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Adalimumab strikes out for aortic inflammation in psoriasis
ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.
a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.
The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).
Both studies used positron emission tomography/computed tomography to assess vascular inflammation.
“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).
Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.
In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”
Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.
Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.
At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.
Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.
About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.
The work was funded by the National Institutes of Health and AbbVie, adalimumab’s maker. Among many industry ties, Dr. Gelfand is a consultant for Janssen, maker of ustekinumab, and receives research grants from Janssen and AbbVie.
SOURCE: Gelfand JM et al. IID 2018, Abstract 393.
ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.
a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.
The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).
Both studies used positron emission tomography/computed tomography to assess vascular inflammation.
“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).
Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.
In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”
Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.
Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.
At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.
Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.
About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.
The work was funded by the National Institutes of Health and AbbVie, adalimumab’s maker. Among many industry ties, Dr. Gelfand is a consultant for Janssen, maker of ustekinumab, and receives research grants from Janssen and AbbVie.
SOURCE: Gelfand JM et al. IID 2018, Abstract 393.
ORLANDO – Adalimumab (Humira) did not reduce aortic inflammation in a year-long, randomized trial that pitted the tumor necrosis factor (TNF) blocker against phototherapy and placebo in 97 psoriasis patients.
a risk factor for cardiovascular events, said senior investigator Joel M. Gelfand, MD, a dermatology professor at the University of Pennsylvania, Philadelphia.
The other trial, from Canada, also found no effect in the ascending aorta after 52 weeks of treatment, but it did find a modest increase in carotid inflammation (J Invest Dermatol. 2017 Aug;137[8]:1638-45).
Both studies used positron emission tomography/computed tomography to assess vascular inflammation.
“We know patients with psoriasis are at increased risk for cardiovascular disease. We think the same kind of inflammation that occurs in atherosclerosis occurs in psoriasis, but we are still teasing out the impact of therapy and which one is most likely to lower the risk of heart attacks, strokes, and things of that nature,” Dr. Gelfand said at the International Investigative Dermatology meeting. The study was published when he gave his presentation (Circ Cardiovasc Imaging. 2018 Jun. doi: 10.1161/CIRCIMAGING.117.007394).
Although it didn’t reduce aortic inflammation, adalimumab had a positive effect on glycoprotein acetylation, a marker of inflammation and subclinical cardiovascular disease in psoriasis. Observational studies have also reported a drop in cardiovascular events with adalimumab. Taken together, the mixed findings “give us pause for thought,” Dr. Gelfand said.
In a previous trial, he and his colleagues had found that the interleukin blocker ustekinumab (Stelara) reduced aortic inflammation in psoriasis by about 19%, but Dr. Gelfand said at the meeting that it’s too early to opt for ustekinumab over adalimumab for cardiovascular protection: “I don’t think we are quite there yet; we are still not certain.”
Following washout of psoriasis treatments, the 97 subjects were randomized to either adalimumab for 12 months or ultraviolet B phototherapy or placebo for 12 weeks, followed by adalimumab for 12 months.
Aortic inflammation was used as a proxy for cardiovascular events because trials to assess actual event rates would require thousands of patients treated for several years. “They’re not likely to be done in psoriasis any time soon,” Dr. Gelfand said.
At both 12 and 52 weeks, adalimumab patients had no change in aortic inflammation, compared with placebo and baseline. Phototherapy patients had a 4% drop from baseline at 12 weeks, but it was not statistically significant when compared with placebo.
Both adalimumab and phototherapy decreased systemic inflammation as gauged by serum C-reactive protein and interleukin-6 levels, but only adalimumab reduced TNF levels and glycoprotein acetylation at 12 and 52 weeks. Neither treatment affected insulin, adiponectin, or leptin levels. Adalimumab dropped HDL cholesterol a bit, a known side effect, while phototherapy increased it.
About half of the patients in both treatment arms had a 75% reduction in the Psoriasis Area and Severity Index at 12 weeks, compared with 7% of those on placebo. Subjects were aged 43 years, on average, and more than two-thirds were men. They had a mean psoriasis duration of 17 years and a baseline PASI score of 19.
The work was funded by the National Institutes of Health and AbbVie, adalimumab’s maker. Among many industry ties, Dr. Gelfand is a consultant for Janssen, maker of ustekinumab, and receives research grants from Janssen and AbbVie.
SOURCE: Gelfand JM et al. IID 2018, Abstract 393.
REPORTING FROM IID 2018
Key clinical point: Adalimumab does not appear to reduce aortic inflammation in psoriasis, a risk factor for cardiovascular events.
Major finding: After a year of treatment, patients had no change in aortic inflammation, compared with placebo and baseline.
Study details: Randomized, controlled trial of 97 patients
Disclosures: The National Institutes of Health and AbbVie, adalimumab’s maker, funded the work. Among many industry ties, Dr. Gelfand is a consultant for Janssen, maker of ustekinumab, and receives research grants from Janssen and AbbVie.
Source: Gelfand JM et al. IID 2018, abstract 393
Checkpoint inhibitors in autoimmune disease: More flares, better cancer outcomes
AMSTERDAM – In patients with autoimmune diseases, cancer treatment with checkpoint inhibitor immunotherapy increases the risk of flares, but these flares are associated with improved cancer outcomes, according to a multicenter, retrospective study presented at the European Congress of Rheumatology.
“Survival was longer in patients who experienced a flare of their preexisting autoimmune disease or any other immune-related adverse event, but this gain was lost if an immunosuppressive therapy was used,” reported Alice Tison, a resident in rheumatology at the Centre Hospitalier Universitaire, Brest, France.
These were some of the mixed messages from this evaluation, which involved 112 patients with preexisting autoimmune disease (PAD) whose data were collected from 11 tertiary care centers in France. Of the cases of PAD represented, the majority involved joint diseases, including psoriatic arthritis (28%), rheumatoid arthritis (18%), and spondyloarthritis (4.5%). However, other types of PAD, including inflammatory bowel disease (13%), were included in the series.
Only 33% of the patients had active disease at the time that checkpoint inhibitor therapy was initiated, and only 21% were taking an immunosuppressive therapy for their disease. Of those on therapy, the majority were taking steroids, but about a third of those on therapy were taking a disease-modifying antirheumatic drug, such as methotrexate.
With the initiation of checkpoint inhibitors, which were offered primarily for the treatment of melanoma (59%) and non–small cell lung cancer (36%), 42% of patients with PAD developed a disease flare. Of these, 30% were considered severe. Other immune-related events not considered related to the underlying disease, such as colitis, were also observed but at rates not clearly different than those observed in patients without PAD.
The activity of checkpoint inhibitors did not appear to be different than that observed in non-PAD patients. For example, the overall response rate was 48% in those with melanoma and 54% in those with non–small cell lung cancer. After a median of 8 months of follow-up, the median progression-free survival was 12.4 months and 9.7 months for the two diseases, respectively. Median overall survival had not been reached in either disease.
However, those with a flare or another immune-related adverse event had significantly better progression-free survival (P = .016) and overall survival (P = .004) when compared with those who did not flare or have an immune-related adverse event. According to Ms. Tison, this has been reported before, but a more surprising finding was that the gain in progression-free survival and overall survival was lost in those treated with an immunosuppressive drug.
Even though non-PAD patients commonly receive steroids for immune-related adverse events such as colitis, the loss of benefit in PAD patients who received immunosuppressive therapies may be caused by, at least in part, cross-reactivity between tumor antigens and autoantigens, Ms. Tison speculated.
Ms. Tison was cautious in drawing conclusions about specific strategies to optimize benefits from checkpoint inhibitors in PAD based on this limited series of patients. However, she did suggest that discontinuation of immunosuppressive therapies prior to initiating checkpoint inhibitors may be prudent in PAD patients, particularly those with inactive disease.
Overall, she emphasized that checkpoint inhibitors “have revolutionized the management of several cancers” and should not be denied to PAD patients who are otherwise appropriate candidates. Although flares are common, more than half of PAD patients in this series did not flare and flares were mild to moderate in most of those who did.
“The response to checkpoint inhibitors in PAD patients is good,” Ms. Tison advised. For those who do flare, “we need prospective studies to understand which strategies provide a good balance of benefit to risk” for cancer immunotherapy and for the options to manage immune-related adverse events.
The study was not industry funded. Ms. Tison reported no potential conflicts of interest.
SOURCE: Tison A et al. Ann Rheum Dis. 2018;77(Suppl 2):147. EULAR Congress 2018, Abstract OP0196.
AMSTERDAM – In patients with autoimmune diseases, cancer treatment with checkpoint inhibitor immunotherapy increases the risk of flares, but these flares are associated with improved cancer outcomes, according to a multicenter, retrospective study presented at the European Congress of Rheumatology.
“Survival was longer in patients who experienced a flare of their preexisting autoimmune disease or any other immune-related adverse event, but this gain was lost if an immunosuppressive therapy was used,” reported Alice Tison, a resident in rheumatology at the Centre Hospitalier Universitaire, Brest, France.
These were some of the mixed messages from this evaluation, which involved 112 patients with preexisting autoimmune disease (PAD) whose data were collected from 11 tertiary care centers in France. Of the cases of PAD represented, the majority involved joint diseases, including psoriatic arthritis (28%), rheumatoid arthritis (18%), and spondyloarthritis (4.5%). However, other types of PAD, including inflammatory bowel disease (13%), were included in the series.
Only 33% of the patients had active disease at the time that checkpoint inhibitor therapy was initiated, and only 21% were taking an immunosuppressive therapy for their disease. Of those on therapy, the majority were taking steroids, but about a third of those on therapy were taking a disease-modifying antirheumatic drug, such as methotrexate.
With the initiation of checkpoint inhibitors, which were offered primarily for the treatment of melanoma (59%) and non–small cell lung cancer (36%), 42% of patients with PAD developed a disease flare. Of these, 30% were considered severe. Other immune-related events not considered related to the underlying disease, such as colitis, were also observed but at rates not clearly different than those observed in patients without PAD.
The activity of checkpoint inhibitors did not appear to be different than that observed in non-PAD patients. For example, the overall response rate was 48% in those with melanoma and 54% in those with non–small cell lung cancer. After a median of 8 months of follow-up, the median progression-free survival was 12.4 months and 9.7 months for the two diseases, respectively. Median overall survival had not been reached in either disease.
However, those with a flare or another immune-related adverse event had significantly better progression-free survival (P = .016) and overall survival (P = .004) when compared with those who did not flare or have an immune-related adverse event. According to Ms. Tison, this has been reported before, but a more surprising finding was that the gain in progression-free survival and overall survival was lost in those treated with an immunosuppressive drug.
Even though non-PAD patients commonly receive steroids for immune-related adverse events such as colitis, the loss of benefit in PAD patients who received immunosuppressive therapies may be caused by, at least in part, cross-reactivity between tumor antigens and autoantigens, Ms. Tison speculated.
Ms. Tison was cautious in drawing conclusions about specific strategies to optimize benefits from checkpoint inhibitors in PAD based on this limited series of patients. However, she did suggest that discontinuation of immunosuppressive therapies prior to initiating checkpoint inhibitors may be prudent in PAD patients, particularly those with inactive disease.
Overall, she emphasized that checkpoint inhibitors “have revolutionized the management of several cancers” and should not be denied to PAD patients who are otherwise appropriate candidates. Although flares are common, more than half of PAD patients in this series did not flare and flares were mild to moderate in most of those who did.
“The response to checkpoint inhibitors in PAD patients is good,” Ms. Tison advised. For those who do flare, “we need prospective studies to understand which strategies provide a good balance of benefit to risk” for cancer immunotherapy and for the options to manage immune-related adverse events.
The study was not industry funded. Ms. Tison reported no potential conflicts of interest.
SOURCE: Tison A et al. Ann Rheum Dis. 2018;77(Suppl 2):147. EULAR Congress 2018, Abstract OP0196.
AMSTERDAM – In patients with autoimmune diseases, cancer treatment with checkpoint inhibitor immunotherapy increases the risk of flares, but these flares are associated with improved cancer outcomes, according to a multicenter, retrospective study presented at the European Congress of Rheumatology.
“Survival was longer in patients who experienced a flare of their preexisting autoimmune disease or any other immune-related adverse event, but this gain was lost if an immunosuppressive therapy was used,” reported Alice Tison, a resident in rheumatology at the Centre Hospitalier Universitaire, Brest, France.
These were some of the mixed messages from this evaluation, which involved 112 patients with preexisting autoimmune disease (PAD) whose data were collected from 11 tertiary care centers in France. Of the cases of PAD represented, the majority involved joint diseases, including psoriatic arthritis (28%), rheumatoid arthritis (18%), and spondyloarthritis (4.5%). However, other types of PAD, including inflammatory bowel disease (13%), were included in the series.
Only 33% of the patients had active disease at the time that checkpoint inhibitor therapy was initiated, and only 21% were taking an immunosuppressive therapy for their disease. Of those on therapy, the majority were taking steroids, but about a third of those on therapy were taking a disease-modifying antirheumatic drug, such as methotrexate.
With the initiation of checkpoint inhibitors, which were offered primarily for the treatment of melanoma (59%) and non–small cell lung cancer (36%), 42% of patients with PAD developed a disease flare. Of these, 30% were considered severe. Other immune-related events not considered related to the underlying disease, such as colitis, were also observed but at rates not clearly different than those observed in patients without PAD.
The activity of checkpoint inhibitors did not appear to be different than that observed in non-PAD patients. For example, the overall response rate was 48% in those with melanoma and 54% in those with non–small cell lung cancer. After a median of 8 months of follow-up, the median progression-free survival was 12.4 months and 9.7 months for the two diseases, respectively. Median overall survival had not been reached in either disease.
However, those with a flare or another immune-related adverse event had significantly better progression-free survival (P = .016) and overall survival (P = .004) when compared with those who did not flare or have an immune-related adverse event. According to Ms. Tison, this has been reported before, but a more surprising finding was that the gain in progression-free survival and overall survival was lost in those treated with an immunosuppressive drug.
Even though non-PAD patients commonly receive steroids for immune-related adverse events such as colitis, the loss of benefit in PAD patients who received immunosuppressive therapies may be caused by, at least in part, cross-reactivity between tumor antigens and autoantigens, Ms. Tison speculated.
Ms. Tison was cautious in drawing conclusions about specific strategies to optimize benefits from checkpoint inhibitors in PAD based on this limited series of patients. However, she did suggest that discontinuation of immunosuppressive therapies prior to initiating checkpoint inhibitors may be prudent in PAD patients, particularly those with inactive disease.
Overall, she emphasized that checkpoint inhibitors “have revolutionized the management of several cancers” and should not be denied to PAD patients who are otherwise appropriate candidates. Although flares are common, more than half of PAD patients in this series did not flare and flares were mild to moderate in most of those who did.
“The response to checkpoint inhibitors in PAD patients is good,” Ms. Tison advised. For those who do flare, “we need prospective studies to understand which strategies provide a good balance of benefit to risk” for cancer immunotherapy and for the options to manage immune-related adverse events.
The study was not industry funded. Ms. Tison reported no potential conflicts of interest.
SOURCE: Tison A et al. Ann Rheum Dis. 2018;77(Suppl 2):147. EULAR Congress 2018, Abstract OP0196.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: Cancer patients who take a checkpoint inhibitor and have a preexisting autoimmune disease were significantly more likely to have a disease flare but also a better cancer outcome than were those without preexisting disease.
Major finding: In those with a disease flare, progression-free and overall survival were significantly improved (P = .016 and P = .004, respectively).
Study details: Retrospective multicenter study.
Disclosures: The study was not industry funded. Ms. Tison reported no potential conflicts of interest.
Source: Tison A et al. Ann Rheum Dis. 2018;77(Suppl 2):147. EULAR Congress 2018, Abstract OP0196.
Biologic efficacy differs in psoriatic arthritis by lymphocyte phenotype
AMSTERDAM – In patients with psoriatic arthritis (PsA), new evidence suggests selection of biologic disease-modifying antirheumatic drugs (bDMARDs) might be individualized by T-helper cell phenotype to improve disease control, according to the results of a study presented at the European Congress of Rheumatology.
“Our findings suggest a potential for precision medicine in patients with psoriatic arthritis,” reported Ippei Miyagawa, MD, of the University of Occupational and Environmental Health in Kitakyushu, Japan.
These phenotypes were employed to individualize therapy with the currently available targeted bDMARDs. Patients with a Th1-predominant phenotype received ustekinumab (Stelara), which blocks the p40 subunit of interleukin (IL)-12 and IL-23. Patients with a Th17-predominant phenotype received secukinumab (Cosentyx), which targets IL-17. Patients with the Th1/Th17-high phenotype received either secukinumab or a tumor necrosis factor inhibitor. Patients with the Th1/Th17-low phenotype received a TNF inhibitor.
The 26 patients whose bDMARD therapy was individualized were compared with 38 PsA patients who received bDMARDs selected according to EULAR recommendations. The groups were similar for baseline characteristics.
In both groups, there were significant decreases from baseline in essentially all clinical measures, including the Simplified Disease Activity Index, the Psoriasis Area and Severity Index, and the Patient Global Health Assessment. However, several disease markers suggested greater disease control in those receiving individualized therapy. For example, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) at 6 months was 0.76 in the Th17-predominant group versus 1.32 in those on an unselected bDMARD therapy (P = .008).
As a proportion of lymphocytes, Th1-predominant cells greater than 1.2% and Th17-predominant cells greater than 1.5% appeared to be sensitive cutoffs for predicting response to ustekinumab and secukinumab, respectively, according to data presented by Dr. Miyagawa. Although the results in this small series of patients are considered preliminary, Dr. Miyagawa said, “We think that this research is the first step toward the future use of precision medicine in PsA.”
Larger studies are needed to verify that lymphocyte phenotyping is an effective and reproducible strategy for individualizing selection of bDMARDs, but Dr. Miyagawa acknowledged other practical barriers to routine clinical application of this strategy. In particular, he called flow cytometry, which was employed in this study to phenotype lymphocyte expression, “complicated” for routine clinical use. However, this study strongly suggests that lymphocyte expression is a predictor of response to the different bDMARDs now available for treatment of PsA.
“The bDMARDs effective in PsA have different targets and may not offer the same degree of efficacy in all patients. Our study suggests an approach to optimal drug selection,” he said.
The study was not industry funded. Dr. Miyagawa reported no relevant financial disclosures.
SOURCE: Miyagawa I et al. Ann Rheum Dis. 2018;77(Suppl 2):206-7. EULAR Congress 2018, Abstract OP0321.
AMSTERDAM – In patients with psoriatic arthritis (PsA), new evidence suggests selection of biologic disease-modifying antirheumatic drugs (bDMARDs) might be individualized by T-helper cell phenotype to improve disease control, according to the results of a study presented at the European Congress of Rheumatology.
“Our findings suggest a potential for precision medicine in patients with psoriatic arthritis,” reported Ippei Miyagawa, MD, of the University of Occupational and Environmental Health in Kitakyushu, Japan.
These phenotypes were employed to individualize therapy with the currently available targeted bDMARDs. Patients with a Th1-predominant phenotype received ustekinumab (Stelara), which blocks the p40 subunit of interleukin (IL)-12 and IL-23. Patients with a Th17-predominant phenotype received secukinumab (Cosentyx), which targets IL-17. Patients with the Th1/Th17-high phenotype received either secukinumab or a tumor necrosis factor inhibitor. Patients with the Th1/Th17-low phenotype received a TNF inhibitor.
The 26 patients whose bDMARD therapy was individualized were compared with 38 PsA patients who received bDMARDs selected according to EULAR recommendations. The groups were similar for baseline characteristics.
In both groups, there were significant decreases from baseline in essentially all clinical measures, including the Simplified Disease Activity Index, the Psoriasis Area and Severity Index, and the Patient Global Health Assessment. However, several disease markers suggested greater disease control in those receiving individualized therapy. For example, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) at 6 months was 0.76 in the Th17-predominant group versus 1.32 in those on an unselected bDMARD therapy (P = .008).
As a proportion of lymphocytes, Th1-predominant cells greater than 1.2% and Th17-predominant cells greater than 1.5% appeared to be sensitive cutoffs for predicting response to ustekinumab and secukinumab, respectively, according to data presented by Dr. Miyagawa. Although the results in this small series of patients are considered preliminary, Dr. Miyagawa said, “We think that this research is the first step toward the future use of precision medicine in PsA.”
Larger studies are needed to verify that lymphocyte phenotyping is an effective and reproducible strategy for individualizing selection of bDMARDs, but Dr. Miyagawa acknowledged other practical barriers to routine clinical application of this strategy. In particular, he called flow cytometry, which was employed in this study to phenotype lymphocyte expression, “complicated” for routine clinical use. However, this study strongly suggests that lymphocyte expression is a predictor of response to the different bDMARDs now available for treatment of PsA.
“The bDMARDs effective in PsA have different targets and may not offer the same degree of efficacy in all patients. Our study suggests an approach to optimal drug selection,” he said.
The study was not industry funded. Dr. Miyagawa reported no relevant financial disclosures.
SOURCE: Miyagawa I et al. Ann Rheum Dis. 2018;77(Suppl 2):206-7. EULAR Congress 2018, Abstract OP0321.
AMSTERDAM – In patients with psoriatic arthritis (PsA), new evidence suggests selection of biologic disease-modifying antirheumatic drugs (bDMARDs) might be individualized by T-helper cell phenotype to improve disease control, according to the results of a study presented at the European Congress of Rheumatology.
“Our findings suggest a potential for precision medicine in patients with psoriatic arthritis,” reported Ippei Miyagawa, MD, of the University of Occupational and Environmental Health in Kitakyushu, Japan.
These phenotypes were employed to individualize therapy with the currently available targeted bDMARDs. Patients with a Th1-predominant phenotype received ustekinumab (Stelara), which blocks the p40 subunit of interleukin (IL)-12 and IL-23. Patients with a Th17-predominant phenotype received secukinumab (Cosentyx), which targets IL-17. Patients with the Th1/Th17-high phenotype received either secukinumab or a tumor necrosis factor inhibitor. Patients with the Th1/Th17-low phenotype received a TNF inhibitor.
The 26 patients whose bDMARD therapy was individualized were compared with 38 PsA patients who received bDMARDs selected according to EULAR recommendations. The groups were similar for baseline characteristics.
In both groups, there were significant decreases from baseline in essentially all clinical measures, including the Simplified Disease Activity Index, the Psoriasis Area and Severity Index, and the Patient Global Health Assessment. However, several disease markers suggested greater disease control in those receiving individualized therapy. For example, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) at 6 months was 0.76 in the Th17-predominant group versus 1.32 in those on an unselected bDMARD therapy (P = .008).
As a proportion of lymphocytes, Th1-predominant cells greater than 1.2% and Th17-predominant cells greater than 1.5% appeared to be sensitive cutoffs for predicting response to ustekinumab and secukinumab, respectively, according to data presented by Dr. Miyagawa. Although the results in this small series of patients are considered preliminary, Dr. Miyagawa said, “We think that this research is the first step toward the future use of precision medicine in PsA.”
Larger studies are needed to verify that lymphocyte phenotyping is an effective and reproducible strategy for individualizing selection of bDMARDs, but Dr. Miyagawa acknowledged other practical barriers to routine clinical application of this strategy. In particular, he called flow cytometry, which was employed in this study to phenotype lymphocyte expression, “complicated” for routine clinical use. However, this study strongly suggests that lymphocyte expression is a predictor of response to the different bDMARDs now available for treatment of PsA.
“The bDMARDs effective in PsA have different targets and may not offer the same degree of efficacy in all patients. Our study suggests an approach to optimal drug selection,” he said.
The study was not industry funded. Dr. Miyagawa reported no relevant financial disclosures.
SOURCE: Miyagawa I et al. Ann Rheum Dis. 2018;77(Suppl 2):206-7. EULAR Congress 2018, Abstract OP0321.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: Lymphocyte profile phenotypes appear to permit individualized biologic therapy in patients with PsA.
Major finding: Therapy individualized for Th17-predominant PsA produced a DAS28 score 0.56 points lower than did nonselected therapy (P = .008).
Study details: A prospective, nonrandomized study of 64 PsA patients with either individualized bDMARD therapy or bDMARDs selected according to EULAR recommendations.
Disclosures: The study was not industry funded. Dr. Miyagawa reported no relevant financial disclosures.
Source: Miyagawa I et al. Ann Rheum Dis. 2018;77(Suppl 2):206-7. EULAR Congress 2018, Abstract OP0321.
Risankizumab impresses in phase 2 psoriatic arthritis trial
AMSTERDAM – Phase 2 data with the IL-23 inhibitor risankizumab at week 24 were even more impressive than the week 16 data, showing that without any further dosing after week 16, all doses provided protection against radiographic progression relative to placebo at 24 weeks, according to data presented at the European Congress of Rheumatology.
In a video interview, first author Philip J. Mease, MD, a rheumatologist at Swedish Medical Center in Seattle, explained that it is not only the high rates of response to risankizumab but also the prolonged response that are attracting attention.
Risankizumab is among several monoclonal antibodies developed to target the p19 subunit of the proinflammatory cytokine IL-23. These drugs have already shown a high degree of efficacy for psoriasis, according to Dr. Mease. However, the new data with risankizumab confirm prolonged responses against a broad range of additional clinical targets specific to psoriatic arthritis, including bone destruction and enthesitis.
A prolonged response in patients treated with a single, relatively low dose of risankizumab is one of the intriguing findings. While three of the four active treatments arms received multiple infusions of 150 mg, the single-dose arm received only 75 mg of risankizumab once at baseline. At 16 weeks and 24 weeks, all arms, including the single-dose arm, met the primary endpoint of superiority to placebo for ACR20. At week 24, the single infusion of 75 mg was also providing significant benefit for several secondary endpoints, including radiographic progression.
However, the higher, more frequent doses did show greater efficacy overall. For example, patients in the arm with the most frequent dosing of risankizumab (every 4 weeks) and no dosing after week 16 continued to show significant improvement in enthesitis. A less frequent schedule of 150 mg risankizumab and the arm receiving a single dose of 75 mg risankizumab were not associated with a significant advantage over placebo for this endpoint.
Still, the prolonged responses at week 24 suggest that it may be possible to administer risankizumab at intervals that are less frequent than many other biologics.
So far, there “is nothing remarkable about safety,” Dr. Mease explained. A higher rate of infection relative to placebo was a treatment-emergent side effect in this study, but Dr. Mease said the drug is well tolerated.
Risankizumab is poised for evaluation in a phase 3 trial for psoriatic arthritis, and Dr. Mease was optimistic about its potential role, predicting that this, as well as other anti-IL23 p19 monoclonal antibodies, is likely to be an “important addition to our armamentarium.”
AbbVie and Boehringer Ingelheim funded the risankizumab study. Dr. Mease has received grant/research support from AbbVie and many other pharmaceutical companies. He also is a consultant to them and is on their speakers bureaus.
SOURCE: Mease P et al. Ann Rheum Dis. 2018;77(Suppl 2):200-1. Abstract OP0307
AMSTERDAM – Phase 2 data with the IL-23 inhibitor risankizumab at week 24 were even more impressive than the week 16 data, showing that without any further dosing after week 16, all doses provided protection against radiographic progression relative to placebo at 24 weeks, according to data presented at the European Congress of Rheumatology.
In a video interview, first author Philip J. Mease, MD, a rheumatologist at Swedish Medical Center in Seattle, explained that it is not only the high rates of response to risankizumab but also the prolonged response that are attracting attention.
Risankizumab is among several monoclonal antibodies developed to target the p19 subunit of the proinflammatory cytokine IL-23. These drugs have already shown a high degree of efficacy for psoriasis, according to Dr. Mease. However, the new data with risankizumab confirm prolonged responses against a broad range of additional clinical targets specific to psoriatic arthritis, including bone destruction and enthesitis.
A prolonged response in patients treated with a single, relatively low dose of risankizumab is one of the intriguing findings. While three of the four active treatments arms received multiple infusions of 150 mg, the single-dose arm received only 75 mg of risankizumab once at baseline. At 16 weeks and 24 weeks, all arms, including the single-dose arm, met the primary endpoint of superiority to placebo for ACR20. At week 24, the single infusion of 75 mg was also providing significant benefit for several secondary endpoints, including radiographic progression.
However, the higher, more frequent doses did show greater efficacy overall. For example, patients in the arm with the most frequent dosing of risankizumab (every 4 weeks) and no dosing after week 16 continued to show significant improvement in enthesitis. A less frequent schedule of 150 mg risankizumab and the arm receiving a single dose of 75 mg risankizumab were not associated with a significant advantage over placebo for this endpoint.
Still, the prolonged responses at week 24 suggest that it may be possible to administer risankizumab at intervals that are less frequent than many other biologics.
So far, there “is nothing remarkable about safety,” Dr. Mease explained. A higher rate of infection relative to placebo was a treatment-emergent side effect in this study, but Dr. Mease said the drug is well tolerated.
Risankizumab is poised for evaluation in a phase 3 trial for psoriatic arthritis, and Dr. Mease was optimistic about its potential role, predicting that this, as well as other anti-IL23 p19 monoclonal antibodies, is likely to be an “important addition to our armamentarium.”
AbbVie and Boehringer Ingelheim funded the risankizumab study. Dr. Mease has received grant/research support from AbbVie and many other pharmaceutical companies. He also is a consultant to them and is on their speakers bureaus.
SOURCE: Mease P et al. Ann Rheum Dis. 2018;77(Suppl 2):200-1. Abstract OP0307
AMSTERDAM – Phase 2 data with the IL-23 inhibitor risankizumab at week 24 were even more impressive than the week 16 data, showing that without any further dosing after week 16, all doses provided protection against radiographic progression relative to placebo at 24 weeks, according to data presented at the European Congress of Rheumatology.
In a video interview, first author Philip J. Mease, MD, a rheumatologist at Swedish Medical Center in Seattle, explained that it is not only the high rates of response to risankizumab but also the prolonged response that are attracting attention.
Risankizumab is among several monoclonal antibodies developed to target the p19 subunit of the proinflammatory cytokine IL-23. These drugs have already shown a high degree of efficacy for psoriasis, according to Dr. Mease. However, the new data with risankizumab confirm prolonged responses against a broad range of additional clinical targets specific to psoriatic arthritis, including bone destruction and enthesitis.
A prolonged response in patients treated with a single, relatively low dose of risankizumab is one of the intriguing findings. While three of the four active treatments arms received multiple infusions of 150 mg, the single-dose arm received only 75 mg of risankizumab once at baseline. At 16 weeks and 24 weeks, all arms, including the single-dose arm, met the primary endpoint of superiority to placebo for ACR20. At week 24, the single infusion of 75 mg was also providing significant benefit for several secondary endpoints, including radiographic progression.
However, the higher, more frequent doses did show greater efficacy overall. For example, patients in the arm with the most frequent dosing of risankizumab (every 4 weeks) and no dosing after week 16 continued to show significant improvement in enthesitis. A less frequent schedule of 150 mg risankizumab and the arm receiving a single dose of 75 mg risankizumab were not associated with a significant advantage over placebo for this endpoint.
Still, the prolonged responses at week 24 suggest that it may be possible to administer risankizumab at intervals that are less frequent than many other biologics.
So far, there “is nothing remarkable about safety,” Dr. Mease explained. A higher rate of infection relative to placebo was a treatment-emergent side effect in this study, but Dr. Mease said the drug is well tolerated.
Risankizumab is poised for evaluation in a phase 3 trial for psoriatic arthritis, and Dr. Mease was optimistic about its potential role, predicting that this, as well as other anti-IL23 p19 monoclonal antibodies, is likely to be an “important addition to our armamentarium.”
AbbVie and Boehringer Ingelheim funded the risankizumab study. Dr. Mease has received grant/research support from AbbVie and many other pharmaceutical companies. He also is a consultant to them and is on their speakers bureaus.
SOURCE: Mease P et al. Ann Rheum Dis. 2018;77(Suppl 2):200-1. Abstract OP0307
REPORTING FROM the EULAR 2018 Congress
EULAR scientific program highlights spectrum of translational research
EULAR 2018’s scientific program in Amsterdam is packed with lectures, clinical and basic science symposia, workshops, and special interest sessions covering the full spectrum of rheumatic diseases, said Dr. Robert Landewé, chair of the Scientific Program Committee.
“More than 5,000 scientific abstracts were submitted, which is an absolute, all-time record,” Dr. Landewé said. Four experts scored each abstract, and only the top 7% were invited for oral presentation during abstract sessions or symposia, he explained in an interview.
Wednesday, June 13
A high point of the 2018 scientific program is Wednesday’s opening plenary session, which will feature abstracts that were handpicked by Dr. Landewé and Dr. Thomas Dörner, professor of rheumatology at Charite Universitätsmedizin, Berlin. “This session includes highly scored abstracts, including late-breakers, on current advances in therapeutics and disease classification,” said Dr. Dörner, who chaired this year’s Abstract Selection Committee.
The plenary abstract session will cover new findings on gout and cardiovascular disease from CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study), long-term mortality in patients with early RA from the COBRA (Combinatietherapie Bij Reumatoide Artritis) study, the use of zoledronic acid to treat knee osteoarthritis with bone lesions, and the relationship between bisphosphonate drug holidays and hip fracture risk. Researchers also will discuss baricitinib in systemic lupus erythematosus (SLE), the value of MRI when treating remitted RA to target, the validation of SLE classification criteria, and draft classification criteria for ANCA-associated vasculitides.
A notable clinical science session on Wednesday will cover cancer and inflammation, Dr. Landewé said. “This is a topic of increasing interest because cancer and inflammation share mutual pathways.”
Novel cancer therapies such as immune checkpoint inhibitors have improved outcomes across a range of tumor types, but also can induce rheumatic disease, he added. Accordingly, presenters will discuss inflammation as “friend” versus “foe” in cancer treatment, the role of tumor necrosis factor in cancer, and risk of malignancy among patients with RA.
Also on Wednesday, a session will tackle the relationship between psychological distress and pain in immune-mediated disease. “Pain is the major symptom of rheumatic diseases, and the role of the psyche remains poorly understood,” Dr. Landewé said. “But we know one thing for sure: There is an association, and speakers from outside the field of rheumatology will help explain.”
Attendees at this bench-to-bedside session will learn how distress appears to exacerbate arthritis pain and how managing psychological stress can help optimize outcomes in arthritis pain. Experts also will describe research on integrated brain pathways in pain and distress, as well as risk factors for cognitive impairment in RA.
Thursday, June 14
Topics in this session will include the use of estrogens and other hormonal therapies in patients with rheumatic disease, registry studies of rheumatologic conditions during pregnancy, and how clinicians can best discuss sexual concerns with their rheumatology patients.
Another clinical science session scheduled for Thursday afternoon will delve into structural damage progression in patients with axial spondyloarthritis, Dr. Landewé said. “Can we inhibit this structural progression? Can we show it? Does it make sense? And which drug company will win the battle to have the precedent?”
He hopes that Dr. Désirée van der Heijde of the Netherlands and Dr. Xenofon Baraliakos of Germany will help answer these questions when they discuss the latest evidence on identifying and treating clinically relevant structural progression. Also in this session, researchers will describe the combined effects of tumor necrosis factor inhibitors and NSAIDs on radiographic progression in ankylosing spondylitis, and MRI evidence supporting treating early axial spondyloarthritis to target with the goal of achieving sustained remission of inflammation.
Also on Thursday afternoon, a case-based session will take a deep dive into giant cell arteritis (GCA), Dr. Landewé noted. Attendees will learn about diagnosing and managing vision loss and stroke and the latest on corticosteroid therapy in GCA. The session also will cover biologics. “Giant cell arteritis has entered the field of biologicals!” said Dr. Landewé. “This has major implications for this disease and the clinical choices to be made.”
The past 5 decades have seen marked progress in the diagnosis and treatment of SLE, with corresponding improvements in survival and quality of life. “Still, lupus is awfully difficult,” Dr. Landewé said. “Therefore, we have planned a classical bench-to-bedside symposium to provide an all-inclusive look at current thinking and future developments.”
Talks during this Thursday afternoon session will cover the latest findings on the pathogenesis of SLE, the clinical significance of autoantibodies, distinguishing early SLE from mimics, and the role of blood-brain barrier permeability and neuropsychiatric manifestations of SLE and progressive systemic sclerosis.
Friday, June 15
For the first time, the scientific program also will include a clinical science session held jointly with the European Society of Musculoskeletal Radiology (ESSR). Dr. Joachim Sieper of Germany and ESSR President Dr. Monique Reijnierse of the Netherlands will cochair the Friday afternoon session on the role of MRI in rheumatology. Attendees from both organizations will learn when to use MRI in early and established RA and spondyloarthritis, and how to interpret the results, with abundant time built in for questions and answers. Dr. Landewé called the joint session “a test case” for exciting web-based interactions between EULAR and ESSR.
Another clinical science session on Friday afternoon will dive into the diagnosis of spondyloarthritis, which Dr. Landewé called “a matter of recognizing patterns, not ticking boxes on a list of criteria. This symposium leads you through the art of pattern recognition.”
Later on Friday afternoon, a session will explore advances in biologic therapy of small-vessel vasculitis, he added. “Biologic disease-modifying antirheumatic drugs [bDMARDs] are becoming more and more important in this area of expanding interest.” Experts will address complement inhibition in ANCA-associated vasculitis (AAV), the use of induction and maintenance rituximab in AAV, the evolving role of mepolizumab in eosinophilic granulomatosis with polyangiitis, survival in AAV, and the use of rituximab for treating children with granulomatosis with polyangiitis and microscopic polyangiitis.
Saturday, June 16
On Saturday, a bench-to-bedside session will cover gout and kidney function. “This is an area with important new insights,” Dr. Dörner said. Presenters will discuss the genetics of hyperuricemia, renal urate transporters, and the pros and cons of using xanthine oxidase inhibitors to treat chronic kidney disease. Researchers will also cover studies of impaired neutrophil chemotaxis in patients with chronic kidney disease and hyperuricemia, and the relationship between renal medullar hyperechogenicity and gout severity.
Also on Saturday, a clinical science session titled, “Rheumatoid arthritis: Is it all in your head?” will explore emerging data on the relationship between inflammation and depression. Patients with RA often face both clinical depression and social isolation, and these complex psychosocial conditions can worsen one another. “In addition to proper drug choice, treating RA effectively depends on how concomitant problems, such as nonspecific pain, depression, and social isolation, are coped with in a broad context,” Dr. Landewé said. “When it comes to optimal management, rheumatologists need to communicate and prescribe, not just prescribe.”
Christian Apfelbacher, PhD, of Germany will discuss prevention and treatment strategies and Dr. Jonathan Cavanagh of the United Kingdom will cover neuroimaging in RA. Researchers also will discuss new findings on pain, depression, and anxiety in patients recently diagnosed with RA.
Also on Saturday, a special session will cover EULAR’s initiatives to improve clinical approaches (ESSCA), Dr. Dörner noted. This effort has produced new or updated recommendations on topics such as vaccination, Sjögren’s syndrome, glucocorticoid therapy, and management of hand osteoarthritis, he said. “These recommendations follow a number of others and are expected to impact clinical science as well as clinical practice.”
EULAR 2018’s scientific program in Amsterdam is packed with lectures, clinical and basic science symposia, workshops, and special interest sessions covering the full spectrum of rheumatic diseases, said Dr. Robert Landewé, chair of the Scientific Program Committee.
“More than 5,000 scientific abstracts were submitted, which is an absolute, all-time record,” Dr. Landewé said. Four experts scored each abstract, and only the top 7% were invited for oral presentation during abstract sessions or symposia, he explained in an interview.
Wednesday, June 13
A high point of the 2018 scientific program is Wednesday’s opening plenary session, which will feature abstracts that were handpicked by Dr. Landewé and Dr. Thomas Dörner, professor of rheumatology at Charite Universitätsmedizin, Berlin. “This session includes highly scored abstracts, including late-breakers, on current advances in therapeutics and disease classification,” said Dr. Dörner, who chaired this year’s Abstract Selection Committee.
The plenary abstract session will cover new findings on gout and cardiovascular disease from CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study), long-term mortality in patients with early RA from the COBRA (Combinatietherapie Bij Reumatoide Artritis) study, the use of zoledronic acid to treat knee osteoarthritis with bone lesions, and the relationship between bisphosphonate drug holidays and hip fracture risk. Researchers also will discuss baricitinib in systemic lupus erythematosus (SLE), the value of MRI when treating remitted RA to target, the validation of SLE classification criteria, and draft classification criteria for ANCA-associated vasculitides.
A notable clinical science session on Wednesday will cover cancer and inflammation, Dr. Landewé said. “This is a topic of increasing interest because cancer and inflammation share mutual pathways.”
Novel cancer therapies such as immune checkpoint inhibitors have improved outcomes across a range of tumor types, but also can induce rheumatic disease, he added. Accordingly, presenters will discuss inflammation as “friend” versus “foe” in cancer treatment, the role of tumor necrosis factor in cancer, and risk of malignancy among patients with RA.
Also on Wednesday, a session will tackle the relationship between psychological distress and pain in immune-mediated disease. “Pain is the major symptom of rheumatic diseases, and the role of the psyche remains poorly understood,” Dr. Landewé said. “But we know one thing for sure: There is an association, and speakers from outside the field of rheumatology will help explain.”
Attendees at this bench-to-bedside session will learn how distress appears to exacerbate arthritis pain and how managing psychological stress can help optimize outcomes in arthritis pain. Experts also will describe research on integrated brain pathways in pain and distress, as well as risk factors for cognitive impairment in RA.
Thursday, June 14
Topics in this session will include the use of estrogens and other hormonal therapies in patients with rheumatic disease, registry studies of rheumatologic conditions during pregnancy, and how clinicians can best discuss sexual concerns with their rheumatology patients.
Another clinical science session scheduled for Thursday afternoon will delve into structural damage progression in patients with axial spondyloarthritis, Dr. Landewé said. “Can we inhibit this structural progression? Can we show it? Does it make sense? And which drug company will win the battle to have the precedent?”
He hopes that Dr. Désirée van der Heijde of the Netherlands and Dr. Xenofon Baraliakos of Germany will help answer these questions when they discuss the latest evidence on identifying and treating clinically relevant structural progression. Also in this session, researchers will describe the combined effects of tumor necrosis factor inhibitors and NSAIDs on radiographic progression in ankylosing spondylitis, and MRI evidence supporting treating early axial spondyloarthritis to target with the goal of achieving sustained remission of inflammation.
Also on Thursday afternoon, a case-based session will take a deep dive into giant cell arteritis (GCA), Dr. Landewé noted. Attendees will learn about diagnosing and managing vision loss and stroke and the latest on corticosteroid therapy in GCA. The session also will cover biologics. “Giant cell arteritis has entered the field of biologicals!” said Dr. Landewé. “This has major implications for this disease and the clinical choices to be made.”
The past 5 decades have seen marked progress in the diagnosis and treatment of SLE, with corresponding improvements in survival and quality of life. “Still, lupus is awfully difficult,” Dr. Landewé said. “Therefore, we have planned a classical bench-to-bedside symposium to provide an all-inclusive look at current thinking and future developments.”
Talks during this Thursday afternoon session will cover the latest findings on the pathogenesis of SLE, the clinical significance of autoantibodies, distinguishing early SLE from mimics, and the role of blood-brain barrier permeability and neuropsychiatric manifestations of SLE and progressive systemic sclerosis.
Friday, June 15
For the first time, the scientific program also will include a clinical science session held jointly with the European Society of Musculoskeletal Radiology (ESSR). Dr. Joachim Sieper of Germany and ESSR President Dr. Monique Reijnierse of the Netherlands will cochair the Friday afternoon session on the role of MRI in rheumatology. Attendees from both organizations will learn when to use MRI in early and established RA and spondyloarthritis, and how to interpret the results, with abundant time built in for questions and answers. Dr. Landewé called the joint session “a test case” for exciting web-based interactions between EULAR and ESSR.
Another clinical science session on Friday afternoon will dive into the diagnosis of spondyloarthritis, which Dr. Landewé called “a matter of recognizing patterns, not ticking boxes on a list of criteria. This symposium leads you through the art of pattern recognition.”
Later on Friday afternoon, a session will explore advances in biologic therapy of small-vessel vasculitis, he added. “Biologic disease-modifying antirheumatic drugs [bDMARDs] are becoming more and more important in this area of expanding interest.” Experts will address complement inhibition in ANCA-associated vasculitis (AAV), the use of induction and maintenance rituximab in AAV, the evolving role of mepolizumab in eosinophilic granulomatosis with polyangiitis, survival in AAV, and the use of rituximab for treating children with granulomatosis with polyangiitis and microscopic polyangiitis.
Saturday, June 16
On Saturday, a bench-to-bedside session will cover gout and kidney function. “This is an area with important new insights,” Dr. Dörner said. Presenters will discuss the genetics of hyperuricemia, renal urate transporters, and the pros and cons of using xanthine oxidase inhibitors to treat chronic kidney disease. Researchers will also cover studies of impaired neutrophil chemotaxis in patients with chronic kidney disease and hyperuricemia, and the relationship between renal medullar hyperechogenicity and gout severity.
Also on Saturday, a clinical science session titled, “Rheumatoid arthritis: Is it all in your head?” will explore emerging data on the relationship between inflammation and depression. Patients with RA often face both clinical depression and social isolation, and these complex psychosocial conditions can worsen one another. “In addition to proper drug choice, treating RA effectively depends on how concomitant problems, such as nonspecific pain, depression, and social isolation, are coped with in a broad context,” Dr. Landewé said. “When it comes to optimal management, rheumatologists need to communicate and prescribe, not just prescribe.”
Christian Apfelbacher, PhD, of Germany will discuss prevention and treatment strategies and Dr. Jonathan Cavanagh of the United Kingdom will cover neuroimaging in RA. Researchers also will discuss new findings on pain, depression, and anxiety in patients recently diagnosed with RA.
Also on Saturday, a special session will cover EULAR’s initiatives to improve clinical approaches (ESSCA), Dr. Dörner noted. This effort has produced new or updated recommendations on topics such as vaccination, Sjögren’s syndrome, glucocorticoid therapy, and management of hand osteoarthritis, he said. “These recommendations follow a number of others and are expected to impact clinical science as well as clinical practice.”
EULAR 2018’s scientific program in Amsterdam is packed with lectures, clinical and basic science symposia, workshops, and special interest sessions covering the full spectrum of rheumatic diseases, said Dr. Robert Landewé, chair of the Scientific Program Committee.
“More than 5,000 scientific abstracts were submitted, which is an absolute, all-time record,” Dr. Landewé said. Four experts scored each abstract, and only the top 7% were invited for oral presentation during abstract sessions or symposia, he explained in an interview.
Wednesday, June 13
A high point of the 2018 scientific program is Wednesday’s opening plenary session, which will feature abstracts that were handpicked by Dr. Landewé and Dr. Thomas Dörner, professor of rheumatology at Charite Universitätsmedizin, Berlin. “This session includes highly scored abstracts, including late-breakers, on current advances in therapeutics and disease classification,” said Dr. Dörner, who chaired this year’s Abstract Selection Committee.
The plenary abstract session will cover new findings on gout and cardiovascular disease from CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcome Study), long-term mortality in patients with early RA from the COBRA (Combinatietherapie Bij Reumatoide Artritis) study, the use of zoledronic acid to treat knee osteoarthritis with bone lesions, and the relationship between bisphosphonate drug holidays and hip fracture risk. Researchers also will discuss baricitinib in systemic lupus erythematosus (SLE), the value of MRI when treating remitted RA to target, the validation of SLE classification criteria, and draft classification criteria for ANCA-associated vasculitides.
A notable clinical science session on Wednesday will cover cancer and inflammation, Dr. Landewé said. “This is a topic of increasing interest because cancer and inflammation share mutual pathways.”
Novel cancer therapies such as immune checkpoint inhibitors have improved outcomes across a range of tumor types, but also can induce rheumatic disease, he added. Accordingly, presenters will discuss inflammation as “friend” versus “foe” in cancer treatment, the role of tumor necrosis factor in cancer, and risk of malignancy among patients with RA.
Also on Wednesday, a session will tackle the relationship between psychological distress and pain in immune-mediated disease. “Pain is the major symptom of rheumatic diseases, and the role of the psyche remains poorly understood,” Dr. Landewé said. “But we know one thing for sure: There is an association, and speakers from outside the field of rheumatology will help explain.”
Attendees at this bench-to-bedside session will learn how distress appears to exacerbate arthritis pain and how managing psychological stress can help optimize outcomes in arthritis pain. Experts also will describe research on integrated brain pathways in pain and distress, as well as risk factors for cognitive impairment in RA.
Thursday, June 14
Topics in this session will include the use of estrogens and other hormonal therapies in patients with rheumatic disease, registry studies of rheumatologic conditions during pregnancy, and how clinicians can best discuss sexual concerns with their rheumatology patients.
Another clinical science session scheduled for Thursday afternoon will delve into structural damage progression in patients with axial spondyloarthritis, Dr. Landewé said. “Can we inhibit this structural progression? Can we show it? Does it make sense? And which drug company will win the battle to have the precedent?”
He hopes that Dr. Désirée van der Heijde of the Netherlands and Dr. Xenofon Baraliakos of Germany will help answer these questions when they discuss the latest evidence on identifying and treating clinically relevant structural progression. Also in this session, researchers will describe the combined effects of tumor necrosis factor inhibitors and NSAIDs on radiographic progression in ankylosing spondylitis, and MRI evidence supporting treating early axial spondyloarthritis to target with the goal of achieving sustained remission of inflammation.
Also on Thursday afternoon, a case-based session will take a deep dive into giant cell arteritis (GCA), Dr. Landewé noted. Attendees will learn about diagnosing and managing vision loss and stroke and the latest on corticosteroid therapy in GCA. The session also will cover biologics. “Giant cell arteritis has entered the field of biologicals!” said Dr. Landewé. “This has major implications for this disease and the clinical choices to be made.”
The past 5 decades have seen marked progress in the diagnosis and treatment of SLE, with corresponding improvements in survival and quality of life. “Still, lupus is awfully difficult,” Dr. Landewé said. “Therefore, we have planned a classical bench-to-bedside symposium to provide an all-inclusive look at current thinking and future developments.”
Talks during this Thursday afternoon session will cover the latest findings on the pathogenesis of SLE, the clinical significance of autoantibodies, distinguishing early SLE from mimics, and the role of blood-brain barrier permeability and neuropsychiatric manifestations of SLE and progressive systemic sclerosis.
Friday, June 15
For the first time, the scientific program also will include a clinical science session held jointly with the European Society of Musculoskeletal Radiology (ESSR). Dr. Joachim Sieper of Germany and ESSR President Dr. Monique Reijnierse of the Netherlands will cochair the Friday afternoon session on the role of MRI in rheumatology. Attendees from both organizations will learn when to use MRI in early and established RA and spondyloarthritis, and how to interpret the results, with abundant time built in for questions and answers. Dr. Landewé called the joint session “a test case” for exciting web-based interactions between EULAR and ESSR.
Another clinical science session on Friday afternoon will dive into the diagnosis of spondyloarthritis, which Dr. Landewé called “a matter of recognizing patterns, not ticking boxes on a list of criteria. This symposium leads you through the art of pattern recognition.”
Later on Friday afternoon, a session will explore advances in biologic therapy of small-vessel vasculitis, he added. “Biologic disease-modifying antirheumatic drugs [bDMARDs] are becoming more and more important in this area of expanding interest.” Experts will address complement inhibition in ANCA-associated vasculitis (AAV), the use of induction and maintenance rituximab in AAV, the evolving role of mepolizumab in eosinophilic granulomatosis with polyangiitis, survival in AAV, and the use of rituximab for treating children with granulomatosis with polyangiitis and microscopic polyangiitis.
Saturday, June 16
On Saturday, a bench-to-bedside session will cover gout and kidney function. “This is an area with important new insights,” Dr. Dörner said. Presenters will discuss the genetics of hyperuricemia, renal urate transporters, and the pros and cons of using xanthine oxidase inhibitors to treat chronic kidney disease. Researchers will also cover studies of impaired neutrophil chemotaxis in patients with chronic kidney disease and hyperuricemia, and the relationship between renal medullar hyperechogenicity and gout severity.
Also on Saturday, a clinical science session titled, “Rheumatoid arthritis: Is it all in your head?” will explore emerging data on the relationship between inflammation and depression. Patients with RA often face both clinical depression and social isolation, and these complex psychosocial conditions can worsen one another. “In addition to proper drug choice, treating RA effectively depends on how concomitant problems, such as nonspecific pain, depression, and social isolation, are coped with in a broad context,” Dr. Landewé said. “When it comes to optimal management, rheumatologists need to communicate and prescribe, not just prescribe.”
Christian Apfelbacher, PhD, of Germany will discuss prevention and treatment strategies and Dr. Jonathan Cavanagh of the United Kingdom will cover neuroimaging in RA. Researchers also will discuss new findings on pain, depression, and anxiety in patients recently diagnosed with RA.
Also on Saturday, a special session will cover EULAR’s initiatives to improve clinical approaches (ESSCA), Dr. Dörner noted. This effort has produced new or updated recommendations on topics such as vaccination, Sjögren’s syndrome, glucocorticoid therapy, and management of hand osteoarthritis, he said. “These recommendations follow a number of others and are expected to impact clinical science as well as clinical practice.”
Psoriasis therapy with biologics not linked to increased cancer risk
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Biologic treatments were not associated with an increased risk of cancer among patients with psoriasis in the medium term, in a study that analyzed data from patient registries.
“Cumulative length of exposure to biologics was not associated with the risk of developing cancers, even after controlling for the effect of age, gender, location,” as well as for previous exposure to methotrexate, cyclosporine, and phototherapy; duration of psoriasis; and comorbidities, reported Ignacio García-Doval, MD, of the Fundación Academia Española de Dermatología y Venereología, Madrid, and his associates.
The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02 (95% confidence interval, 0.92-1.13), demonstrating no significantly increased risk of cancer per cumulative year of biologic exposure for psoriasis therapy, Dr. García-Doval and his associates reported in the study, published in the British Journal of Dermatology. This was true even when broken down within the registries for comparison, and when analyzed by type of cancers, such as squamous cell carcinoma and basal cell carcinoma.
A limitation of the study was inadequate power to detect and compare risk between individual biologics, they said. Also, “as our data describe limited follow-up and latencies, it is still possible that a risk after longer periods of exposure and latencies exists.”
Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
SOURCE: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point:
Major finding: The pooled adjusted odds ratio of cancer per year of biologic exposure was 1.02.
Study details: Patient data were drawn from four national databases within Psonet, which included 579 cancer cases and 2,671 matched controls.
Disclosures: Most of the authors had numerous financial disclosures related to pharmaceutical companies. Psonet was supported with funds from the European Association of Venereology and Dermatology and the Italian Drug Agency. Funding for the individual registries includes support from pharmaceutical companies.
Source: García-Doval I et al. Br J Dermatol. 2018 May 3. doi: 10.1111/bjd.16715.
Effects of psoriatic arthritis not just physical
conducted by the Harris Poll on behalf of Pfizer.
Over 90% of respondents said that their psoriatic arthritis had negatively impacted their emotional and mental well-being and 75% reported negative effects on their relationships with friends and family, Pfizer reported. Among the 301 adults aged 18 years and older who responded to the survey, 58% had stopped participating in sports or recreational activities and 51% had stopped participating in social activities.
The effects on patients’ professional lives also were considerable: Almost 74% said that it had a negative effect on their career path, 41% had experienced decreased productivity, and 13% had quit or been let go from a job, Pfizer said.
Some of the survey results suggested a disconnect between patients and their physicians. Of the 89% of patients who were very or somewhat satisfied with their prescription medication, 90% said that they would like to make changes to their treatment regimen and 89% described their illness as moderate to severe, Pfizer reported.
The survey was conducted online from Nov. 2 to Dec. 1, 2017.
conducted by the Harris Poll on behalf of Pfizer.
Over 90% of respondents said that their psoriatic arthritis had negatively impacted their emotional and mental well-being and 75% reported negative effects on their relationships with friends and family, Pfizer reported. Among the 301 adults aged 18 years and older who responded to the survey, 58% had stopped participating in sports or recreational activities and 51% had stopped participating in social activities.
The effects on patients’ professional lives also were considerable: Almost 74% said that it had a negative effect on their career path, 41% had experienced decreased productivity, and 13% had quit or been let go from a job, Pfizer said.
Some of the survey results suggested a disconnect between patients and their physicians. Of the 89% of patients who were very or somewhat satisfied with their prescription medication, 90% said that they would like to make changes to their treatment regimen and 89% described their illness as moderate to severe, Pfizer reported.
The survey was conducted online from Nov. 2 to Dec. 1, 2017.
conducted by the Harris Poll on behalf of Pfizer.
Over 90% of respondents said that their psoriatic arthritis had negatively impacted their emotional and mental well-being and 75% reported negative effects on their relationships with friends and family, Pfizer reported. Among the 301 adults aged 18 years and older who responded to the survey, 58% had stopped participating in sports or recreational activities and 51% had stopped participating in social activities.
The effects on patients’ professional lives also were considerable: Almost 74% said that it had a negative effect on their career path, 41% had experienced decreased productivity, and 13% had quit or been let go from a job, Pfizer said.
Some of the survey results suggested a disconnect between patients and their physicians. Of the 89% of patients who were very or somewhat satisfied with their prescription medication, 90% said that they would like to make changes to their treatment regimen and 89% described their illness as moderate to severe, Pfizer reported.
The survey was conducted online from Nov. 2 to Dec. 1, 2017.
Ixekizumab improves psoriatic arthritis patient-reported outcomes
LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.
Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.
Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.
A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).
“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.
The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.
Dr. Marzo-Ortega noted that the study had only been powered to show a difference between the active treatment and placebo, and not between the two doses, and that, looking at the speed of response, a difference from placebo was already being seen by week 2 “and certainly by week 4,” indicating an early effect. Data from the trial at 52 weeks are being analyzed and should be available soon, she said.
Another efficacy measure used was the percentage of patients achieving minimum disease activity at week 24. “These are stringent criteria to achieve: Five of seven criteria need to be met,” Dr. Marzo-Ortega said. “This was achieved by almost 30% of patients on the 4-weekly dose,” and by 24% on the 2-weekly dose, but by just 3% of those given placebo.
“One of the remarkable things is that nearly a third [of patients] achieved PASI [Psoriasis Area Severity Index] 100 by week 24, which is complete resolution of skin psoriasis,” she said. This is one of the first times this type of skin response has been seen in a psoriasis trial, she noted.
However, there was little difference between the active treatment and placebo arms in terms of the percentage of patients seeing a response on enthesitis, and only the dose taken every 4 weeks had a significant benefit over placebo in terms of improving dactylitis.
It is not clear why these modest results were seen in the joints, perhaps there were too few patients. While this is surprising, Dr. Marzo-Ortega noted that she “wouldn’t put too much weight on” the lack of an enthesis response; these are “fantastic drugs for the skin,” she said. “There is no doubt about it.”
Other findings from the trial included a significant improvement in itch with both ixekizumab regimens versus placebo, as shown by a greater reduction in numerical rating scale scores from baseline to week 24 (–3.4 and –3.5 vs. –1.2; P less than .001).
Significant improvements with ixekizumab versus placebo in patients’ mental and physical health were also seen when data from the Short Form–36 and EQ-5D instruments were analyzed.
There was also evidence that treatment with ixekizumab significantly improved patients’ presenteeism, work productivity, and activity impairment at work when compared against placebo. There was no difference in absenteeism, as measured by changes in Work Productivity and Activity Impairment Questionnaire–Specific Health Problem scores from baseline to week 24.
SPIRIT-P2 is one of two pivotal trials conducted with ixekizumab in patients with psoriatic arthritis; the other is SPIRIT-P1, which was conducted in biologic-naive patients (Ann Rheum Dis. 2017;76[1]:79-87). Investigators recently reported 1-year data from it (J Rheumatol. 2018;45[3]:367-77.).
Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
SOURCE: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
REPORTING FROM RHEUMATOLOGY 2018
Key clinical point: Ixekizumab has multiple beneficial effects in patients with psoriatic arthritis previously treated with biologics.
Major finding: Mean HAQ-DI score changes (baseline to week 24) were –0.4 and –0.6 with ixekizumab (80 mg every 2 or 4 weeks) and –0.2 for placebo (P less than or equal to .001).
Study details: SPIRIT-P2: A randomized, double-blind, placebo-controlled phase 3 trial of ixekizumab in 363 biologic-experienced patients.
Disclosures: Eli Lilly, which markets ixekizumab as Taltz, sponsored the study. Dr. Marzo-Ortega disclosed receiving honoraria from AbbVie, Celgene, Eli Lilly, Novartis, and UCB, and honoraria and research funding from Janssen and Pfizer. Several other authors reported disclosures with many manufacturers of biologics for psoriatic arthritis, including Eli Lilly.
Source: Marzo-Ortega H et al. Rheumatology. 2018;57[Suppl. 3]:key075.185.
Psoriatic arthritis patients’ cardiovascular risks aren’t spurring increased management
CAMBRIDGE, MASS. – Patients with psoriatic arthritis (PsA) receive risk factor management and follow-up for atherosclerotic cardiovascular disease (ASCVD) that is similar to the population at large, according to research presented in a poster session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
The researchers found that patients with PsA in their single-center study did not receive more intensive management and follow-up despite having a higher risk score for ASCVD. This may be caused in part by the fact that there are no specific guidelines for ASCVD management in patients with PsA, according to study authors Linh Truong, MD, and Nicole Ridolfi, DO, internal medicine residents at the University of California, Irvine.
Even though this study and others have shown that patients with psoriatic arthritis have a higher risk for ASCVD, “currently, patients with PsA are being managed exactly the same way as everyone else,” Dr. Truong said.
In addition to assessing ASCVD morbidity in patients with PsA, Dr. Truong and Dr. Ridolfi also wanted to investigate how management of the known ASCVD risk in these patients in a primary care settings compared with national guidelines. Their research came in two parts. In the first part, they calculated 10-year ASCVD risk using a risk score estimator from the American Heart Association/American College of Cardiology. They then calculated an odds ratio for relevant atherosclerotic cardiovascular disease events, such as MI, heart failure, and cerebrovascular accidents. In the second part, they evaluated how the risk factors for ASCVD in patients with PsA were managed in the primary care setting.
The researchers compared data from a single center for 103 patients – 61 with PsA and 42 matching controls. Patients in both groups had an average age in the mid-60s, an average body mass index above 29 kg/m2, and were also mostly male (four patients with PsA were female) and mostly white.
Patients with PsA had an average ASCVD risk score of 21.2, compared with a score of 16.5 in the control arm (P less than .0001).
Of patients with psoriatic arthritis, 23 experienced an ASCVD event, compared with 10 patients in the control arm (OR, 1.93; 95% confidence interval, 0.80-4.66). Patients with PsA appeared to experience increased risk for MI (OR, 2.5), heart failure (OR, 7.09), and cerebrovascular accident (OR, 1.96). These increased risks had confidence intervals that approached statistical significance, but did not achieve it.
“We believe that because these data approach [statistical] significance, that further studies are needed,” Dr. Ridolfi said. “Our own validation studies are currently underway.”
In part two of the study, yearly ASCVD risk outcomes were averaged over 5 years and then evaluated based on the frequency of primary care visits, lab checks for HbA1c and lipid profile, and the use of cardioprotective ancillary referrals. The researchers also investigated statin and aspirin use in primary and secondary atherosclerotic cardiovascular disease per guidelines from the American College of Cardiology/American Heart Association and the United States Preventive Services Task Force.
Patients in both groups had similar primary care visits, HbA1c and lipid profiles, and use of cardioprotective supplements (such as fish oil and niacin). However, 36% of patients in the control arm received a nonpharmacologic ancillary referral, compared with just 11% of patients with PsA. Those referrals were in regard to weight loss and diabetes and dietary education, according to the research.
Dr. Truong and Dr. Ridolfi reported that, for primary prevention of ASCVD, PsA patients received treatment less often than did the controls with aspirin (0% vs. 26%, respectively) and statins (40% vs. 50%); there was also less use of statins for secondary prevention (73% vs. 85%).
“These data show that there is an educational opportunity in the primary care setting,” Dr. Truong said. “Or that there is an argument to be made that PsA should be managed by a rheumatology specialist.”
Dr. Truong and Dr. Ridolfi reported no disclosures.
CAMBRIDGE, MASS. – Patients with psoriatic arthritis (PsA) receive risk factor management and follow-up for atherosclerotic cardiovascular disease (ASCVD) that is similar to the population at large, according to research presented in a poster session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
The researchers found that patients with PsA in their single-center study did not receive more intensive management and follow-up despite having a higher risk score for ASCVD. This may be caused in part by the fact that there are no specific guidelines for ASCVD management in patients with PsA, according to study authors Linh Truong, MD, and Nicole Ridolfi, DO, internal medicine residents at the University of California, Irvine.
Even though this study and others have shown that patients with psoriatic arthritis have a higher risk for ASCVD, “currently, patients with PsA are being managed exactly the same way as everyone else,” Dr. Truong said.
In addition to assessing ASCVD morbidity in patients with PsA, Dr. Truong and Dr. Ridolfi also wanted to investigate how management of the known ASCVD risk in these patients in a primary care settings compared with national guidelines. Their research came in two parts. In the first part, they calculated 10-year ASCVD risk using a risk score estimator from the American Heart Association/American College of Cardiology. They then calculated an odds ratio for relevant atherosclerotic cardiovascular disease events, such as MI, heart failure, and cerebrovascular accidents. In the second part, they evaluated how the risk factors for ASCVD in patients with PsA were managed in the primary care setting.
The researchers compared data from a single center for 103 patients – 61 with PsA and 42 matching controls. Patients in both groups had an average age in the mid-60s, an average body mass index above 29 kg/m2, and were also mostly male (four patients with PsA were female) and mostly white.
Patients with PsA had an average ASCVD risk score of 21.2, compared with a score of 16.5 in the control arm (P less than .0001).
Of patients with psoriatic arthritis, 23 experienced an ASCVD event, compared with 10 patients in the control arm (OR, 1.93; 95% confidence interval, 0.80-4.66). Patients with PsA appeared to experience increased risk for MI (OR, 2.5), heart failure (OR, 7.09), and cerebrovascular accident (OR, 1.96). These increased risks had confidence intervals that approached statistical significance, but did not achieve it.
“We believe that because these data approach [statistical] significance, that further studies are needed,” Dr. Ridolfi said. “Our own validation studies are currently underway.”
In part two of the study, yearly ASCVD risk outcomes were averaged over 5 years and then evaluated based on the frequency of primary care visits, lab checks for HbA1c and lipid profile, and the use of cardioprotective ancillary referrals. The researchers also investigated statin and aspirin use in primary and secondary atherosclerotic cardiovascular disease per guidelines from the American College of Cardiology/American Heart Association and the United States Preventive Services Task Force.
Patients in both groups had similar primary care visits, HbA1c and lipid profiles, and use of cardioprotective supplements (such as fish oil and niacin). However, 36% of patients in the control arm received a nonpharmacologic ancillary referral, compared with just 11% of patients with PsA. Those referrals were in regard to weight loss and diabetes and dietary education, according to the research.
Dr. Truong and Dr. Ridolfi reported that, for primary prevention of ASCVD, PsA patients received treatment less often than did the controls with aspirin (0% vs. 26%, respectively) and statins (40% vs. 50%); there was also less use of statins for secondary prevention (73% vs. 85%).
“These data show that there is an educational opportunity in the primary care setting,” Dr. Truong said. “Or that there is an argument to be made that PsA should be managed by a rheumatology specialist.”
Dr. Truong and Dr. Ridolfi reported no disclosures.
CAMBRIDGE, MASS. – Patients with psoriatic arthritis (PsA) receive risk factor management and follow-up for atherosclerotic cardiovascular disease (ASCVD) that is similar to the population at large, according to research presented in a poster session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
The researchers found that patients with PsA in their single-center study did not receive more intensive management and follow-up despite having a higher risk score for ASCVD. This may be caused in part by the fact that there are no specific guidelines for ASCVD management in patients with PsA, according to study authors Linh Truong, MD, and Nicole Ridolfi, DO, internal medicine residents at the University of California, Irvine.
Even though this study and others have shown that patients with psoriatic arthritis have a higher risk for ASCVD, “currently, patients with PsA are being managed exactly the same way as everyone else,” Dr. Truong said.
In addition to assessing ASCVD morbidity in patients with PsA, Dr. Truong and Dr. Ridolfi also wanted to investigate how management of the known ASCVD risk in these patients in a primary care settings compared with national guidelines. Their research came in two parts. In the first part, they calculated 10-year ASCVD risk using a risk score estimator from the American Heart Association/American College of Cardiology. They then calculated an odds ratio for relevant atherosclerotic cardiovascular disease events, such as MI, heart failure, and cerebrovascular accidents. In the second part, they evaluated how the risk factors for ASCVD in patients with PsA were managed in the primary care setting.
The researchers compared data from a single center for 103 patients – 61 with PsA and 42 matching controls. Patients in both groups had an average age in the mid-60s, an average body mass index above 29 kg/m2, and were also mostly male (four patients with PsA were female) and mostly white.
Patients with PsA had an average ASCVD risk score of 21.2, compared with a score of 16.5 in the control arm (P less than .0001).
Of patients with psoriatic arthritis, 23 experienced an ASCVD event, compared with 10 patients in the control arm (OR, 1.93; 95% confidence interval, 0.80-4.66). Patients with PsA appeared to experience increased risk for MI (OR, 2.5), heart failure (OR, 7.09), and cerebrovascular accident (OR, 1.96). These increased risks had confidence intervals that approached statistical significance, but did not achieve it.
“We believe that because these data approach [statistical] significance, that further studies are needed,” Dr. Ridolfi said. “Our own validation studies are currently underway.”
In part two of the study, yearly ASCVD risk outcomes were averaged over 5 years and then evaluated based on the frequency of primary care visits, lab checks for HbA1c and lipid profile, and the use of cardioprotective ancillary referrals. The researchers also investigated statin and aspirin use in primary and secondary atherosclerotic cardiovascular disease per guidelines from the American College of Cardiology/American Heart Association and the United States Preventive Services Task Force.
Patients in both groups had similar primary care visits, HbA1c and lipid profiles, and use of cardioprotective supplements (such as fish oil and niacin). However, 36% of patients in the control arm received a nonpharmacologic ancillary referral, compared with just 11% of patients with PsA. Those referrals were in regard to weight loss and diabetes and dietary education, according to the research.
Dr. Truong and Dr. Ridolfi reported that, for primary prevention of ASCVD, PsA patients received treatment less often than did the controls with aspirin (0% vs. 26%, respectively) and statins (40% vs. 50%); there was also less use of statins for secondary prevention (73% vs. 85%).
“These data show that there is an educational opportunity in the primary care setting,” Dr. Truong said. “Or that there is an argument to be made that PsA should be managed by a rheumatology specialist.”
Dr. Truong and Dr. Ridolfi reported no disclosures.
REPORTING FROM SPARTAN 2018
Key clinical point: PsA patients have increased risk for ASCVD but are managed with the same intensity as the general population.
Major finding: Patients with PsA had an average ASCVD risk score of 21.2, compared with a score of 16.5 in the control arm.
Study details: A single-center study of 61 patients with PsA and 42 matching controls.
Disclosures: The presenters reported having no disclosures.
CBC values linked to CVD risk in psoriasis
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
REPORTING FROM IID 2018
Key clinical point: Elevated red blood cell distribution width and mean platelet volume might identify psoriasis patients at risk for cardiovascular disease.
Major finding: The incidence of MI was highest among the 1,920 patients with elevated red cell distribution width and mean platelet volume (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001).
Study details: A database review of 39,510 patients with psoriasis.
Disclosures: The National Institutes of Health funded the work. The lead investigator had no disclosures to report.
Source: Conic R et al. IID 2018, Abstract 550.