by a validation study of the test in 95 patients with pain in their fingers and hands but without a clear diagnosis.
Disclosures: The study was financially supported by Rheumazentrum Ruhrgebiet. The authors declared no conflicts of interest.
Compounding rules challenge practice norms
As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.
In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.
In the same position statement on compounding, the ACR said it also seeks a change to a Food and Drug Administration rule limiting practitioners’ access to quinacrine, a drug only available through compounding pharmacies that is sometimes used to treat lupus patients. Quinacrine is not on the FDA’s current list of bulk substances approved for compounding, except by special permission. The ACR has asked the agency to add quinacrine to the list, but no one knows when this will happen.
Rheumatologists may also be more restricted than before in terms of which compounding pharmacies they can turn to, as new federal standards divide them into two types – those that can provide medicines in larger quantities and those that can’t.
Steroid fiasco sparked rule revisions
The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.
More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.
The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.
As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.
“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.
“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.
In-office mixing a top concern
Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.
Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.
Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.
Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”
USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.
“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.
“There’s that law of unintended consequences where you snare things in a net that you really don’t want to,” Dr. Huffstutter said.
Marcus Snow, MD, a rheumatologist at the University of Nebraska, Omaha, who also worked on the statement, said that most rheumatologists are likely unaware that their ability to mix drugs in-office has been called into question.
“I brought it up at our division meeting with a group of 10 rheumatologists, and no one was aware that this was coming down the pike,” Dr. Snow said in an interview.
Pediatric issues
Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.
They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.
“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.
Steroid injections can mean avoiding or delaying systemic treatment in children with oligoarticular arthritis, he said. “Most of us consider them a first-line therapy. The hope is that you can get by without having to use meds like methotrexate if you can get a prolonged response in the one or two joints that are active in that patient.”
But Dr. Reinhardt said that, while he mixed his own injections during his fellowship training, Children’s of Omaha now insists that they be prepared by in-house pharmacists, working under sterile hoods. The delay to receiving them in the clinic or procedure room is 40 minutes to an hour, he said, which the clinicians accommodate through careful scheduling.
The change from mixing in-clinic to relying on the central pharmacy came about in recent years, Dr. Reinhardt said, because of broader concerns related to medication storage in the clinics. While ordering from the central pharmacy works for his practice, he said, “I probably only inject maybe 50-70 joints a year, while adult rheumatologists are injecting far more than that. For a busy private practice, I can see that being a huge time constraint,” he said.
Relevance of rules
None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.
Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.
Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”
Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.
Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.
He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.
But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.
The quinacrine problem
A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.
“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”
Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”
Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.
While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.
Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.
Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.
As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.
In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.
In the same position statement on compounding, the ACR said it also seeks a change to a Food and Drug Administration rule limiting practitioners’ access to quinacrine, a drug only available through compounding pharmacies that is sometimes used to treat lupus patients. Quinacrine is not on the FDA’s current list of bulk substances approved for compounding, except by special permission. The ACR has asked the agency to add quinacrine to the list, but no one knows when this will happen.
Rheumatologists may also be more restricted than before in terms of which compounding pharmacies they can turn to, as new federal standards divide them into two types – those that can provide medicines in larger quantities and those that can’t.
Steroid fiasco sparked rule revisions
The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.
More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.
The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.
As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.
“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.
“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.
In-office mixing a top concern
Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.
Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.
Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.
Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”
USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.
“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.
“There’s that law of unintended consequences where you snare things in a net that you really don’t want to,” Dr. Huffstutter said.
Marcus Snow, MD, a rheumatologist at the University of Nebraska, Omaha, who also worked on the statement, said that most rheumatologists are likely unaware that their ability to mix drugs in-office has been called into question.
“I brought it up at our division meeting with a group of 10 rheumatologists, and no one was aware that this was coming down the pike,” Dr. Snow said in an interview.
Pediatric issues
Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.
They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.
“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.
Steroid injections can mean avoiding or delaying systemic treatment in children with oligoarticular arthritis, he said. “Most of us consider them a first-line therapy. The hope is that you can get by without having to use meds like methotrexate if you can get a prolonged response in the one or two joints that are active in that patient.”
But Dr. Reinhardt said that, while he mixed his own injections during his fellowship training, Children’s of Omaha now insists that they be prepared by in-house pharmacists, working under sterile hoods. The delay to receiving them in the clinic or procedure room is 40 minutes to an hour, he said, which the clinicians accommodate through careful scheduling.
The change from mixing in-clinic to relying on the central pharmacy came about in recent years, Dr. Reinhardt said, because of broader concerns related to medication storage in the clinics. While ordering from the central pharmacy works for his practice, he said, “I probably only inject maybe 50-70 joints a year, while adult rheumatologists are injecting far more than that. For a busy private practice, I can see that being a huge time constraint,” he said.
Relevance of rules
None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.
Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.
Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”
Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.
Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.
He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.
But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.
The quinacrine problem
A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.
“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”
Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”
Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.
While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.
Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.
Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.
As new rules about drug compounding get shaped, rheumatologists seek to protect their ability to combine injectable drugs – most commonly a steroid and a local anesthetic – in their own offices.
In a position statement sent to government agencies and members of Congress in February, the American College of Rheumatology voiced concerns that the practice, which it called “critical,” could become a casualty of drug-compounding regulations under revision by the United States Pharmacopeial Convention (USP), a nonprofit group whose standards are enforceable by state and federal regulators.
In the same position statement on compounding, the ACR said it also seeks a change to a Food and Drug Administration rule limiting practitioners’ access to quinacrine, a drug only available through compounding pharmacies that is sometimes used to treat lupus patients. Quinacrine is not on the FDA’s current list of bulk substances approved for compounding, except by special permission. The ACR has asked the agency to add quinacrine to the list, but no one knows when this will happen.
Rheumatologists may also be more restricted than before in terms of which compounding pharmacies they can turn to, as new federal standards divide them into two types – those that can provide medicines in larger quantities and those that can’t.
Steroid fiasco sparked rule revisions
The ACR’s concerns follow a tighter focus by state and federal agencies on drug compounding after a fungal meningitis outbreak in 2012 was traced to contaminated steroids produced in bulk by a compounding pharmacy.
More than 800 infections, 64 of them fatal, occurred after the New England Compounding Center in Framingham, Mass., sold contaminated methylprednisolone acetate that was used in epidural and intra-articular joint injections.
The following year Congress passed the Drug Quality and Security Act, which aims, in part, to prevent compounding pharmacies from engaging in what amounts to unregulated manufacturing.
As part of the law, the FDA created a list of drugs appropriate for compounding and a process by which larger compounding pharmacies must register with the FDA, and agree to inspections. The USP standards, meanwhile, address detailed technical and safety aspects of compounding and are enforceable by the FDA and state agencies.
“USP and FDA have had the ability to regulate compounding for over a decade, but only recently have the rules become actively enforced,” said Donald Miller, PharmD, of North Dakota State University, Fargo, who helped shape the ACR’s position statement on compounding with the help of rheumatologists in private practice.
“When you make guidelines for safety, they make sense, but then you can’t anticipate the way it’s going to affect individuals’ practice. And that’s where rheumatology got caught up,” said Dr. Miller, who was a member of the FDA Arthritis Advisory Committee in 2014-2016.
In-office mixing a top concern
Other specialties, including dermatology and immunology, also stand to be affected by various changes to compounding law and practice – and their societies have been active in voicing concerns.
Though the latest revisions of USP chapter 797, which impacts in-office mixing, are still being sorted out, it’s the No. 1 compounding-related concern for rheumatologists, Dr. Miller said.
Rheumatologists routinely mix an analgesic and a steroid for injection. The analgesic makes the steroids less viscous, and offers patients hours of immediate relief. They also add analgesics to hyaluronic acid injected for viscosupplementation. The mixing is usually conducted bedside, and the injections are administered right away.
Technically, combining these products amounts to sterile compounding, Dr. Miller explained. “And theoretically, under these rules, a physician could still do this, but they’d have to do it under a sterile hood like you find in a pharmacy, and that’s just not practical. It also becomes a matter of interpretation.”
USP chapter 797 sanctions in-office mixing for “immediate use” with individual patients – which is nearly always the case for the steroid injections used in rheumatology. But it’s unclear whether “immediate use” means emergency use only, or allows for routine use, as rheumatologists hope.
“One reason this came to rheumatology’s attention is that some state boards of medicine were inspecting and saying ‘Hey, you can’t do that,’ ” Dr. Miller said.
“There’s that law of unintended consequences where you snare things in a net that you really don’t want to,” Dr. Huffstutter said.
Marcus Snow, MD, a rheumatologist at the University of Nebraska, Omaha, who also worked on the statement, said that most rheumatologists are likely unaware that their ability to mix drugs in-office has been called into question.
“I brought it up at our division meeting with a group of 10 rheumatologists, and no one was aware that this was coming down the pike,” Dr. Snow said in an interview.
Pediatric issues
Pediatric rheumatologists, and adult rheumatologists who see children occasionally, use compounding pharmacies to create palatable oral medicines and adjusted doses of adult treatments.
They also use injections combining steroids with analgesics, and consider the addition of the analgesic a key aid to compliance.
“The biggest barrier we have is patient and parent anxiety about doing the procedure and the associated pain. We always administer our steroids mixed with lidocaine to help with the postprocedural discomfort,” said Adam Reinhardt, MD, chief of pediatric rheumatology at the University of Nebraska and Children’s Hospital and Medical Center in Omaha.
Steroid injections can mean avoiding or delaying systemic treatment in children with oligoarticular arthritis, he said. “Most of us consider them a first-line therapy. The hope is that you can get by without having to use meds like methotrexate if you can get a prolonged response in the one or two joints that are active in that patient.”
But Dr. Reinhardt said that, while he mixed his own injections during his fellowship training, Children’s of Omaha now insists that they be prepared by in-house pharmacists, working under sterile hoods. The delay to receiving them in the clinic or procedure room is 40 minutes to an hour, he said, which the clinicians accommodate through careful scheduling.
The change from mixing in-clinic to relying on the central pharmacy came about in recent years, Dr. Reinhardt said, because of broader concerns related to medication storage in the clinics. While ordering from the central pharmacy works for his practice, he said, “I probably only inject maybe 50-70 joints a year, while adult rheumatologists are injecting far more than that. For a busy private practice, I can see that being a huge time constraint,” he said.
Relevance of rules
None of the rheumatologists interviewed questioned the need for tightened state and federal oversight of compounding practices overall – just the applicability of certain rules to their own practice.
Dr. Snow and Dr. Huffstutter noted that reports of infected joints – a potential result of a contaminated injection – are sporadic and rare. “There’s very little research in this, but [these types of injections] have been standard practice for decades,” Dr. Snow said.
Srikanth Mukkera, MD, a rheumatologist in Tupelo, Miss., agreed that “sporadic cases of joint infection do happen following injection, but it can be hard to show if an injection was the cause.”
Assuring that medicines are mixed only immediately prior to injection, and not stored, reduces the likelihood of contamination, Dr. Mukkera said. Moreover, he noted, epidural injections such as those that resulted in the 2012 meningitis outbreak carry different risks than those seen in intra-articular injections.
Dr. Miller, the lead author of the ACR statement, said that the rheumatologists on our committee “don’t know of anyone that’s had a knee or other joint infection from a contaminated injection. They feel that unless somebody finds some evidence of that, they should be allowed to continue” with their usual practice.
He said that he feels that the USP will ultimately heed the concerns of rheumatologists and hopefully provide a more relaxed interpretation of in-office compounding. “We’re hoping they’ll make some exceptions when they revise 797 standards or at least maybe leave room for organizations to create a best practice statement. We’ll see,” Dr. Miller said.
But this is in no way guaranteed. Dr. Huffstutter said he fears that, if the rules come to be interpreted more narrowly, even standard practices like reconstituting biologic drugs for infusion – something that’s also a routine part of in-office practice – could fall under the rubric of sterile compounding and come into question.
The quinacrine problem
A separate compounding-related issue in rheumatology is clinicians’ access to quinacrine, an antimalarial rheumatology drug that, while infrequently used, represents the only alternative to hydroxychloroquine for some lupus patients.
“There are no alternatives out there for hydroxychloroquine, so we need it as a backup,” Dr. Snow said. “If hydroxychloroquine isn’t an option, there’s nothing out there that we can use. There’s no easy replacement.”
Dr. Huffstutter said he currently had no patients on quinacrine. “It’s not very often that we use it, but in those patients that really need it, it can make a huge difference in how they do.”
Quinacrine is no longer manufactured commercially as a finished drug product but is available in a powder that compounding physicians put into 100-mg capsules. It is not on the FDA’s current list of drugs available for compounding except with special permission.
While the ACR has requested that the FDA add it the list of bulk drug substances that can be used in compounding, quinacrine remains off the list for now – and, providers say, hard to find.
Moreover, while rheumatologists may have previously been able to order and store quantities of quinacrine and other compounded nonsterile medications to dispense to their patients, they can no longer easily do so, as only the FDA-approved compounding “outsourcing facilities” are allowed to process larger orders; the rest can only respond to prescriptions for individual patients.
Dr. Miller said it’s likely that quinacrine will make it onto the FDA’s next list of bulk drugs available for compounding. “The FDA has kind of said, ‘Don’t worry about it,’ ” he said.
Osteoarthritis’ link to metabolic syndrome tied to body weight, BMI
The metabolic syndrome’s association with the development of osteoarthritis appears to occur primarily through the influence of factors related to body weight or body mass index, according to an analysis of data from the longitudinal Framingham osteoarthritis study.
Jingbo Niu, DSc, of the Clinical Epidemiology Research and Training Unit at Boston University, and her colleagues found that while the presence of the metabolic syndrome (MetS) and its individual components – central obesity, dyslipidemia, impaired fasting glucose, and hypertension – were associated with a risk of both radiographic osteoarthritis (ROA) and symptomatic OA (SxOA), all associations besides high blood pressure (particularly diastolic blood pressure) disappeared after they adjusted for body mass index (BMI) or body weight (Arthritis Rheumatol. 2017 Mar 3. doi: 10.1002/art.40087).
The research team analyzed 991 participants of the 1992-1995 Framingham Offspring Cohort who did not have existing OA at baseline. Average age was 54.2 years; 55.1% were women. According to Adult Treatment Panel III criteria, 27% of the men and 23% of the women had MetS. Those who had MetS were older, had a higher BMI, and were less likely to drink alcohol or have a college education.
In 2002-2005, the cohort underwent follow-up for the presence of OA. The incidence of ROA in the cohort was 9.8% (78 of 800 knees) in men and 10.5% (105 of 1,003 knees) in women. ROA occurred when a knee without previous radiographic evidence of OA developed a Kellgren and Lawrence score of 2 or higher, and SxOA occurred when a knee developed ROA together with knee pain.
After adjusting for age, education, smoking status, alcohol consumption, and physical activity, the researchers found that MetS, abdominal obesity, and low high-density lipoprotein cholesterol were significantly associated with incident ROA among men. Among women, abdominal obesity and high blood pressure were associated with incident ROA, while MetS was not. However, after adjustment for body weight or BMI, none of the associations remained significant.
The incidence of SxOA was 6.3% (53 of 837 knees) in men and 7.2% (75 of 1,037 knees) in women. Incident SxOA was significantly associated with MetS in women and with the MetS components of abdominal obesity and high blood pressure in both men and women before adjustment for BMI or body weight. However, only an association between diastolic blood pressure and incident SxOA persisted in both sexes after adjustment for body weight, the study authors noted.
“High blood pressure is another MetS component associated with OA in previous studies before adjusting for BMI ... While we found [diastolic blood pressure] was related to incident SxOA even after adjustment for BMI, the relation of [systolic blood pressure] and incident SxOA was nearly significant also, suggesting that both might be related to SxOA,” the study authors wrote.
But a cross-sectional analysis of the relationship would be challenging to interpret, they said, since treatment for SxOA included NSAIDs, which are known to raise blood pressure.
The National Institutes of Health supported the study. The authors declared having no conflicts of interest.
The OA incidence reported in the Framingham study is particularly noteworthy because it shows that preexisting MetS and its components are risk factors for subsequent symptomatic OA and not just radiographic OA, which seems to indicate the existence of common risk factors for both MetS and OA in a manner such that OA could be just a late-occurring component of MetS.
But it may be most appropriate to consider metabolic OA as a complication of MetS, similar to cardiovascular disease.
The fact that any component of MetS remained significantly associated with symptomatic OA after adjustment for BMI and body weight argued strongly for a metabolic driver of OA pathophysiology when considering the likely confounding of body weight between mechanical and metabolic processes.
Nevertheless, carefully designed studies are needed to determine the relative impact of increased body mass in MetS on joint loading versus metabolic derangements, including systemic inflammation, to rule in or out the effects of altered metabolism on incident OA risk independent of biomechanics.
This knowledge would help a great deal toward understanding metabolic OA and other phenotypes as well as for the development of rational treatment approaches.
Thomas Appleton, MD, PhD, of Western University in London, Ont., and his colleagues made these comments in an editorial (Arthritis Rheumatol. 2017 Mar 7. doi: 10.1002/art.40089). They declared having no conflicts of interest to relevant to their editorial.
The OA incidence reported in the Framingham study is particularly noteworthy because it shows that preexisting MetS and its components are risk factors for subsequent symptomatic OA and not just radiographic OA, which seems to indicate the existence of common risk factors for both MetS and OA in a manner such that OA could be just a late-occurring component of MetS.
But it may be most appropriate to consider metabolic OA as a complication of MetS, similar to cardiovascular disease.
The fact that any component of MetS remained significantly associated with symptomatic OA after adjustment for BMI and body weight argued strongly for a metabolic driver of OA pathophysiology when considering the likely confounding of body weight between mechanical and metabolic processes.
Nevertheless, carefully designed studies are needed to determine the relative impact of increased body mass in MetS on joint loading versus metabolic derangements, including systemic inflammation, to rule in or out the effects of altered metabolism on incident OA risk independent of biomechanics.
This knowledge would help a great deal toward understanding metabolic OA and other phenotypes as well as for the development of rational treatment approaches.
Thomas Appleton, MD, PhD, of Western University in London, Ont., and his colleagues made these comments in an editorial (Arthritis Rheumatol. 2017 Mar 7. doi: 10.1002/art.40089). They declared having no conflicts of interest to relevant to their editorial.
The OA incidence reported in the Framingham study is particularly noteworthy because it shows that preexisting MetS and its components are risk factors for subsequent symptomatic OA and not just radiographic OA, which seems to indicate the existence of common risk factors for both MetS and OA in a manner such that OA could be just a late-occurring component of MetS.
But it may be most appropriate to consider metabolic OA as a complication of MetS, similar to cardiovascular disease.
The fact that any component of MetS remained significantly associated with symptomatic OA after adjustment for BMI and body weight argued strongly for a metabolic driver of OA pathophysiology when considering the likely confounding of body weight between mechanical and metabolic processes.
Nevertheless, carefully designed studies are needed to determine the relative impact of increased body mass in MetS on joint loading versus metabolic derangements, including systemic inflammation, to rule in or out the effects of altered metabolism on incident OA risk independent of biomechanics.
This knowledge would help a great deal toward understanding metabolic OA and other phenotypes as well as for the development of rational treatment approaches.
Thomas Appleton, MD, PhD, of Western University in London, Ont., and his colleagues made these comments in an editorial (Arthritis Rheumatol. 2017 Mar 7. doi: 10.1002/art.40089). They declared having no conflicts of interest to relevant to their editorial.
The metabolic syndrome’s association with the development of osteoarthritis appears to occur primarily through the influence of factors related to body weight or body mass index, according to an analysis of data from the longitudinal Framingham osteoarthritis study.
Jingbo Niu, DSc, of the Clinical Epidemiology Research and Training Unit at Boston University, and her colleagues found that while the presence of the metabolic syndrome (MetS) and its individual components – central obesity, dyslipidemia, impaired fasting glucose, and hypertension – were associated with a risk of both radiographic osteoarthritis (ROA) and symptomatic OA (SxOA), all associations besides high blood pressure (particularly diastolic blood pressure) disappeared after they adjusted for body mass index (BMI) or body weight (Arthritis Rheumatol. 2017 Mar 3. doi: 10.1002/art.40087).
The research team analyzed 991 participants of the 1992-1995 Framingham Offspring Cohort who did not have existing OA at baseline. Average age was 54.2 years; 55.1% were women. According to Adult Treatment Panel III criteria, 27% of the men and 23% of the women had MetS. Those who had MetS were older, had a higher BMI, and were less likely to drink alcohol or have a college education.
In 2002-2005, the cohort underwent follow-up for the presence of OA. The incidence of ROA in the cohort was 9.8% (78 of 800 knees) in men and 10.5% (105 of 1,003 knees) in women. ROA occurred when a knee without previous radiographic evidence of OA developed a Kellgren and Lawrence score of 2 or higher, and SxOA occurred when a knee developed ROA together with knee pain.
After adjusting for age, education, smoking status, alcohol consumption, and physical activity, the researchers found that MetS, abdominal obesity, and low high-density lipoprotein cholesterol were significantly associated with incident ROA among men. Among women, abdominal obesity and high blood pressure were associated with incident ROA, while MetS was not. However, after adjustment for body weight or BMI, none of the associations remained significant.
The incidence of SxOA was 6.3% (53 of 837 knees) in men and 7.2% (75 of 1,037 knees) in women. Incident SxOA was significantly associated with MetS in women and with the MetS components of abdominal obesity and high blood pressure in both men and women before adjustment for BMI or body weight. However, only an association between diastolic blood pressure and incident SxOA persisted in both sexes after adjustment for body weight, the study authors noted.
“High blood pressure is another MetS component associated with OA in previous studies before adjusting for BMI ... While we found [diastolic blood pressure] was related to incident SxOA even after adjustment for BMI, the relation of [systolic blood pressure] and incident SxOA was nearly significant also, suggesting that both might be related to SxOA,” the study authors wrote.
But a cross-sectional analysis of the relationship would be challenging to interpret, they said, since treatment for SxOA included NSAIDs, which are known to raise blood pressure.
The National Institutes of Health supported the study. The authors declared having no conflicts of interest.
The metabolic syndrome’s association with the development of osteoarthritis appears to occur primarily through the influence of factors related to body weight or body mass index, according to an analysis of data from the longitudinal Framingham osteoarthritis study.
Jingbo Niu, DSc, of the Clinical Epidemiology Research and Training Unit at Boston University, and her colleagues found that while the presence of the metabolic syndrome (MetS) and its individual components – central obesity, dyslipidemia, impaired fasting glucose, and hypertension – were associated with a risk of both radiographic osteoarthritis (ROA) and symptomatic OA (SxOA), all associations besides high blood pressure (particularly diastolic blood pressure) disappeared after they adjusted for body mass index (BMI) or body weight (Arthritis Rheumatol. 2017 Mar 3. doi: 10.1002/art.40087).
The research team analyzed 991 participants of the 1992-1995 Framingham Offspring Cohort who did not have existing OA at baseline. Average age was 54.2 years; 55.1% were women. According to Adult Treatment Panel III criteria, 27% of the men and 23% of the women had MetS. Those who had MetS were older, had a higher BMI, and were less likely to drink alcohol or have a college education.
In 2002-2005, the cohort underwent follow-up for the presence of OA. The incidence of ROA in the cohort was 9.8% (78 of 800 knees) in men and 10.5% (105 of 1,003 knees) in women. ROA occurred when a knee without previous radiographic evidence of OA developed a Kellgren and Lawrence score of 2 or higher, and SxOA occurred when a knee developed ROA together with knee pain.
After adjusting for age, education, smoking status, alcohol consumption, and physical activity, the researchers found that MetS, abdominal obesity, and low high-density lipoprotein cholesterol were significantly associated with incident ROA among men. Among women, abdominal obesity and high blood pressure were associated with incident ROA, while MetS was not. However, after adjustment for body weight or BMI, none of the associations remained significant.
The incidence of SxOA was 6.3% (53 of 837 knees) in men and 7.2% (75 of 1,037 knees) in women. Incident SxOA was significantly associated with MetS in women and with the MetS components of abdominal obesity and high blood pressure in both men and women before adjustment for BMI or body weight. However, only an association between diastolic blood pressure and incident SxOA persisted in both sexes after adjustment for body weight, the study authors noted.
“High blood pressure is another MetS component associated with OA in previous studies before adjusting for BMI ... While we found [diastolic blood pressure] was related to incident SxOA even after adjustment for BMI, the relation of [systolic blood pressure] and incident SxOA was nearly significant also, suggesting that both might be related to SxOA,” the study authors wrote.
But a cross-sectional analysis of the relationship would be challenging to interpret, they said, since treatment for SxOA included NSAIDs, which are known to raise blood pressure.
The National Institutes of Health supported the study. The authors declared having no conflicts of interest.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point: There is no strong association between the metabolic syndrome (MetS) and OA after adjustment for BMI or body weight.
Major finding: Components of MetS were initially associated with incident radiographic and symptomatic OA, but after adjustment for BMI or body weight, most of the associations were weak and insignificant. However, an association between the MetS and high blood pressure persisted in both sexes.
Data source: An analysis of 991 participants of the 1992-1995 Framingham Offspring Cohort who did not have existing OA at baseline and were followed for 10 years.
Disclosures: The National Institutes of Health supported the study. The authors declared having no conflicts of interest.
No benefit found for routine inpatient rehab after knee replacement
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
FROM JAMA
Key clinical point:
Major finding: There were no significant differences in the primary outcome of a 6-minute walk test at 26 weeks or in pain, function, and quality of life measures between patients randomized to inpatient or at-home rehab protocols.
Data source: A parallel, randomized controlled trial of 165 uncomplicated knee arthroplasty patients assigned to undergo either inpatient rehab for 10 days then in-home monitored rehab for 6 weeks or to a monitored 6-week home rehab 2 weeks after surgery. The study also included a third observational group of 112 patients (87 included in analysis) who underwent at-home rehab.
Disclosures: The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
Rising arthritis prevalence driven by obesity
Rising obesity is driving an increase in arthritis prevalence, and the association is not appreciated because the impact of body mass index on joint disease is not fully understood, according to a study spanning four generations.
The proportion of people in more recent birth cohorts reporting arthritis symptoms indicates a successively greater prevalence of arthritis compared to earlier generations, based on an 18-year longitudinal study conducted by Elizabeth M. Badley, PhD, of Dalla Lana School of Public Health, University of Toronto, and her colleagues. The researchers compared the prevalence of arthritis across four birth cohorts: World War II (1935-1944; n = 1,598), older baby boomers (1945-1954; n = 2,208), younger baby boomers (1955-1964; n = 2,781) and Generation Xers (1965-1974; n = 2,230).
“Although our results do not represent projections as such, extrapolation of the trajectories of arthritis with age and comparison of the trajectories across cohorts suggest that current projections of the prevalence of arthritis … may be too low for obese individuals,” they concluded.
Using the World War II cohort as the reference group for comparison, the odds ratio for arthritis in Gen Xers was 3.2; for younger baby boomers it was 2.14; for older baby boomers, it was 1.48.
Furthermore, in all cohorts the age of onset of arthritis in obese individuals was earlier compared to those of normal weight.
“This has implications for the targeting of public health messages for the control and management of arthritis,” the researchers wrote (Arthritis Care Res. 2017. doi: 10.1002/acr.23213).
The authors noted that although the study participants were asked about arthritis in general it was likely the overall findings reflected an increasing prevalence of osteoarthritis.
And while the researchers could only speculate about the reasons for the higher prevalence of arthritis seen in recent cohorts, it was possible there had been “unrecognized changes over time in environmental or biologic exposures.”
The study was funded in part by a CIHR operating grant. No conflicts of interest were declared.
Rising obesity is driving an increase in arthritis prevalence, and the association is not appreciated because the impact of body mass index on joint disease is not fully understood, according to a study spanning four generations.
The proportion of people in more recent birth cohorts reporting arthritis symptoms indicates a successively greater prevalence of arthritis compared to earlier generations, based on an 18-year longitudinal study conducted by Elizabeth M. Badley, PhD, of Dalla Lana School of Public Health, University of Toronto, and her colleagues. The researchers compared the prevalence of arthritis across four birth cohorts: World War II (1935-1944; n = 1,598), older baby boomers (1945-1954; n = 2,208), younger baby boomers (1955-1964; n = 2,781) and Generation Xers (1965-1974; n = 2,230).
“Although our results do not represent projections as such, extrapolation of the trajectories of arthritis with age and comparison of the trajectories across cohorts suggest that current projections of the prevalence of arthritis … may be too low for obese individuals,” they concluded.
Using the World War II cohort as the reference group for comparison, the odds ratio for arthritis in Gen Xers was 3.2; for younger baby boomers it was 2.14; for older baby boomers, it was 1.48.
Furthermore, in all cohorts the age of onset of arthritis in obese individuals was earlier compared to those of normal weight.
“This has implications for the targeting of public health messages for the control and management of arthritis,” the researchers wrote (Arthritis Care Res. 2017. doi: 10.1002/acr.23213).
The authors noted that although the study participants were asked about arthritis in general it was likely the overall findings reflected an increasing prevalence of osteoarthritis.
And while the researchers could only speculate about the reasons for the higher prevalence of arthritis seen in recent cohorts, it was possible there had been “unrecognized changes over time in environmental or biologic exposures.”
The study was funded in part by a CIHR operating grant. No conflicts of interest were declared.
Rising obesity is driving an increase in arthritis prevalence, and the association is not appreciated because the impact of body mass index on joint disease is not fully understood, according to a study spanning four generations.
The proportion of people in more recent birth cohorts reporting arthritis symptoms indicates a successively greater prevalence of arthritis compared to earlier generations, based on an 18-year longitudinal study conducted by Elizabeth M. Badley, PhD, of Dalla Lana School of Public Health, University of Toronto, and her colleagues. The researchers compared the prevalence of arthritis across four birth cohorts: World War II (1935-1944; n = 1,598), older baby boomers (1945-1954; n = 2,208), younger baby boomers (1955-1964; n = 2,781) and Generation Xers (1965-1974; n = 2,230).
“Although our results do not represent projections as such, extrapolation of the trajectories of arthritis with age and comparison of the trajectories across cohorts suggest that current projections of the prevalence of arthritis … may be too low for obese individuals,” they concluded.
Using the World War II cohort as the reference group for comparison, the odds ratio for arthritis in Gen Xers was 3.2; for younger baby boomers it was 2.14; for older baby boomers, it was 1.48.
Furthermore, in all cohorts the age of onset of arthritis in obese individuals was earlier compared to those of normal weight.
“This has implications for the targeting of public health messages for the control and management of arthritis,” the researchers wrote (Arthritis Care Res. 2017. doi: 10.1002/acr.23213).
The authors noted that although the study participants were asked about arthritis in general it was likely the overall findings reflected an increasing prevalence of osteoarthritis.
And while the researchers could only speculate about the reasons for the higher prevalence of arthritis seen in recent cohorts, it was possible there had been “unrecognized changes over time in environmental or biologic exposures.”
The study was funded in part by a CIHR operating grant. No conflicts of interest were declared.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point: The prevalence of arthritis in the general population is growing and increasing obesity appears to be a factor.
Major finding: When researchers used the World War II cohort as the reference group for comparison, the odds ratio for arthritis in Gen Xers was 3.2; for younger baby boomers it was 2.14; for older baby boomers, it was 1.48.
Data source: A longitudinal analysis of data from the 1994/95 to 2010/11 National Population Health survey that included 8,817 participants in four birth cohorts.
Disclosures: The study was funded in part by a CIHR operating grant. No conflicts of interest were declared.
CDC: Greater activity limitations accompany rising arthritis prevalence
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
FROM MMWR
Key clinical point:
Major finding: About 24 million American adults report being significantly limited due to their arthritis.
Data source: 2013-2015 data from the National Health Interview Survey.
Disclosures: No disclosures were reported.
Osteoarthritis in hip or knee can increase diabetes risk
Individuals who have osteoarthritis in the hip or knee are significantly more likely to develop diabetes than are people without the condition, according to findings from a population-based cohort study.
The relationship between osteoarthritis (OA) and new-onset diabetes was largely explained by the walking limitations brought on by OA, which was unsurprising to lead author Tetyana Kendzerska, MD, PhD, of the University of Toronto, who presented the study at the annual meeting of the Canadian Rheumatology Association.
But Dr. Kendzerska noted that even though “the World Health Organization has determined that osteoarthritis is the fastest growing chronic disease and the single most common cause of disability in older adults [and] the majority of people with OA have at least one other chronic condition – usually diabetes, high blood pressure, [or] heart disease ... few studies have examined the impact of OA on these other conditions, including on the development of diabetes.”
Dr. Kendzerska and her coauthors used existing data to study a population of 16,362 adults aged 55 or older who did not have diabetes at baseline enrollment during 1996-1998 and were then followed until 2014 for a median period of 13 years. The adults’ median age was 68 years and median body mass index was 25.3 kg/m2; 61% were female. Cox regression modeling was used to quantify any association found between osteoarthritis and diabetes.
A total of 1,637 (10%) had hip osteoarthritis, 2,431 (15%) had knee osteoarthritis, and 3,908 (24%) had some type of walking limitation. Over the course of the follow-up period, 3,539 (22%) developed diabetes. The risk for diabetes was significantly elevated in particular for individuals with two hip or knee joints with OA, where the hazard ratio was 1.25 (95% CI, 1.08-1.44; P = .003) for hips and 1.16 (95% CI, 1.04-1.29; P = .008) for knees, after adjustment for baseline age, sex, income, body mass index, preexisting hypertension and cardiovascular disease, and prior primary care exposure. However, further adjustment to the comparisons for walking limitation attenuated the relationships so that they were no longer statistically significant.
The next steps for research may be to assess the impact of evidence-based osteoarthritis care on mobility and metabolic derangements, she said.
Previous “studies have been limited by a number of methodological limitations, [such as] cross-sectional design or failure to control for other factors that may explain a relationship. Our study has addressed these limitations and thus provides important evidence to suggest that osteoarthritis-related difficulty walking contributes causally to the development of diabetes [but] now we need studies to show if effective treatment of hip and knee osteoarthritis can reduce diabetes risk.”
The Canadian Institutes of Health Research funded the study. Dr. Kendzerska did not report any relevant financial disclosures.
Individuals who have osteoarthritis in the hip or knee are significantly more likely to develop diabetes than are people without the condition, according to findings from a population-based cohort study.
The relationship between osteoarthritis (OA) and new-onset diabetes was largely explained by the walking limitations brought on by OA, which was unsurprising to lead author Tetyana Kendzerska, MD, PhD, of the University of Toronto, who presented the study at the annual meeting of the Canadian Rheumatology Association.
But Dr. Kendzerska noted that even though “the World Health Organization has determined that osteoarthritis is the fastest growing chronic disease and the single most common cause of disability in older adults [and] the majority of people with OA have at least one other chronic condition – usually diabetes, high blood pressure, [or] heart disease ... few studies have examined the impact of OA on these other conditions, including on the development of diabetes.”
Dr. Kendzerska and her coauthors used existing data to study a population of 16,362 adults aged 55 or older who did not have diabetes at baseline enrollment during 1996-1998 and were then followed until 2014 for a median period of 13 years. The adults’ median age was 68 years and median body mass index was 25.3 kg/m2; 61% were female. Cox regression modeling was used to quantify any association found between osteoarthritis and diabetes.
A total of 1,637 (10%) had hip osteoarthritis, 2,431 (15%) had knee osteoarthritis, and 3,908 (24%) had some type of walking limitation. Over the course of the follow-up period, 3,539 (22%) developed diabetes. The risk for diabetes was significantly elevated in particular for individuals with two hip or knee joints with OA, where the hazard ratio was 1.25 (95% CI, 1.08-1.44; P = .003) for hips and 1.16 (95% CI, 1.04-1.29; P = .008) for knees, after adjustment for baseline age, sex, income, body mass index, preexisting hypertension and cardiovascular disease, and prior primary care exposure. However, further adjustment to the comparisons for walking limitation attenuated the relationships so that they were no longer statistically significant.
The next steps for research may be to assess the impact of evidence-based osteoarthritis care on mobility and metabolic derangements, she said.
Previous “studies have been limited by a number of methodological limitations, [such as] cross-sectional design or failure to control for other factors that may explain a relationship. Our study has addressed these limitations and thus provides important evidence to suggest that osteoarthritis-related difficulty walking contributes causally to the development of diabetes [but] now we need studies to show if effective treatment of hip and knee osteoarthritis can reduce diabetes risk.”
The Canadian Institutes of Health Research funded the study. Dr. Kendzerska did not report any relevant financial disclosures.
Individuals who have osteoarthritis in the hip or knee are significantly more likely to develop diabetes than are people without the condition, according to findings from a population-based cohort study.
The relationship between osteoarthritis (OA) and new-onset diabetes was largely explained by the walking limitations brought on by OA, which was unsurprising to lead author Tetyana Kendzerska, MD, PhD, of the University of Toronto, who presented the study at the annual meeting of the Canadian Rheumatology Association.
But Dr. Kendzerska noted that even though “the World Health Organization has determined that osteoarthritis is the fastest growing chronic disease and the single most common cause of disability in older adults [and] the majority of people with OA have at least one other chronic condition – usually diabetes, high blood pressure, [or] heart disease ... few studies have examined the impact of OA on these other conditions, including on the development of diabetes.”
Dr. Kendzerska and her coauthors used existing data to study a population of 16,362 adults aged 55 or older who did not have diabetes at baseline enrollment during 1996-1998 and were then followed until 2014 for a median period of 13 years. The adults’ median age was 68 years and median body mass index was 25.3 kg/m2; 61% were female. Cox regression modeling was used to quantify any association found between osteoarthritis and diabetes.
A total of 1,637 (10%) had hip osteoarthritis, 2,431 (15%) had knee osteoarthritis, and 3,908 (24%) had some type of walking limitation. Over the course of the follow-up period, 3,539 (22%) developed diabetes. The risk for diabetes was significantly elevated in particular for individuals with two hip or knee joints with OA, where the hazard ratio was 1.25 (95% CI, 1.08-1.44; P = .003) for hips and 1.16 (95% CI, 1.04-1.29; P = .008) for knees, after adjustment for baseline age, sex, income, body mass index, preexisting hypertension and cardiovascular disease, and prior primary care exposure. However, further adjustment to the comparisons for walking limitation attenuated the relationships so that they were no longer statistically significant.
The next steps for research may be to assess the impact of evidence-based osteoarthritis care on mobility and metabolic derangements, she said.
Previous “studies have been limited by a number of methodological limitations, [such as] cross-sectional design or failure to control for other factors that may explain a relationship. Our study has addressed these limitations and thus provides important evidence to suggest that osteoarthritis-related difficulty walking contributes causally to the development of diabetes [but] now we need studies to show if effective treatment of hip and knee osteoarthritis can reduce diabetes risk.”
The Canadian Institutes of Health Research funded the study. Dr. Kendzerska did not report any relevant financial disclosures.
FROM THE CRA SCIENTIFIC CONFERENCE
Key clinical point:
Major finding: The risk for diabetes was significantly elevated for individuals with two hip or knee joints with OA, where the hazard ratio was 1.25 (95% CI, 1.08-1.44; P = .003) for hips and 1.16 (95% CI, 1.04-1.29; P = .008) for knees.
Data source: Population-based cohort study of 16,362 individuals without diabetes at baseline.
Disclosures: The Canadian Institutes of Health Research funded the study. Dr. Kendzerska did not report any relevant financial disclosures.
Thigh muscle weakness predicts knee osteoarthritis in women only
Weakness in the lower thigh muscles is a stronger risk factor for knee osteoarthritis in women than in men, possibly because of the greater influence that high body mass index has on thigh muscle strength in women, according to new case-control study findings.
The findings, published online Feb. 8 in Arthritis Care & Research (doi: 10.1002/acr.23182), come from a study enrolling 161 patients with radiographic knee osteoarthritis and 186 controls without arthritis at baseline who were observed over a 4-year period in the ongoing multicenter Osteoarthritis Initiative cohort study. About 60% of patients and controls were women.
They found that lower muscle-specific strength in these areas significantly increased the risk of incident knee osteoarthritis in women, with odds ratios of 1.47 (95% confidence interval, 1.10-1.96) for knee flexors and 1.41 (95% CI, 1.06-1.89) for extensors. This relationship was not significant in men, and in women, the relationship lost statistical significance after adjustment for high body mass index (BMI). Lower specific strength was associated with higher BMI in women (r = –0.29, P less than .001), but not in men.
“The lower muscle-specific strength in the presence of higher BMI in women (possibly driven by greater intramuscular adiposity), but not in men, may provide a possible explanation” for the differences in knee osteoarthritis incidence in men and women with muscle strength deficits, Dr. Culvenor and colleagues wrote in their analysis.
“The response of thigh muscle to variations in BMI differed between men and women, with apparently more contractile tissue (and strength) being present in men with greater BMI, and apparently more noncontractile (adipose) tissue in women with greater BMI,” the researchers concluded.
The Osteoarthritis Initiative is cofunded by the National Institutes of Health and a consortium of pharmacological manufacturers. The work for this analysis also received funding from Paracelsus Medical University and the European Union Seventh Framework Programme. Three of the study’s seven coauthors disclosed extensive financial relationships, including employment, with Chondrometrics GmbH, a company that provides MRI analysis services, among other firms, while four disclosed no commercial conflicts.
Weakness in the lower thigh muscles is a stronger risk factor for knee osteoarthritis in women than in men, possibly because of the greater influence that high body mass index has on thigh muscle strength in women, according to new case-control study findings.
The findings, published online Feb. 8 in Arthritis Care & Research (doi: 10.1002/acr.23182), come from a study enrolling 161 patients with radiographic knee osteoarthritis and 186 controls without arthritis at baseline who were observed over a 4-year period in the ongoing multicenter Osteoarthritis Initiative cohort study. About 60% of patients and controls were women.
They found that lower muscle-specific strength in these areas significantly increased the risk of incident knee osteoarthritis in women, with odds ratios of 1.47 (95% confidence interval, 1.10-1.96) for knee flexors and 1.41 (95% CI, 1.06-1.89) for extensors. This relationship was not significant in men, and in women, the relationship lost statistical significance after adjustment for high body mass index (BMI). Lower specific strength was associated with higher BMI in women (r = –0.29, P less than .001), but not in men.
“The lower muscle-specific strength in the presence of higher BMI in women (possibly driven by greater intramuscular adiposity), but not in men, may provide a possible explanation” for the differences in knee osteoarthritis incidence in men and women with muscle strength deficits, Dr. Culvenor and colleagues wrote in their analysis.
“The response of thigh muscle to variations in BMI differed between men and women, with apparently more contractile tissue (and strength) being present in men with greater BMI, and apparently more noncontractile (adipose) tissue in women with greater BMI,” the researchers concluded.
The Osteoarthritis Initiative is cofunded by the National Institutes of Health and a consortium of pharmacological manufacturers. The work for this analysis also received funding from Paracelsus Medical University and the European Union Seventh Framework Programme. Three of the study’s seven coauthors disclosed extensive financial relationships, including employment, with Chondrometrics GmbH, a company that provides MRI analysis services, among other firms, while four disclosed no commercial conflicts.
Weakness in the lower thigh muscles is a stronger risk factor for knee osteoarthritis in women than in men, possibly because of the greater influence that high body mass index has on thigh muscle strength in women, according to new case-control study findings.
The findings, published online Feb. 8 in Arthritis Care & Research (doi: 10.1002/acr.23182), come from a study enrolling 161 patients with radiographic knee osteoarthritis and 186 controls without arthritis at baseline who were observed over a 4-year period in the ongoing multicenter Osteoarthritis Initiative cohort study. About 60% of patients and controls were women.
They found that lower muscle-specific strength in these areas significantly increased the risk of incident knee osteoarthritis in women, with odds ratios of 1.47 (95% confidence interval, 1.10-1.96) for knee flexors and 1.41 (95% CI, 1.06-1.89) for extensors. This relationship was not significant in men, and in women, the relationship lost statistical significance after adjustment for high body mass index (BMI). Lower specific strength was associated with higher BMI in women (r = –0.29, P less than .001), but not in men.
“The lower muscle-specific strength in the presence of higher BMI in women (possibly driven by greater intramuscular adiposity), but not in men, may provide a possible explanation” for the differences in knee osteoarthritis incidence in men and women with muscle strength deficits, Dr. Culvenor and colleagues wrote in their analysis.
“The response of thigh muscle to variations in BMI differed between men and women, with apparently more contractile tissue (and strength) being present in men with greater BMI, and apparently more noncontractile (adipose) tissue in women with greater BMI,” the researchers concluded.
The Osteoarthritis Initiative is cofunded by the National Institutes of Health and a consortium of pharmacological manufacturers. The work for this analysis also received funding from Paracelsus Medical University and the European Union Seventh Framework Programme. Three of the study’s seven coauthors disclosed extensive financial relationships, including employment, with Chondrometrics GmbH, a company that provides MRI analysis services, among other firms, while four disclosed no commercial conflicts.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: Weaker thigh muscle significantly increased the risk of incident knee osteoarthritis in women, but after adjusting for BMI the relationship lost significance.
Data source: Men and women (n = 161) with knee osteoarthritis and matched controls (n = 186) without osteoarthritis at baseline who were recruited from a multisite longitudinal cohort.
Disclosures: The Osteoarthritis Initiative is cofunded by the National Institutes of Health and a consortium of pharmacological manufacturers. The work for this analysis also received funding from Paracelsus Medical University and the European Union Seventh Framework Programme. Three of the study’s seven coauthors disclosed extensive financial relationships, including employment, with Chondrometrics GmbH, a company that provides MRI analysis services, among other firms, while four disclosed no commercial conflicts.