Osteoarthritis

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

Use of cannabidiol (CBD) as an add-on pain management technique in patients with either hand osteoarthritis (OA) or psoriatic arthritis (PsA) did not significantly decrease pain intensity when compared with a placebo in a randomized, double-blind trial described as the first of its kind to investigate the effect of pure CBD as an add-on analgesic therapy in patients with joint disease.

Anatoliy Sizov/Getty Images

Although data on the use of medical cannabis as a modulator of joint pain are limited, some studies suggest an effect from CBD without the addition of delta-9-tetrahydrocannabinol (THC), wrote Jonathan Vela, MD, of Aalborg (Denmark) University Hospital, and colleagues.

CBD is being used for pain conditions despite a lack of data on safety and effectiveness, the researchers emphasized. Notably, in a 2018 online survey, 62% of respondents reported using CBD for medical conditions, primarily for chronic pain and arthritis or joint pain, they wrote.

In a study published in the journal Pain, the researchers randomized 59 adults with PsA and 77 adults with hand OA to 20-30 mg of synthetic CBD or a placebo daily for 12 weeks in addition to conventional pain management. Patients initially received either oral CBD 10 mg or a placebo tablet once daily, increasing to 10 mg twice daily after 2 weeks, and once again up to 10 mg three times daily at 4 weeks if the patient did not experience more than 20-mm improvement on the visual analog scale (VAS).

The primary outcome in the trial was patient-reported pain intensity during the last 24 hours as assessed on a paper-based 100-mm VAS with the text, “How much pain have you experienced in the most symptomatic joint during the last 24 hours?” with 0 representing no pain and 100 representing the worst pain imaginable.

Overall, both CBD and placebo groups achieved significant reductions in pain intensity of 11-12 mm at 12 weeks. The mean between-group difference on the VAS was 0.23 mm (P = .96). Twenty-two percent of patients who received CBD and 21% who received placebo demonstrated a pain intensity reduction greater than 30 mm on the VAS. Pain reduction greater than 50% was reported by 17 patients (25%) in the CBD group and 16 (27%) in the placebo group. CBD had a similar effect in patients with either PsA or hand OA.

Four serious adverse events occurred during the 12-week study period, but none of these were deemed adverse drug reactions. Serious adverse events in the CBD patients included one case of ductal carcinoma and one case of lipotymia; serious adverse events in the placebo group included one case of acute shoulder fracture and one case of malignant hypertension. Fifty-nine patients reported adverse events during the study. The CBD group reported more ear-nose-throat adverse events, compared with the placebo group (8 vs. 0).

The researchers assessed the impact of CBD vs. placebo on sleep quality, depression, anxiety, or pain catastrophizing scores using the Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, and Health Assessment Questionnaire but found no differences in patients taking CBD vs. placebo.

The study findings were limited by several factors, including the potentially insufficient dose level to evoke a pain relief response, and a lack of data on additional daily use of analgesics or of the study drug beyond the prescribed dosage, the researchers noted.

The results were strengthened by the randomized, double-blind trial design and its relatively large sample size, they wrote. However, the researchers also cautioned that their study focused on CBD as a single ingredient, and the results might not generalize to other CBD formulations. They also noted that more research is needed to examine both higher doses of CBD and different types of pain disorders.

The study was supported by the Danish Psoriasis Foundation Grant and the Danish Rheumatism Foundation. The researchers had no financial conflicts to disclose.

Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m² in the diet group (P < .0001), and by –1.0 kg/m² in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”

Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m² in the diet group (P < .0001), and by –1.0 kg/m² in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”

Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

Older patients with knee osteoarthritis (OA) who underwent lengthy diet and exercise interventions reported less pain and maintained some weight loss years after the program ended, according to a new study published in Arthritis Care & Research.

AlexRaths/Getty Images

“These data imply that clinicians who treat people with knee osteoarthritis have a variety of nonpharmacologic options that preserve clinically important effects 3.5 years after the treatments end,” wrote lead author Stephen P. Messier, PhD, professor and director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C.

The study involved patients with overweight or obesity aged 55 years or older who were previously enrolled in the 1.5-year Intensive Diet and Exercise for Arthritis (IDEA) trial.

“You have to remember, this is 3.5 years after the IDEA trial ended,” Dr. Messier said in an interview. “There was no contact with them for that entire time; you’d expect, based on the literature, that they’d revert back to where they were before they entered the trial. And certainly, there was some regression, there was some weight regain, but the important part of the study is that, even after 3.5 years, and even with some weight regain, there were some clinically important effects that lasted.”

“What we feel now is that if we can somehow prepare people better for that time after they finish a weight loss intervention, from a psychological standpoint, it will make a real difference,” he added. “We are very good at helping people have the confidence to lose weight. But having the confidence to lose weight is totally different than having confidence to maintain weight loss. If we can give folks an intervention that has a psychological component, hopefully we can increase their confidence to maintain the weight loss that they attained.”
 

Study details

Of the 184 participants who were contacted for a follow-up visit, 94 consented to participate, 67% of whom were females and 88% of whom were White. A total of 27 participants had completed the diet and exercise intervention, and another 35 completed the diet-only and 32 exercise-only interventions.

In the 3.5-year period between the IDEA trial’s end and follow-up, body weight increased by 5.9 kg in the diet and exercise group (P < .0001) and by 3.1 kg in the diet-only group (P = .0006) but decreased in the exercise-only group by 1.0 kg (P = .25). However, from baseline to 5-year follow-up, all groups saw a reduction in body weight. Mean weight loss was –3.7 kg for the diet and exercise group (P = .0007), –5.8 kg for the diet group (P < .0001), and –2.9 kg for the exercise group (P = .003). Body mass index also decreased in all groups: by –1.2 kg/m2 in the diet and exercise group (P = .001), by –2.0 kg/m² in the diet group (P < .0001), and by –1.0 kg/m² in the exercise group (P = .004).

Pain – as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score – was reduced in all groups across 5-year follow-up: –1.2 (P = .03) for the diet and exercise group, –1.5 (P = .001) for the diet-only group, and –1.6 (P = .0008) for the exercise-only group. WOMAC function also significantly improved relative to baseline by 6.2 (P = .0001) in the diet and exercise group, by 6.1 (P < .0001) in the diet group, and by 3.7 (P = .01) in the exercise-only group.
 

Finding time to advise on weight loss, exercise

“If exercise and weight loss were easy, this country wouldn’t be in the state we’re in,” Tuhina Neogi, MD, PhD, of Boston University said in an interview. “Shared decision-making and personalized medicine are important; unfortunately, for the majority of physicians – particularly primary care physicians, where a good deal of OA management is undertaken – they don’t have a lot of time in their 20 minutes with a patient who has OA to counsel individuals toward a healthy weight and physical activity program when they’re also addressing common comorbidities seen in OA such as diabetes and heart disease.

“But as we know,” she added, “when you do address weight loss and physical activity, it has wide-ranging health benefits. This study provides support for utilizing formal diet and exercise programs to achieve important and durable benefits for people with OA.”

Dr. Neogi did note one of the study’s acknowledged limitations: Only slightly more than half of the contacted participants returned for follow-up. Though the authors stated that the individuals who returned were representative of both the pool of potential participants and the IDEA cohort as a whole, “we don’t want to make too many inferences when you don’t have the whole study population available,” she said. “The people who have agreed to come back 3.5 years later for follow-up testing, maybe they are a little more health conscious, more resilient. Those people might be systematically different than the people who [did not return], even though most of the factors were not statistically different between the groups.

“Whatever positive attributes they may have, though, we need to understand more about them,” she added. “We need to know how they maintained the benefits they had 3.5 years prior. That kind of understanding is important to inform long-term strategies in OA management.”

Dr. Messier highlighted a related, ongoing study he’s leading in which more than 800 overweight patients in North Carolina who suffer from knee pain are being led through diet and exercise interventions in a community setting. The goal is to replicate the IDEA results outside of a clinical trial setting and show skeptical physicians that diet and exercise can be enacted and maintained in this subset of patients.

“I think we know how effective weight loss is, especially when combined with exercise, in reducing pain, improving function, improving quality of life in these patients,” he said. “The next step is to allow them to maintain those benefits for a long period of time after the intervention ends.”

The study was supported by grants from the National Institutes of Health and by General Nutrition Centers. Its authors reported no potential conflicts of interest.

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.

While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.

In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.

While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.

In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.

While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.

In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

Is innervation of cartilage the driving force behind development of osteoarthritis and subsequent pain, or is the degeneration of joints in osteoarthritis affecting nerves and creating pain?

This was the question underpinning a fascinating debate at the OARSI 2021 World Congress, featuring two giants of the OA research community: Anne-Marie Malfait, MD, PhD, professor of medicine in the division of rheumatology at Rush Medical College, Chicago, and Stefan Lohmander, MD, PhD, professor emeritus of orthopedics at Lund (Sweden) University in Sweden.

At stake in the discussion is a greater understanding of the physiological processes that underpin both the development of OA in joints and the experience of pain in patients with OA.

Dr. Lohmander started by pointing out that, while pain is the primary symptoms of OA, it does not always overlap with the physiological processes of the disease, as measured by techniques such as MRI, x-ray, biomarkers, and gait analysis.

“This lack of complete overlap is often a problem when doing our clinical trials,” Dr. Lohmander told the conference, sponsored by Osteoarthritis Research Society International. “When talking about osteoarthritis, we also need to remind ourselves every so often that we are speaking of either the symptoms or the disease and maybe not always the both of them.”

While a healthy joint has pain receptors everywhere but the cartilage, studies have found that the osteoarthritic joint brings blood vessels, sensory nerves, and cells expressing nerve growth factor from the subchondral bone into even noncalcified articular cartilage, he said.

These nociceptor neurons are mechanosensitive, so mechanical injury to the joint triggers inflammation, and the inflammatory proteins themselves act on the nociceptors to generate pain signals in the brain, “so clearly, it is the joint that signals the brain,” Dr. Lohmander said.

However, Dr. Malfait pointed out that there is a body of evidence from animal studies showing that the absence of sensory nerves in joints – either from disease or removal – is associated with the onset or worsening of OA.

“Healthy nerves are really important to ensure healthy joints,” Dr. Malfait said. She said age-related loss of sensory nerves always preceded age-related OA, and was also associated with age-related loss of proprioception and vibratory perception.

Interestingly, animal studies suggest that removing intra-articular nociceptors can actually have a protective effect on the osteoarthritic joint, Dr. Malfait said. Studies in humans who have experienced neurologic lesions also suggests improvement in conditions such as rheumatoid arthritis.

She raised the idea of neurogenic inflammation: that peripheral neurons are releasing vasoactive mediators that contribute to inflammation in tissues. “These nerves and nerve products are talking to all the different cells in the joints,” she said.

Defending his argument that joint pathology is the cause of pain, not the pain causing the joint pathology, Dr. Lohmander gave the example of studies that looked at radiographic abnormalities between two knees of the same patient who also had discordant pain measures for each knee. This research “showed strong association between radiographic osteoarthritis and knee pain, supporting the argument that structural abnormalities cause knee pain,” he said.

Martin van der Esch, PhD, of the Amsterdam University of Applied Sciences, said the debate was one of the highlights of the conference because it addressed such an important and longstanding question in OA.

“Is osteoarthritis leading to a generalized pain, so involvement of the nervous system, but the source – the causality – is in the joint?” he said in an interview. “Or is it the other way around, so that means is there first a problem inside the nervous system – including also the vascular system – and which is presented in the joint?”

It is more than an academic discussion because the conclusions of that could mean different treatment approaches are needed for different groups of patients, and raises the different ways of thinking about OA, he said.

None of the sources for this story declared having any relevant conflicts of interest.

Is innervation of cartilage the driving force behind development of osteoarthritis and subsequent pain, or is the degeneration of joints in osteoarthritis affecting nerves and creating pain?

This was the question underpinning a fascinating debate at the OARSI 2021 World Congress, featuring two giants of the OA research community: Anne-Marie Malfait, MD, PhD, professor of medicine in the division of rheumatology at Rush Medical College, Chicago, and Stefan Lohmander, MD, PhD, professor emeritus of orthopedics at Lund (Sweden) University in Sweden.

At stake in the discussion is a greater understanding of the physiological processes that underpin both the development of OA in joints and the experience of pain in patients with OA.

Dr. Lohmander started by pointing out that, while pain is the primary symptoms of OA, it does not always overlap with the physiological processes of the disease, as measured by techniques such as MRI, x-ray, biomarkers, and gait analysis.

“This lack of complete overlap is often a problem when doing our clinical trials,” Dr. Lohmander told the conference, sponsored by Osteoarthritis Research Society International. “When talking about osteoarthritis, we also need to remind ourselves every so often that we are speaking of either the symptoms or the disease and maybe not always the both of them.”

While a healthy joint has pain receptors everywhere but the cartilage, studies have found that the osteoarthritic joint brings blood vessels, sensory nerves, and cells expressing nerve growth factor from the subchondral bone into even noncalcified articular cartilage, he said.

These nociceptor neurons are mechanosensitive, so mechanical injury to the joint triggers inflammation, and the inflammatory proteins themselves act on the nociceptors to generate pain signals in the brain, “so clearly, it is the joint that signals the brain,” Dr. Lohmander said.

However, Dr. Malfait pointed out that there is a body of evidence from animal studies showing that the absence of sensory nerves in joints – either from disease or removal – is associated with the onset or worsening of OA.

“Healthy nerves are really important to ensure healthy joints,” Dr. Malfait said. She said age-related loss of sensory nerves always preceded age-related OA, and was also associated with age-related loss of proprioception and vibratory perception.

Interestingly, animal studies suggest that removing intra-articular nociceptors can actually have a protective effect on the osteoarthritic joint, Dr. Malfait said. Studies in humans who have experienced neurologic lesions also suggests improvement in conditions such as rheumatoid arthritis.

She raised the idea of neurogenic inflammation: that peripheral neurons are releasing vasoactive mediators that contribute to inflammation in tissues. “These nerves and nerve products are talking to all the different cells in the joints,” she said.

Defending his argument that joint pathology is the cause of pain, not the pain causing the joint pathology, Dr. Lohmander gave the example of studies that looked at radiographic abnormalities between two knees of the same patient who also had discordant pain measures for each knee. This research “showed strong association between radiographic osteoarthritis and knee pain, supporting the argument that structural abnormalities cause knee pain,” he said.

Martin van der Esch, PhD, of the Amsterdam University of Applied Sciences, said the debate was one of the highlights of the conference because it addressed such an important and longstanding question in OA.

“Is osteoarthritis leading to a generalized pain, so involvement of the nervous system, but the source – the causality – is in the joint?” he said in an interview. “Or is it the other way around, so that means is there first a problem inside the nervous system – including also the vascular system – and which is presented in the joint?”

It is more than an academic discussion because the conclusions of that could mean different treatment approaches are needed for different groups of patients, and raises the different ways of thinking about OA, he said.

None of the sources for this story declared having any relevant conflicts of interest.

Is innervation of cartilage the driving force behind development of osteoarthritis and subsequent pain, or is the degeneration of joints in osteoarthritis affecting nerves and creating pain?

This was the question underpinning a fascinating debate at the OARSI 2021 World Congress, featuring two giants of the OA research community: Anne-Marie Malfait, MD, PhD, professor of medicine in the division of rheumatology at Rush Medical College, Chicago, and Stefan Lohmander, MD, PhD, professor emeritus of orthopedics at Lund (Sweden) University in Sweden.

At stake in the discussion is a greater understanding of the physiological processes that underpin both the development of OA in joints and the experience of pain in patients with OA.

Dr. Lohmander started by pointing out that, while pain is the primary symptoms of OA, it does not always overlap with the physiological processes of the disease, as measured by techniques such as MRI, x-ray, biomarkers, and gait analysis.

“This lack of complete overlap is often a problem when doing our clinical trials,” Dr. Lohmander told the conference, sponsored by Osteoarthritis Research Society International. “When talking about osteoarthritis, we also need to remind ourselves every so often that we are speaking of either the symptoms or the disease and maybe not always the both of them.”

While a healthy joint has pain receptors everywhere but the cartilage, studies have found that the osteoarthritic joint brings blood vessels, sensory nerves, and cells expressing nerve growth factor from the subchondral bone into even noncalcified articular cartilage, he said.

These nociceptor neurons are mechanosensitive, so mechanical injury to the joint triggers inflammation, and the inflammatory proteins themselves act on the nociceptors to generate pain signals in the brain, “so clearly, it is the joint that signals the brain,” Dr. Lohmander said.

However, Dr. Malfait pointed out that there is a body of evidence from animal studies showing that the absence of sensory nerves in joints – either from disease or removal – is associated with the onset or worsening of OA.

“Healthy nerves are really important to ensure healthy joints,” Dr. Malfait said. She said age-related loss of sensory nerves always preceded age-related OA, and was also associated with age-related loss of proprioception and vibratory perception.

Interestingly, animal studies suggest that removing intra-articular nociceptors can actually have a protective effect on the osteoarthritic joint, Dr. Malfait said. Studies in humans who have experienced neurologic lesions also suggests improvement in conditions such as rheumatoid arthritis.

She raised the idea of neurogenic inflammation: that peripheral neurons are releasing vasoactive mediators that contribute to inflammation in tissues. “These nerves and nerve products are talking to all the different cells in the joints,” she said.

Defending his argument that joint pathology is the cause of pain, not the pain causing the joint pathology, Dr. Lohmander gave the example of studies that looked at radiographic abnormalities between two knees of the same patient who also had discordant pain measures for each knee. This research “showed strong association between radiographic osteoarthritis and knee pain, supporting the argument that structural abnormalities cause knee pain,” he said.

Martin van der Esch, PhD, of the Amsterdam University of Applied Sciences, said the debate was one of the highlights of the conference because it addressed such an important and longstanding question in OA.

“Is osteoarthritis leading to a generalized pain, so involvement of the nervous system, but the source – the causality – is in the joint?” he said in an interview. “Or is it the other way around, so that means is there first a problem inside the nervous system – including also the vascular system – and which is presented in the joint?”

It is more than an academic discussion because the conclusions of that could mean different treatment approaches are needed for different groups of patients, and raises the different ways of thinking about OA, he said.

None of the sources for this story declared having any relevant conflicts of interest.

Wearing stable, supportive footwear reduces knee pain to a significantly greater extent than what’s felt with flat, flexible shoes in patients with severe knee osteoarthritis, according to results of a randomized, controlled trial presented at the OARSI 2021 World Congress.

Stockbyte/Thinkstock

Clinical guidelines for knee OA emphasize the importance of patients self-managing their condition with exercise, weight control, and appropriate footwear. However, there is limited evidence on which footwear is best, and some guidelines advocate stable supportive shoes based solely on expert opinion, Kade Paterson, PhD, of the University of Melbourne told the conference, sponsored by Osteoarthritis Research Society International.

“Recent research suggests that another type of shoe style – termed flat, flexible shoes – may be more beneficial,” Dr. Paterson said, citing a randomized, controlled trial that found greater improvement in pain and function with flat flexible shoes, compared with neutral tennis shoes. “Flat, flexible shoes are generally lighter, and have thinner, more flexible soles.”

In this study, which was published earlier this year in Annals of Internal Medicine, 164 individuals with knee OA who had experienced knee pain on most days of the past month were randomized to wear either stable, supportive shoes or flat, flexible shoes for at least 6 hours a day for 6 months. Six of each shoe type – three male styles and three female styles – were offered, having been chosen based on a survey in which participants were asked about a selection of commercially available shoes they were most likely to wear.

Researchers found participants who wore the stable, supportive shoes had significantly greater reductions in knee pain on walking during the previous week, representing a mean difference of 1.1 units on an 11-point numerical rating scale. More patients in the stable, supportive shoe arm of the study achieved minimal clinically important difference in pain than did those in the flat, flexible shoe group.

Stable, supportive shoes were also associated with greater improvements in knee-related quality of life scores and greater improvements in overall pain. However, there was no significant difference between the two groups in function. Patients wearing flat, flexible shoes reported significantly more adverse events – mainly onset of or increases in knee pain.

Dr. Paterson said the results were surprising, given previous research suggesting a benefit from lighter flat, flexible shoes. “Some previous research showed that those shoes reduced knee joint forces that were associated with pain and reduced it more than stable, supportive shoes, and based on the biomechanical research, we thought would be flat, flexible shoes,” he said in an interview.

Another observation to come from the study was the poor quality of most patients’ everyday shoes. Dr. Paterson said that most of the participants’ usual shoes were very old, and many were also wearing inappropriate footwear for knee OA, including shoes with heels or slippers.

“We would strongly recommend that clinicians ask patients to even bring in their most commonly worn shoes and then recommend new shoes, and based on our data, certainly stable supportive shoes,” he said.

Commenting on the findings, Jos Runhaar, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, said this study provided high-quality evidence for this specific intervention in this specific group of patients, namely those with more severe, end-stage OA who had long-lasting changes in their foot posture and gait.

“Based on this, I would say that restoring the original posture of the foot – because that’s how the stable, supportive shoes are probably designed – is more beneficial than actually supporting the natural gait that people are already adapted to at that stage,” Dr. Runhaar said in an interview.

Dr. Paterson noted that the findings of the study were not generalizable to people with mild knee OA, and also that the study did not compare either shoe type with participants’ usual shoes.

The study and three authors were supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

Wearing stable, supportive footwear reduces knee pain to a significantly greater extent than what’s felt with flat, flexible shoes in patients with severe knee osteoarthritis, according to results of a randomized, controlled trial presented at the OARSI 2021 World Congress.

Stockbyte/Thinkstock

Clinical guidelines for knee OA emphasize the importance of patients self-managing their condition with exercise, weight control, and appropriate footwear. However, there is limited evidence on which footwear is best, and some guidelines advocate stable supportive shoes based solely on expert opinion, Kade Paterson, PhD, of the University of Melbourne told the conference, sponsored by Osteoarthritis Research Society International.

“Recent research suggests that another type of shoe style – termed flat, flexible shoes – may be more beneficial,” Dr. Paterson said, citing a randomized, controlled trial that found greater improvement in pain and function with flat flexible shoes, compared with neutral tennis shoes. “Flat, flexible shoes are generally lighter, and have thinner, more flexible soles.”

In this study, which was published earlier this year in Annals of Internal Medicine, 164 individuals with knee OA who had experienced knee pain on most days of the past month were randomized to wear either stable, supportive shoes or flat, flexible shoes for at least 6 hours a day for 6 months. Six of each shoe type – three male styles and three female styles – were offered, having been chosen based on a survey in which participants were asked about a selection of commercially available shoes they were most likely to wear.

Researchers found participants who wore the stable, supportive shoes had significantly greater reductions in knee pain on walking during the previous week, representing a mean difference of 1.1 units on an 11-point numerical rating scale. More patients in the stable, supportive shoe arm of the study achieved minimal clinically important difference in pain than did those in the flat, flexible shoe group.

Stable, supportive shoes were also associated with greater improvements in knee-related quality of life scores and greater improvements in overall pain. However, there was no significant difference between the two groups in function. Patients wearing flat, flexible shoes reported significantly more adverse events – mainly onset of or increases in knee pain.

Dr. Paterson said the results were surprising, given previous research suggesting a benefit from lighter flat, flexible shoes. “Some previous research showed that those shoes reduced knee joint forces that were associated with pain and reduced it more than stable, supportive shoes, and based on the biomechanical research, we thought would be flat, flexible shoes,” he said in an interview.

Another observation to come from the study was the poor quality of most patients’ everyday shoes. Dr. Paterson said that most of the participants’ usual shoes were very old, and many were also wearing inappropriate footwear for knee OA, including shoes with heels or slippers.

“We would strongly recommend that clinicians ask patients to even bring in their most commonly worn shoes and then recommend new shoes, and based on our data, certainly stable supportive shoes,” he said.

Commenting on the findings, Jos Runhaar, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, said this study provided high-quality evidence for this specific intervention in this specific group of patients, namely those with more severe, end-stage OA who had long-lasting changes in their foot posture and gait.

“Based on this, I would say that restoring the original posture of the foot – because that’s how the stable, supportive shoes are probably designed – is more beneficial than actually supporting the natural gait that people are already adapted to at that stage,” Dr. Runhaar said in an interview.

Dr. Paterson noted that the findings of the study were not generalizable to people with mild knee OA, and also that the study did not compare either shoe type with participants’ usual shoes.

The study and three authors were supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

Wearing stable, supportive footwear reduces knee pain to a significantly greater extent than what’s felt with flat, flexible shoes in patients with severe knee osteoarthritis, according to results of a randomized, controlled trial presented at the OARSI 2021 World Congress.

Stockbyte/Thinkstock

Clinical guidelines for knee OA emphasize the importance of patients self-managing their condition with exercise, weight control, and appropriate footwear. However, there is limited evidence on which footwear is best, and some guidelines advocate stable supportive shoes based solely on expert opinion, Kade Paterson, PhD, of the University of Melbourne told the conference, sponsored by Osteoarthritis Research Society International.

“Recent research suggests that another type of shoe style – termed flat, flexible shoes – may be more beneficial,” Dr. Paterson said, citing a randomized, controlled trial that found greater improvement in pain and function with flat flexible shoes, compared with neutral tennis shoes. “Flat, flexible shoes are generally lighter, and have thinner, more flexible soles.”

In this study, which was published earlier this year in Annals of Internal Medicine, 164 individuals with knee OA who had experienced knee pain on most days of the past month were randomized to wear either stable, supportive shoes or flat, flexible shoes for at least 6 hours a day for 6 months. Six of each shoe type – three male styles and three female styles – were offered, having been chosen based on a survey in which participants were asked about a selection of commercially available shoes they were most likely to wear.

Researchers found participants who wore the stable, supportive shoes had significantly greater reductions in knee pain on walking during the previous week, representing a mean difference of 1.1 units on an 11-point numerical rating scale. More patients in the stable, supportive shoe arm of the study achieved minimal clinically important difference in pain than did those in the flat, flexible shoe group.

Stable, supportive shoes were also associated with greater improvements in knee-related quality of life scores and greater improvements in overall pain. However, there was no significant difference between the two groups in function. Patients wearing flat, flexible shoes reported significantly more adverse events – mainly onset of or increases in knee pain.

Dr. Paterson said the results were surprising, given previous research suggesting a benefit from lighter flat, flexible shoes. “Some previous research showed that those shoes reduced knee joint forces that were associated with pain and reduced it more than stable, supportive shoes, and based on the biomechanical research, we thought would be flat, flexible shoes,” he said in an interview.

Another observation to come from the study was the poor quality of most patients’ everyday shoes. Dr. Paterson said that most of the participants’ usual shoes were very old, and many were also wearing inappropriate footwear for knee OA, including shoes with heels or slippers.

“We would strongly recommend that clinicians ask patients to even bring in their most commonly worn shoes and then recommend new shoes, and based on our data, certainly stable supportive shoes,” he said.

Commenting on the findings, Jos Runhaar, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, said this study provided high-quality evidence for this specific intervention in this specific group of patients, namely those with more severe, end-stage OA who had long-lasting changes in their foot posture and gait.

“Based on this, I would say that restoring the original posture of the foot – because that’s how the stable, supportive shoes are probably designed – is more beneficial than actually supporting the natural gait that people are already adapted to at that stage,” Dr. Runhaar said in an interview.

Dr. Paterson noted that the findings of the study were not generalizable to people with mild knee OA, and also that the study did not compare either shoe type with participants’ usual shoes.

The study and three authors were supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.

The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.

“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m² or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.

“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.