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Burkholderia cepacia causes blood infection in older, sicker patients
Non–cystic fibrosis–related Burkholderia cepacia complex infections occurred almost exclusively in older hospitalized patients with serious comorbidities – and the majority were acquired in a health care setting, a large U.S. Veterans Health Administration database study has determined.
Despite the bacteria’s tendency to be multidrug-resistant, both fluoroquinolones and trimethoprim-sulfamethoxazole were equally effective, as long as they were promptly initiated, Nadim G. El Chakhtoura, MD, and colleagues reported (Clin Infect Dis, 2017. doi: 10.1093/cid/cix559).
“We consider that the approach to improve survival in B. cepacia complex (Bcc) bloodstream infections … should include controlling the source of infection and prompt initiation of effective antibiotic therapy,” wrote Dr. El Chakhtoura of Cleveland Hospitals University Medical Center, and associates.
They found 248 cases of Bcc blood infections among such patients. Most (98%) were older men (mean age 68 years) with serious chronic and acute illnesses. Diabetes was common (44%), as was hemodialysis (23%). Many (41%) had been on mechanical ventilation. The etiology of the infections reflected these clinical factors: Most (62%) were nosocomial, with 41% associated with a central venous line and 20% with pneumonia. Just 9% were community acquired, mostly associated with pneumonia and intravenous drug use.
About 85% of isolates underwent antibiotic susceptibility testing. Most (94%) were sensitive to sulfamethoxazole/trimethoprim and 88% to levofloxacin. The next best choices were ceftazidime (72%) and meropenem (69%), although the authors pointed out that only 32 isolates were tested for that drug. Of the 60 tested for ticarcillin-clavulanate, 6% were sensitive.
The authors pointed out that the approximate 30% resistance rate to ceftazidime was concerning and unexpected.
Empiric therapy was considered inappropriate in 35%, and definitive therapy inappropriate in 11%. Having an infectious disease specialist involved with the case increased the chance that it would be treated appropriately (75% vs. 57%). Mortality was 16% at 14 days, 25% at 30 days, and 36% at 90 days. Older age, higher Charlson comorbidity index, higher Pitt bacteremia scores, and prior antibiotic treatment were independently associated with an increased risk of death, the researchers said.
Although the VA database comprises mostly of males, the review spanned so many years and comprised such a large cohort that the findings can probably be accurately extrapolated to a general population of patients, Dr. El Chakhtoura and associates added.
Dr. El Chakhtoura had no relevant financial disclosures.
[email protected]
On Twitter @Alz_gal
Non–cystic fibrosis–related Burkholderia cepacia complex infections occurred almost exclusively in older hospitalized patients with serious comorbidities – and the majority were acquired in a health care setting, a large U.S. Veterans Health Administration database study has determined.
Despite the bacteria’s tendency to be multidrug-resistant, both fluoroquinolones and trimethoprim-sulfamethoxazole were equally effective, as long as they were promptly initiated, Nadim G. El Chakhtoura, MD, and colleagues reported (Clin Infect Dis, 2017. doi: 10.1093/cid/cix559).
“We consider that the approach to improve survival in B. cepacia complex (Bcc) bloodstream infections … should include controlling the source of infection and prompt initiation of effective antibiotic therapy,” wrote Dr. El Chakhtoura of Cleveland Hospitals University Medical Center, and associates.
They found 248 cases of Bcc blood infections among such patients. Most (98%) were older men (mean age 68 years) with serious chronic and acute illnesses. Diabetes was common (44%), as was hemodialysis (23%). Many (41%) had been on mechanical ventilation. The etiology of the infections reflected these clinical factors: Most (62%) were nosocomial, with 41% associated with a central venous line and 20% with pneumonia. Just 9% were community acquired, mostly associated with pneumonia and intravenous drug use.
About 85% of isolates underwent antibiotic susceptibility testing. Most (94%) were sensitive to sulfamethoxazole/trimethoprim and 88% to levofloxacin. The next best choices were ceftazidime (72%) and meropenem (69%), although the authors pointed out that only 32 isolates were tested for that drug. Of the 60 tested for ticarcillin-clavulanate, 6% were sensitive.
The authors pointed out that the approximate 30% resistance rate to ceftazidime was concerning and unexpected.
Empiric therapy was considered inappropriate in 35%, and definitive therapy inappropriate in 11%. Having an infectious disease specialist involved with the case increased the chance that it would be treated appropriately (75% vs. 57%). Mortality was 16% at 14 days, 25% at 30 days, and 36% at 90 days. Older age, higher Charlson comorbidity index, higher Pitt bacteremia scores, and prior antibiotic treatment were independently associated with an increased risk of death, the researchers said.
Although the VA database comprises mostly of males, the review spanned so many years and comprised such a large cohort that the findings can probably be accurately extrapolated to a general population of patients, Dr. El Chakhtoura and associates added.
Dr. El Chakhtoura had no relevant financial disclosures.
[email protected]
On Twitter @Alz_gal
Non–cystic fibrosis–related Burkholderia cepacia complex infections occurred almost exclusively in older hospitalized patients with serious comorbidities – and the majority were acquired in a health care setting, a large U.S. Veterans Health Administration database study has determined.
Despite the bacteria’s tendency to be multidrug-resistant, both fluoroquinolones and trimethoprim-sulfamethoxazole were equally effective, as long as they were promptly initiated, Nadim G. El Chakhtoura, MD, and colleagues reported (Clin Infect Dis, 2017. doi: 10.1093/cid/cix559).
“We consider that the approach to improve survival in B. cepacia complex (Bcc) bloodstream infections … should include controlling the source of infection and prompt initiation of effective antibiotic therapy,” wrote Dr. El Chakhtoura of Cleveland Hospitals University Medical Center, and associates.
They found 248 cases of Bcc blood infections among such patients. Most (98%) were older men (mean age 68 years) with serious chronic and acute illnesses. Diabetes was common (44%), as was hemodialysis (23%). Many (41%) had been on mechanical ventilation. The etiology of the infections reflected these clinical factors: Most (62%) were nosocomial, with 41% associated with a central venous line and 20% with pneumonia. Just 9% were community acquired, mostly associated with pneumonia and intravenous drug use.
About 85% of isolates underwent antibiotic susceptibility testing. Most (94%) were sensitive to sulfamethoxazole/trimethoprim and 88% to levofloxacin. The next best choices were ceftazidime (72%) and meropenem (69%), although the authors pointed out that only 32 isolates were tested for that drug. Of the 60 tested for ticarcillin-clavulanate, 6% were sensitive.
The authors pointed out that the approximate 30% resistance rate to ceftazidime was concerning and unexpected.
Empiric therapy was considered inappropriate in 35%, and definitive therapy inappropriate in 11%. Having an infectious disease specialist involved with the case increased the chance that it would be treated appropriately (75% vs. 57%). Mortality was 16% at 14 days, 25% at 30 days, and 36% at 90 days. Older age, higher Charlson comorbidity index, higher Pitt bacteremia scores, and prior antibiotic treatment were independently associated with an increased risk of death, the researchers said.
Although the VA database comprises mostly of males, the review spanned so many years and comprised such a large cohort that the findings can probably be accurately extrapolated to a general population of patients, Dr. El Chakhtoura and associates added.
Dr. El Chakhtoura had no relevant financial disclosures.
[email protected]
On Twitter @Alz_gal
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point:
Major finding: Most infections were nosocomial (61%); 94% were susceptible to sulfamethoxazole/trimethoprim.
Data source: The 16-year review found 248 cases in patients without cystic fibrosis.
Disclosures: Dr. El Chakhtoura had no relevant financial disclosures.
Endo removes Opana ER from market
Even as it defended the product’s safety when appropriately used, Endo International withdrew from the market its long-acting opioid agonist Opana ER, in compliance with a June 8 Food and Drug Administration request. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” according to a news release posted on Endo’s website. “Nevertheless, after careful consideration and consultation with the FDA following [its] June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”
In fact, the data showed a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a thrombotic microangiopathy.
Endo said it will work with FDA to coordinate a smooth removal of the product, and insisted that the drug is safe and effective.
“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012, with the intent of making it “resistant to physical and chemical manipulation for abuse by snorting or injecting,” according to the FDA release.
On Twitter @Alz_gal
Even as it defended the product’s safety when appropriately used, Endo International withdrew from the market its long-acting opioid agonist Opana ER, in compliance with a June 8 Food and Drug Administration request. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” according to a news release posted on Endo’s website. “Nevertheless, after careful consideration and consultation with the FDA following [its] June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”
In fact, the data showed a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a thrombotic microangiopathy.
Endo said it will work with FDA to coordinate a smooth removal of the product, and insisted that the drug is safe and effective.
“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012, with the intent of making it “resistant to physical and chemical manipulation for abuse by snorting or injecting,” according to the FDA release.
On Twitter @Alz_gal
Even as it defended the product’s safety when appropriately used, Endo International withdrew from the market its long-acting opioid agonist Opana ER, in compliance with a June 8 Food and Drug Administration request. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” according to a news release posted on Endo’s website. “Nevertheless, after careful consideration and consultation with the FDA following [its] June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”
In fact, the data showed a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a thrombotic microangiopathy.
Endo said it will work with FDA to coordinate a smooth removal of the product, and insisted that the drug is safe and effective.
“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012, with the intent of making it “resistant to physical and chemical manipulation for abuse by snorting or injecting,” according to the FDA release.
On Twitter @Alz_gal
Savolitinib improves PFS in some with MET-driven papillary renal cell carcinoma
Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, improved progression-free survival in a small portion of patients with MET-driven advanced renal papillary cell cancer.
The molecule, being developed by Hutchison China MediTech Limited and AstraZeneca, extended progression-free survival by about 5 months in these patients, compared with those whose tumors were not MET driven (6.2 vs. 1.4 months, respectively), reported Toni Choueiri, MD, and his colleagues (J Clin Oncol 2017. doi: 10.1200/JCO.2017.72.2967).
Of 109 patients in the phase II study, 44 (40%) had MET-driven disease. The cancer was MET independent in 46 (42%); MET status was unknown in the remainder.
Half of those with MET-driven tumors experienced stable disease, and 61% experienced tumor shrinkage ranging from 0.7% to 66%. Tumor shrinkage occurred in 20% of those with MET-independent tumors. These also responded less vigorously (shrinkage 0.5%-20%).
Of the eight patients exhibiting a partial response, six were still responding to treatment at the study’s end, with response ranging from 2 to 16 months. Two patients experienced progressive disease after 1.8 and 2.8 months. By the end of the study, disease progression had occurred in 75% of the MET-driven cases, 96% of the MET-independent cases, and 74% of cases whose MET status was unknown.
“These results confirm that savolitinib … holds promise as a personalized treatment for patients with metastatic MET-driven papillary renal cell carcinoma,” the investigators wrote. The data also support the June launch of the phase III SAVOIR trial, they noted.
SAVOIR will enroll about 180 patients with MET-driven renal papillary cancer confirmed by a next-generation molecular sequencing developed by the companies for savolitinib response. Patients will be randomized to continuous treatment with savolitinib 600 mg orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.
Dr. Choueiri has been a consultant for and received research funding from numerous pharmaceutical companies, including AstraZeneca.
[email protected]
On Twitter @Alz_gal
Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, improved progression-free survival in a small portion of patients with MET-driven advanced renal papillary cell cancer.
The molecule, being developed by Hutchison China MediTech Limited and AstraZeneca, extended progression-free survival by about 5 months in these patients, compared with those whose tumors were not MET driven (6.2 vs. 1.4 months, respectively), reported Toni Choueiri, MD, and his colleagues (J Clin Oncol 2017. doi: 10.1200/JCO.2017.72.2967).
Of 109 patients in the phase II study, 44 (40%) had MET-driven disease. The cancer was MET independent in 46 (42%); MET status was unknown in the remainder.
Half of those with MET-driven tumors experienced stable disease, and 61% experienced tumor shrinkage ranging from 0.7% to 66%. Tumor shrinkage occurred in 20% of those with MET-independent tumors. These also responded less vigorously (shrinkage 0.5%-20%).
Of the eight patients exhibiting a partial response, six were still responding to treatment at the study’s end, with response ranging from 2 to 16 months. Two patients experienced progressive disease after 1.8 and 2.8 months. By the end of the study, disease progression had occurred in 75% of the MET-driven cases, 96% of the MET-independent cases, and 74% of cases whose MET status was unknown.
“These results confirm that savolitinib … holds promise as a personalized treatment for patients with metastatic MET-driven papillary renal cell carcinoma,” the investigators wrote. The data also support the June launch of the phase III SAVOIR trial, they noted.
SAVOIR will enroll about 180 patients with MET-driven renal papillary cancer confirmed by a next-generation molecular sequencing developed by the companies for savolitinib response. Patients will be randomized to continuous treatment with savolitinib 600 mg orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.
Dr. Choueiri has been a consultant for and received research funding from numerous pharmaceutical companies, including AstraZeneca.
[email protected]
On Twitter @Alz_gal
Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, improved progression-free survival in a small portion of patients with MET-driven advanced renal papillary cell cancer.
The molecule, being developed by Hutchison China MediTech Limited and AstraZeneca, extended progression-free survival by about 5 months in these patients, compared with those whose tumors were not MET driven (6.2 vs. 1.4 months, respectively), reported Toni Choueiri, MD, and his colleagues (J Clin Oncol 2017. doi: 10.1200/JCO.2017.72.2967).
Of 109 patients in the phase II study, 44 (40%) had MET-driven disease. The cancer was MET independent in 46 (42%); MET status was unknown in the remainder.
Half of those with MET-driven tumors experienced stable disease, and 61% experienced tumor shrinkage ranging from 0.7% to 66%. Tumor shrinkage occurred in 20% of those with MET-independent tumors. These also responded less vigorously (shrinkage 0.5%-20%).
Of the eight patients exhibiting a partial response, six were still responding to treatment at the study’s end, with response ranging from 2 to 16 months. Two patients experienced progressive disease after 1.8 and 2.8 months. By the end of the study, disease progression had occurred in 75% of the MET-driven cases, 96% of the MET-independent cases, and 74% of cases whose MET status was unknown.
“These results confirm that savolitinib … holds promise as a personalized treatment for patients with metastatic MET-driven papillary renal cell carcinoma,” the investigators wrote. The data also support the June launch of the phase III SAVOIR trial, they noted.
SAVOIR will enroll about 180 patients with MET-driven renal papillary cancer confirmed by a next-generation molecular sequencing developed by the companies for savolitinib response. Patients will be randomized to continuous treatment with savolitinib 600 mg orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.
Dr. Choueiri has been a consultant for and received research funding from numerous pharmaceutical companies, including AstraZeneca.
[email protected]
On Twitter @Alz_gal
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: A partial response occurred in 18% of these patients, who gained about 5 months of progression-free disease compared with those with MET-independent tumors.
Data source: A phase II trial comprising 109 patients.
Disclosures: Dr. Choueiri has been a consultant for and received research funds from AstraZeneca, which is developing the drug.
Meta-analysis: Bisphosphonates mitigate glucocorticoid-induced bone loss
MADRID – Bisphosphonates mitigate the damaging effects of glucocorticoid on bone, boosting bone mineral density and reducing the risk of fracture by up to 33%, compared with placebo, according to a systematic review and meta-analysis.
The review of 11 randomized, controlled trials found that bisphosphonates consistently improved bone outcomes among patients taking prednisone, Anas Makhzoum, MD, said at the European Congress of Rheumatology.
The primary outcomes of these trials were mean percentage change in bone mineral density at lumbar spine and femoral neck, and fracture incidence.
The drugs examined were ibandronate, alendronate, risedronate, etidronate, and clodronate. The mean duration of these trials was 71 weeks. Patients took a mean steroid dose of 15 mg.
Dr. Makhzoum, a resident at Queen’s University, Kingston, Ont., pooled nine of these trials for the outcome of mean percentage change in lumbar spine bone mineral density. The pooled mean percentage change of lumbar spine consistently favored bisphosphonates, compared with placebo, with a mean, statistically significant difference of approximately 4%.
Six studies were pooled for the outcome of mean percentage change in femoral neck bone mineral density. The pooled mean percentage change consistently favored bisphosphonates, with a mean, statistically significant difference of 2.95% relative to placebo.
Seven studies were pooled for outcome of incident fracture and the results consistently favored bisphosphonates, with a mean, statistically significant 33% decrease in the risk of a new fracture, compared with the placebo group (relative risk, 0.66).
“Bisphosphonates remain the standard of care for prevention and treatment of bone loss in patients on chronic steroids treatment,” Dr. Makhzoum noted.
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
MADRID – Bisphosphonates mitigate the damaging effects of glucocorticoid on bone, boosting bone mineral density and reducing the risk of fracture by up to 33%, compared with placebo, according to a systematic review and meta-analysis.
The review of 11 randomized, controlled trials found that bisphosphonates consistently improved bone outcomes among patients taking prednisone, Anas Makhzoum, MD, said at the European Congress of Rheumatology.
The primary outcomes of these trials were mean percentage change in bone mineral density at lumbar spine and femoral neck, and fracture incidence.
The drugs examined were ibandronate, alendronate, risedronate, etidronate, and clodronate. The mean duration of these trials was 71 weeks. Patients took a mean steroid dose of 15 mg.
Dr. Makhzoum, a resident at Queen’s University, Kingston, Ont., pooled nine of these trials for the outcome of mean percentage change in lumbar spine bone mineral density. The pooled mean percentage change of lumbar spine consistently favored bisphosphonates, compared with placebo, with a mean, statistically significant difference of approximately 4%.
Six studies were pooled for the outcome of mean percentage change in femoral neck bone mineral density. The pooled mean percentage change consistently favored bisphosphonates, with a mean, statistically significant difference of 2.95% relative to placebo.
Seven studies were pooled for outcome of incident fracture and the results consistently favored bisphosphonates, with a mean, statistically significant 33% decrease in the risk of a new fracture, compared with the placebo group (relative risk, 0.66).
“Bisphosphonates remain the standard of care for prevention and treatment of bone loss in patients on chronic steroids treatment,” Dr. Makhzoum noted.
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
MADRID – Bisphosphonates mitigate the damaging effects of glucocorticoid on bone, boosting bone mineral density and reducing the risk of fracture by up to 33%, compared with placebo, according to a systematic review and meta-analysis.
The review of 11 randomized, controlled trials found that bisphosphonates consistently improved bone outcomes among patients taking prednisone, Anas Makhzoum, MD, said at the European Congress of Rheumatology.
The primary outcomes of these trials were mean percentage change in bone mineral density at lumbar spine and femoral neck, and fracture incidence.
The drugs examined were ibandronate, alendronate, risedronate, etidronate, and clodronate. The mean duration of these trials was 71 weeks. Patients took a mean steroid dose of 15 mg.
Dr. Makhzoum, a resident at Queen’s University, Kingston, Ont., pooled nine of these trials for the outcome of mean percentage change in lumbar spine bone mineral density. The pooled mean percentage change of lumbar spine consistently favored bisphosphonates, compared with placebo, with a mean, statistically significant difference of approximately 4%.
Six studies were pooled for the outcome of mean percentage change in femoral neck bone mineral density. The pooled mean percentage change consistently favored bisphosphonates, with a mean, statistically significant difference of 2.95% relative to placebo.
Seven studies were pooled for outcome of incident fracture and the results consistently favored bisphosphonates, with a mean, statistically significant 33% decrease in the risk of a new fracture, compared with the placebo group (relative risk, 0.66).
“Bisphosphonates remain the standard of care for prevention and treatment of bone loss in patients on chronic steroids treatment,” Dr. Makhzoum noted.
He had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Relative to placebo, bisphosphonates reduced the risk of fracture by up to 33%.
Data source: A meta-analysis comprising 11 randomized, placebo-controlled trials with more than 2,000 patients.
Disclosures: Dr. Makhzoum had no financial disclosures.
Early phase III data positive for adalimumab biosimilar, for both psoriasis and PsA
MADRID – To date, an adalimumab biosimilar has proven itself in a large, phase III trial of patients with psoriasis, including a subset with mild to moderate psoriatic arthritis (PsA).
The biosimilar, known as CHS-1420, cleared psoriatic plaques and improved health-related quality of life just as well as adalimumab after 12 weeks of treatment, Barbara Finck, MD, said at the European Congress of Rheumatology. It also suppressed high-sensitivity C-reactive protein (CRP) as well as the originator molecule, she said.
Dr. Finck, the chief medical officer of Coherus Biosciences, the developer of CHS-1420, reported results from the first 16-week phase of the 48-week study. Data are still to come on a 6-week period during which half those taking adalimumab switched to CHS-1420 in a blinded fashion, and 26 weeks of open-label CHS-1420 for all patients.
The study’s primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) Two additional endpoints were evaluated in patients with PsA: change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and changes in CRP.
Dr. Finck bemoaned the lack of the clinical rheumatologic endpoint, tender and swollen joint count. “I advocated for this but was unable to convince our dermatology colleagues” to conduct this exam, she said. “I think we have a ways to go to educate our colleagues in this regard.”
The study comprised 545 patients with mild to moderate psoriasis; of these, 127 had PsA. They received subcutaneous injections of either CHS-1420 or adalimumab at identical doses (80 mg at week 1, followed by 40 mg every other week). They were a mean of 44 years o_web.jpg)
In the entire study population, treatment with CHS-1420 and adalimumab followed almost identical response curves. By week 4, 22% of the CHS-1420 group and 20% of the adalimumab group had reached a PASI75 response. By week 8, those numbers were 57% and 61%, respectively, and by week 12, they were 69% and 72% – not significantly different.
Response was similar in the subgroup of PsA patients: By week 12, 82% of the CHS-1420 group and 77% of the adalimumab group had reached a PASI 75. PsA patients also responded equally well to both medications on the HAQ-DI by week 12. At baseline, the mean HAQ-DI was about 1 in each group. At 12 weeks, it was reduced by about half a point in both groups. High-sensitivity CRP decreased similarly in the CHS-1420 and adalimumab groups as well (reductions of 8.9 mg/L and 6.3 mg/L, respectively).
Adalimumab, a tumor necrosis factor blocker, is a highly immunogenic molecule, and as such, many patients developed antibodies to both it and to CHS-1420. By week 12, 84% of both treatment groups had developed anti-drug antibodies and 32%, neutralizing antibodies. Among those with PsA, 82% taking CHS-1420 and 88% of those taking adalimumab developed antidrug antibodies. Neutralizing antibodies developed in 33% and 30%, respectively. Neither of these differences was statistically significant.
Other adverse events were similar, Dr. Finck noted. These included nasopharyngitis (9% of both groups), upper respiratory tract infection (6%), injection site reaction (4%), headache (3%), and worsening of psoriasis (1% for CHS-1420, and 3% for adalimumab).
If the switching study data are similarly positive, Coherus expects to file a Biologics License Application with the Food and Drug Administration in early 2018, Dr. Finck said.
[email protected]
On Twitter @Alz_gal
MADRID – To date, an adalimumab biosimilar has proven itself in a large, phase III trial of patients with psoriasis, including a subset with mild to moderate psoriatic arthritis (PsA).
The biosimilar, known as CHS-1420, cleared psoriatic plaques and improved health-related quality of life just as well as adalimumab after 12 weeks of treatment, Barbara Finck, MD, said at the European Congress of Rheumatology. It also suppressed high-sensitivity C-reactive protein (CRP) as well as the originator molecule, she said.
Dr. Finck, the chief medical officer of Coherus Biosciences, the developer of CHS-1420, reported results from the first 16-week phase of the 48-week study. Data are still to come on a 6-week period during which half those taking adalimumab switched to CHS-1420 in a blinded fashion, and 26 weeks of open-label CHS-1420 for all patients.
The study’s primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) Two additional endpoints were evaluated in patients with PsA: change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and changes in CRP.
Dr. Finck bemoaned the lack of the clinical rheumatologic endpoint, tender and swollen joint count. “I advocated for this but was unable to convince our dermatology colleagues” to conduct this exam, she said. “I think we have a ways to go to educate our colleagues in this regard.”
The study comprised 545 patients with mild to moderate psoriasis; of these, 127 had PsA. They received subcutaneous injections of either CHS-1420 or adalimumab at identical doses (80 mg at week 1, followed by 40 mg every other week). They were a mean of 44 years o
In the entire study population, treatment with CHS-1420 and adalimumab followed almost identical response curves. By week 4, 22% of the CHS-1420 group and 20% of the adalimumab group had reached a PASI75 response. By week 8, those numbers were 57% and 61%, respectively, and by week 12, they were 69% and 72% – not significantly different.
Response was similar in the subgroup of PsA patients: By week 12, 82% of the CHS-1420 group and 77% of the adalimumab group had reached a PASI 75. PsA patients also responded equally well to both medications on the HAQ-DI by week 12. At baseline, the mean HAQ-DI was about 1 in each group. At 12 weeks, it was reduced by about half a point in both groups. High-sensitivity CRP decreased similarly in the CHS-1420 and adalimumab groups as well (reductions of 8.9 mg/L and 6.3 mg/L, respectively).
Adalimumab, a tumor necrosis factor blocker, is a highly immunogenic molecule, and as such, many patients developed antibodies to both it and to CHS-1420. By week 12, 84% of both treatment groups had developed anti-drug antibodies and 32%, neutralizing antibodies. Among those with PsA, 82% taking CHS-1420 and 88% of those taking adalimumab developed antidrug antibodies. Neutralizing antibodies developed in 33% and 30%, respectively. Neither of these differences was statistically significant.
Other adverse events were similar, Dr. Finck noted. These included nasopharyngitis (9% of both groups), upper respiratory tract infection (6%), injection site reaction (4%), headache (3%), and worsening of psoriasis (1% for CHS-1420, and 3% for adalimumab).
If the switching study data are similarly positive, Coherus expects to file a Biologics License Application with the Food and Drug Administration in early 2018, Dr. Finck said.
[email protected]
On Twitter @Alz_gal
MADRID – To date, an adalimumab biosimilar has proven itself in a large, phase III trial of patients with psoriasis, including a subset with mild to moderate psoriatic arthritis (PsA).
The biosimilar, known as CHS-1420, cleared psoriatic plaques and improved health-related quality of life just as well as adalimumab after 12 weeks of treatment, Barbara Finck, MD, said at the European Congress of Rheumatology. It also suppressed high-sensitivity C-reactive protein (CRP) as well as the originator molecule, she said.
Dr. Finck, the chief medical officer of Coherus Biosciences, the developer of CHS-1420, reported results from the first 16-week phase of the 48-week study. Data are still to come on a 6-week period during which half those taking adalimumab switched to CHS-1420 in a blinded fashion, and 26 weeks of open-label CHS-1420 for all patients.
The study’s primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) Two additional endpoints were evaluated in patients with PsA: change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and changes in CRP.
Dr. Finck bemoaned the lack of the clinical rheumatologic endpoint, tender and swollen joint count. “I advocated for this but was unable to convince our dermatology colleagues” to conduct this exam, she said. “I think we have a ways to go to educate our colleagues in this regard.”
The study comprised 545 patients with mild to moderate psoriasis; of these, 127 had PsA. They received subcutaneous injections of either CHS-1420 or adalimumab at identical doses (80 mg at week 1, followed by 40 mg every other week). They were a mean of 44 years o
In the entire study population, treatment with CHS-1420 and adalimumab followed almost identical response curves. By week 4, 22% of the CHS-1420 group and 20% of the adalimumab group had reached a PASI75 response. By week 8, those numbers were 57% and 61%, respectively, and by week 12, they were 69% and 72% – not significantly different.
Response was similar in the subgroup of PsA patients: By week 12, 82% of the CHS-1420 group and 77% of the adalimumab group had reached a PASI 75. PsA patients also responded equally well to both medications on the HAQ-DI by week 12. At baseline, the mean HAQ-DI was about 1 in each group. At 12 weeks, it was reduced by about half a point in both groups. High-sensitivity CRP decreased similarly in the CHS-1420 and adalimumab groups as well (reductions of 8.9 mg/L and 6.3 mg/L, respectively).
Adalimumab, a tumor necrosis factor blocker, is a highly immunogenic molecule, and as such, many patients developed antibodies to both it and to CHS-1420. By week 12, 84% of both treatment groups had developed anti-drug antibodies and 32%, neutralizing antibodies. Among those with PsA, 82% taking CHS-1420 and 88% of those taking adalimumab developed antidrug antibodies. Neutralizing antibodies developed in 33% and 30%, respectively. Neither of these differences was statistically significant.
Other adverse events were similar, Dr. Finck noted. These included nasopharyngitis (9% of both groups), upper respiratory tract infection (6%), injection site reaction (4%), headache (3%), and worsening of psoriasis (1% for CHS-1420, and 3% for adalimumab).
If the switching study data are similarly positive, Coherus expects to file a Biologics License Application with the Food and Drug Administration in early 2018, Dr. Finck said.
[email protected]
On Twitter @Alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: By week 12, 69% of those who received CHS-1420 and 72% of those who received adalimumab had reached a PASI75, response rates that were not significantly different.
Data source: The phase III trial randomized 545 patients with psoriasis, including 127 with PsA, to treatment with adalimumab or the biosimilar.
Disclosures: Dr. Finck is chief medical officer of Coherus Biosciences, which is developing CHS-1420.
IL-6 nanobody vobarilizumab advances despite equivocal phase II data
MADRID – Despite failing its phase II primary endpoint, the single-domain antibody vobarilizumab, being developed for rheumatoid arthritis, will advance to phase III studies.
A robust placebo response obscured the strength of clinical response to vobarilizumab, a nanobody that blocks the soluble interleukin-6 receptor, Thomas Dorner, MD, said at the European Congress of Rheumatology. But by 24 weeks of treatment, vobarilizumab effected a deep, sustained response in up to half of patients with rheumatoid arthritis who responded inadequately to methotrexate.
The safety profile was encouraging, Dr. Dorner said, with just one case of gastrointestinal perforation. These events have been a problem in some IL-6 blockade studies; the protein stimulates repair of the intestinal epithelium and blocking it leaves the tissue vulnerable to injury. The single case in this trial occurred 17 days after the patient withdrew from the study for other reasons, so it was not considered to be related to the study medication, Dr. Dorner said.
Vobarilizumab is composed of two heavy chains, lacking the two light-chain arms of a full antibody. It is minuscule – just 10% of the molecular weight of a conventional antibody. One chain targets human serum albumin and is designed to prolong the molecule’s half-life by up to 14 days; the other chain targets the soluble IL-6 receptor.
The phase IIb study comprised 345 patients with active RA despite treatment with methotrexate (mean dose 16 mg/week). While staying on their methotrexate, they were equally assigned to five treatment groups: placebo or vobarilizumab at 75 mg every 4 weeks; 150 mg every 4 weeks; 150 mg every 2 weeks; or 225 mg every 2 weeks.
The primary endpoint was the difference in ACR20 response at week 12 between placebo and the four dosing groups. While the majority of patients taking vobarilizumab met that endpoint, the percentages did not significantly differ from each other, nor from placebo. ACR20 was met by 62% of the placebo group and 81%-72% of the vobarilizumab groups. ACR50 was met by 28% of the placebo group and 45%-29% of the vobarilizumab groups and ACR70 by 9% of the placebo group and 21%-14% of the vobarilizumab groups.
However, Dr. Dorner said, response in the placebo group tended to tail off as the study progressed, while staying significantly stronger in the higher-dose vobarilizumab groups. By week 24, 16% of the placebo group still had an ACR50 – significantly less than in the vobarilizumab 150 mg/2 weeks and 225 mg/2 weeks groups (31%, 39%, respectively).
On a measure of remission that combined C-reactive protein of less than 2.6 mg/L and low disease activity, vobarilizumab looked much better at week 24. At that point, 16% of placebo patients met the endpoint, compared to 39% of the 150 mg/4 weeks and 150 mg/2 weeks vobarilizumab groups, and 51% of the 225 mg/2 weeks group.
Adverse events occurred in 36% of placebo patients and about 44% of vobarilizumab patients and did not show any dose-response relationship. About 38% of these were considered treatment related; 7% of the cohort withdrew due to an adverse event. There were seven serious infections among those taking vobarilizumab (three pneumonia, and one each herpes zoster, ear infection, staphylococcus sepsis, and bacterial arthritis). One patient died of a myocardial infarction, but she had experienced a previous heart attack and undergone percutaneous coronary intervention. The single gastrointestinal perforation occurred in a woman taking the highest dose of vobarilizumab, more than 2 weeks after she stopped taking it.
Vobarilizumab will continue into a phase III study, according to the Ablynx website. The company is seeking an industry partner. AbbVie had an option to license vobarilizumab, but declined last fall on the mixed results of Ablynx’s phase II studies.
[email protected]
On Twitter @Alz_gal
MADRID – Despite failing its phase II primary endpoint, the single-domain antibody vobarilizumab, being developed for rheumatoid arthritis, will advance to phase III studies.
A robust placebo response obscured the strength of clinical response to vobarilizumab, a nanobody that blocks the soluble interleukin-6 receptor, Thomas Dorner, MD, said at the European Congress of Rheumatology. But by 24 weeks of treatment, vobarilizumab effected a deep, sustained response in up to half of patients with rheumatoid arthritis who responded inadequately to methotrexate.
The safety profile was encouraging, Dr. Dorner said, with just one case of gastrointestinal perforation. These events have been a problem in some IL-6 blockade studies; the protein stimulates repair of the intestinal epithelium and blocking it leaves the tissue vulnerable to injury. The single case in this trial occurred 17 days after the patient withdrew from the study for other reasons, so it was not considered to be related to the study medication, Dr. Dorner said.
Vobarilizumab is composed of two heavy chains, lacking the two light-chain arms of a full antibody. It is minuscule – just 10% of the molecular weight of a conventional antibody. One chain targets human serum albumin and is designed to prolong the molecule’s half-life by up to 14 days; the other chain targets the soluble IL-6 receptor.
The phase IIb study comprised 345 patients with active RA despite treatment with methotrexate (mean dose 16 mg/week). While staying on their methotrexate, they were equally assigned to five treatment groups: placebo or vobarilizumab at 75 mg every 4 weeks; 150 mg every 4 weeks; 150 mg every 2 weeks; or 225 mg every 2 weeks.
The primary endpoint was the difference in ACR20 response at week 12 between placebo and the four dosing groups. While the majority of patients taking vobarilizumab met that endpoint, the percentages did not significantly differ from each other, nor from placebo. ACR20 was met by 62% of the placebo group and 81%-72% of the vobarilizumab groups. ACR50 was met by 28% of the placebo group and 45%-29% of the vobarilizumab groups and ACR70 by 9% of the placebo group and 21%-14% of the vobarilizumab groups.
However, Dr. Dorner said, response in the placebo group tended to tail off as the study progressed, while staying significantly stronger in the higher-dose vobarilizumab groups. By week 24, 16% of the placebo group still had an ACR50 – significantly less than in the vobarilizumab 150 mg/2 weeks and 225 mg/2 weeks groups (31%, 39%, respectively).
On a measure of remission that combined C-reactive protein of less than 2.6 mg/L and low disease activity, vobarilizumab looked much better at week 24. At that point, 16% of placebo patients met the endpoint, compared to 39% of the 150 mg/4 weeks and 150 mg/2 weeks vobarilizumab groups, and 51% of the 225 mg/2 weeks group.
Adverse events occurred in 36% of placebo patients and about 44% of vobarilizumab patients and did not show any dose-response relationship. About 38% of these were considered treatment related; 7% of the cohort withdrew due to an adverse event. There were seven serious infections among those taking vobarilizumab (three pneumonia, and one each herpes zoster, ear infection, staphylococcus sepsis, and bacterial arthritis). One patient died of a myocardial infarction, but she had experienced a previous heart attack and undergone percutaneous coronary intervention. The single gastrointestinal perforation occurred in a woman taking the highest dose of vobarilizumab, more than 2 weeks after she stopped taking it.
Vobarilizumab will continue into a phase III study, according to the Ablynx website. The company is seeking an industry partner. AbbVie had an option to license vobarilizumab, but declined last fall on the mixed results of Ablynx’s phase II studies.
[email protected]
On Twitter @Alz_gal
MADRID – Despite failing its phase II primary endpoint, the single-domain antibody vobarilizumab, being developed for rheumatoid arthritis, will advance to phase III studies.
A robust placebo response obscured the strength of clinical response to vobarilizumab, a nanobody that blocks the soluble interleukin-6 receptor, Thomas Dorner, MD, said at the European Congress of Rheumatology. But by 24 weeks of treatment, vobarilizumab effected a deep, sustained response in up to half of patients with rheumatoid arthritis who responded inadequately to methotrexate.
The safety profile was encouraging, Dr. Dorner said, with just one case of gastrointestinal perforation. These events have been a problem in some IL-6 blockade studies; the protein stimulates repair of the intestinal epithelium and blocking it leaves the tissue vulnerable to injury. The single case in this trial occurred 17 days after the patient withdrew from the study for other reasons, so it was not considered to be related to the study medication, Dr. Dorner said.
Vobarilizumab is composed of two heavy chains, lacking the two light-chain arms of a full antibody. It is minuscule – just 10% of the molecular weight of a conventional antibody. One chain targets human serum albumin and is designed to prolong the molecule’s half-life by up to 14 days; the other chain targets the soluble IL-6 receptor.
The phase IIb study comprised 345 patients with active RA despite treatment with methotrexate (mean dose 16 mg/week). While staying on their methotrexate, they were equally assigned to five treatment groups: placebo or vobarilizumab at 75 mg every 4 weeks; 150 mg every 4 weeks; 150 mg every 2 weeks; or 225 mg every 2 weeks.
The primary endpoint was the difference in ACR20 response at week 12 between placebo and the four dosing groups. While the majority of patients taking vobarilizumab met that endpoint, the percentages did not significantly differ from each other, nor from placebo. ACR20 was met by 62% of the placebo group and 81%-72% of the vobarilizumab groups. ACR50 was met by 28% of the placebo group and 45%-29% of the vobarilizumab groups and ACR70 by 9% of the placebo group and 21%-14% of the vobarilizumab groups.
However, Dr. Dorner said, response in the placebo group tended to tail off as the study progressed, while staying significantly stronger in the higher-dose vobarilizumab groups. By week 24, 16% of the placebo group still had an ACR50 – significantly less than in the vobarilizumab 150 mg/2 weeks and 225 mg/2 weeks groups (31%, 39%, respectively).
On a measure of remission that combined C-reactive protein of less than 2.6 mg/L and low disease activity, vobarilizumab looked much better at week 24. At that point, 16% of placebo patients met the endpoint, compared to 39% of the 150 mg/4 weeks and 150 mg/2 weeks vobarilizumab groups, and 51% of the 225 mg/2 weeks group.
Adverse events occurred in 36% of placebo patients and about 44% of vobarilizumab patients and did not show any dose-response relationship. About 38% of these were considered treatment related; 7% of the cohort withdrew due to an adverse event. There were seven serious infections among those taking vobarilizumab (three pneumonia, and one each herpes zoster, ear infection, staphylococcus sepsis, and bacterial arthritis). One patient died of a myocardial infarction, but she had experienced a previous heart attack and undergone percutaneous coronary intervention. The single gastrointestinal perforation occurred in a woman taking the highest dose of vobarilizumab, more than 2 weeks after she stopped taking it.
Vobarilizumab will continue into a phase III study, according to the Ablynx website. The company is seeking an industry partner. AbbVie had an option to license vobarilizumab, but declined last fall on the mixed results of Ablynx’s phase II studies.
[email protected]
On Twitter @Alz_gal
AT EULAR 2017
Biologics, TNF-inhibitors confer no excess cancer risks upon RA patients
MADRID – Biologics and tumor necrosis factor–inhibitors confer very little – if any – risk of malignancy upon those who take them for rheumatoid arthritis, according to a large Swedish registry study.
A doubling in the risk of squamous cell carcinoma among those who took abatacept was the only significant finding in the 8-year study of almost 70,000 subjects, Hjalmar Wadstrom, said at the European Congress of Rheumatology. And while he said the finding could be spurious, he stressed that it can’t be ignored.
“We think this finding should be interpreted cautiously,” said Mr. Wadstrom, a doctoral student at the Karolinska Institute, Stockholm. “These patients are seen frequently, and this increase in sqaumous cell carcinoma could be related to this multiple screening, or due to study bias. But of course, we cannot disregard it. It should be validated and further examined.”
The study plumbed several national patient registries and administrative databases for its cohort. It comprised 22,500 patients who, from 2006 to 2014, took tocilizumab, abatacept, or rituximab; or a TNF-inhibitor as a first or second disease-modifying antirheumatic drug. These were compared to 46,600 patients who took synthetic DMARDS during the same period and to a matched general population cohort (107,500). The mean age of all groups was about 59 years.
The primary outcome was a first-ever solid or hematologic malignancy excluding nonmelanoma skin cancer. The fully adjusted risk model controlled for age, sex, educational level, comorbidities, seropositivity, number of hospitalizations and days spent in inpatient care, use of prednisone at baseline, use of nonsteroidal anti-inflammatory drugs at baseline, number of prescription drugs at baseline, and sick leave and disability.
A first invasive solid tumor or hematologic malignancy occurred in 50 patients taking tocilizumab; 61 taking abatacept; 141 taking rituximab; 478 taking a TNF-inhibitor as the first biologic DMARD; and 169 taking a TNF-inhibitor as the second DMARD. There was no statistically significant difference between any of these groups, when they were compared either to each other, to those taking a conventional synthetic DMARD, or to the general population.
The doubled risk of squamous cell carcinoma associated with abatacept (HR 2.2) was the only significant positive finding the secondary analysis, Dr. Wadstrom said.
He had no financial disclosures.
[email protected]
On Twitter @Alz_gal
MADRID – Biologics and tumor necrosis factor–inhibitors confer very little – if any – risk of malignancy upon those who take them for rheumatoid arthritis, according to a large Swedish registry study.
A doubling in the risk of squamous cell carcinoma among those who took abatacept was the only significant finding in the 8-year study of almost 70,000 subjects, Hjalmar Wadstrom, said at the European Congress of Rheumatology. And while he said the finding could be spurious, he stressed that it can’t be ignored.
“We think this finding should be interpreted cautiously,” said Mr. Wadstrom, a doctoral student at the Karolinska Institute, Stockholm. “These patients are seen frequently, and this increase in sqaumous cell carcinoma could be related to this multiple screening, or due to study bias. But of course, we cannot disregard it. It should be validated and further examined.”
The study plumbed several national patient registries and administrative databases for its cohort. It comprised 22,500 patients who, from 2006 to 2014, took tocilizumab, abatacept, or rituximab; or a TNF-inhibitor as a first or second disease-modifying antirheumatic drug. These were compared to 46,600 patients who took synthetic DMARDS during the same period and to a matched general population cohort (107,500). The mean age of all groups was about 59 years.
The primary outcome was a first-ever solid or hematologic malignancy excluding nonmelanoma skin cancer. The fully adjusted risk model controlled for age, sex, educational level, comorbidities, seropositivity, number of hospitalizations and days spent in inpatient care, use of prednisone at baseline, use of nonsteroidal anti-inflammatory drugs at baseline, number of prescription drugs at baseline, and sick leave and disability.
A first invasive solid tumor or hematologic malignancy occurred in 50 patients taking tocilizumab; 61 taking abatacept; 141 taking rituximab; 478 taking a TNF-inhibitor as the first biologic DMARD; and 169 taking a TNF-inhibitor as the second DMARD. There was no statistically significant difference between any of these groups, when they were compared either to each other, to those taking a conventional synthetic DMARD, or to the general population.
The doubled risk of squamous cell carcinoma associated with abatacept (HR 2.2) was the only significant positive finding the secondary analysis, Dr. Wadstrom said.
He had no financial disclosures.
[email protected]
On Twitter @Alz_gal
MADRID – Biologics and tumor necrosis factor–inhibitors confer very little – if any – risk of malignancy upon those who take them for rheumatoid arthritis, according to a large Swedish registry study.
A doubling in the risk of squamous cell carcinoma among those who took abatacept was the only significant finding in the 8-year study of almost 70,000 subjects, Hjalmar Wadstrom, said at the European Congress of Rheumatology. And while he said the finding could be spurious, he stressed that it can’t be ignored.
“We think this finding should be interpreted cautiously,” said Mr. Wadstrom, a doctoral student at the Karolinska Institute, Stockholm. “These patients are seen frequently, and this increase in sqaumous cell carcinoma could be related to this multiple screening, or due to study bias. But of course, we cannot disregard it. It should be validated and further examined.”
The study plumbed several national patient registries and administrative databases for its cohort. It comprised 22,500 patients who, from 2006 to 2014, took tocilizumab, abatacept, or rituximab; or a TNF-inhibitor as a first or second disease-modifying antirheumatic drug. These were compared to 46,600 patients who took synthetic DMARDS during the same period and to a matched general population cohort (107,500). The mean age of all groups was about 59 years.
The primary outcome was a first-ever solid or hematologic malignancy excluding nonmelanoma skin cancer. The fully adjusted risk model controlled for age, sex, educational level, comorbidities, seropositivity, number of hospitalizations and days spent in inpatient care, use of prednisone at baseline, use of nonsteroidal anti-inflammatory drugs at baseline, number of prescription drugs at baseline, and sick leave and disability.
A first invasive solid tumor or hematologic malignancy occurred in 50 patients taking tocilizumab; 61 taking abatacept; 141 taking rituximab; 478 taking a TNF-inhibitor as the first biologic DMARD; and 169 taking a TNF-inhibitor as the second DMARD. There was no statistically significant difference between any of these groups, when they were compared either to each other, to those taking a conventional synthetic DMARD, or to the general population.
The doubled risk of squamous cell carcinoma associated with abatacept (HR 2.2) was the only significant positive finding the secondary analysis, Dr. Wadstrom said.
He had no financial disclosures.
[email protected]
On Twitter @Alz_gal
AT EULAR 2017
Key clinical point:
Major finding: A twofold increased risk of squamous cell carcinoma was associated with abatacept.
Data source: The Swedish study examined almost 70,000 people in various national registries and health care databases.
Disclosures: Mr. Wadstrom had no financial disclosures.
Safety data review finds no increased risk of infection from abatacept
MADRID – Abatacept doesn’t appear to increase the risk of opportunistic infections among patients with rheumatoid arthritis, Kevin Winthrop, MD, reported at the European Congress of Rheumatology.
After reviewing all of the extant safety data on the drug – all of its clinical trial and open-label study data, and case reports of abatacept-associated adverse events – Dr. Winthrop concluded that infections, including tuberculosis, fungal overgrowth, herpes simplex and herpes zoster, occur either with similar frequency or less often than among those taking placebo.
“In fact, there is a sense that abatacept is actually safer,” than some other disease-modifying antirheumatic drugs,” said Dr. Winthrop, an infectious disease specialist at Oregon Health and Science University, Portland. However, there are few data comparing safety among the agents – something he said should be examined in more detail.
His review encompassed 16 clinical trials comprising 7,044 patients who took the drug (21,330 patient/years of abatacept exposure) and 1,485 patients who took placebo. He conducted two analyses: one for opportunistic bacterial and fungal infections, and one for herpes simplex and herpes zoster.
The first analysis found 45 opportunistic bacterial or fungal infections among those taking abatacept – an incidence rate of 0.21/ 100 person-years. There were seven such infections in the placebo group – an incidence rate of 0.56/100 person-years. This difference was statistically significant.
In the abatacept cohort, there were two cases of bronchopulmonary aspergilliosis (IR 0.01) and three fungal eye infections (IR 0.01). There was also one case of gastrointestinal candidiasis; one fungal esophagitis; one cryptococcal meningitis; two pneumonias (one pseudomonal and one caused by Pneumocystis jirovecii); and two cases of respiratory monoliasis. All of these infections had an incidence rate of less than 0.01/100 person-years.
There were 17 tuberculosis cases (IR 0.08/100 person-years). Three cases were latent. Six of the cases were pulmonary and five were extrapulmonary. Two cases were unspecified. All occurred in regions with high or moderate endemic tuberculosis levels.
A meta-regression analysis examined the risk of opportunistic infections in the patients taken from the placebo-controlled clinical trials only (2,653 abatacept, 1,485 placebo). The estimated frequency of an opportunistic infection was 0.15% among those taking the drug and 0.48% among those taking placebo.
The herpes analysis examined the placebo-controlled clinical trial population as well. There were 57 cases of herpes simplex (IR 2.5/100 person-years) among those taking abatacept and 22 among those taking placebo (IR 1.8/100 person-years). The difference was not statistically significant.
There were 44 cases of herpes zoster among those taking abatacept (IR 1.9/100 person-years) and 21 among those taking placebo (IR 1.7/100 person-years).
“Basically, I think what we’re seeing here is a whole lot of nothing,” Dr. Winthrop said.
Dr. Winthrop has been a consultant for Pfizer, AbbVie, Bristol-Myers Squibb, UCB Pharma, Roche/Genentech, Amgen, Galapagos, and Eli Lilly.
[email protected]
On Twitter @Alz_gal
MADRID – Abatacept doesn’t appear to increase the risk of opportunistic infections among patients with rheumatoid arthritis, Kevin Winthrop, MD, reported at the European Congress of Rheumatology.
After reviewing all of the extant safety data on the drug – all of its clinical trial and open-label study data, and case reports of abatacept-associated adverse events – Dr. Winthrop concluded that infections, including tuberculosis, fungal overgrowth, herpes simplex and herpes zoster, occur either with similar frequency or less often than among those taking placebo.
“In fact, there is a sense that abatacept is actually safer,” than some other disease-modifying antirheumatic drugs,” said Dr. Winthrop, an infectious disease specialist at Oregon Health and Science University, Portland. However, there are few data comparing safety among the agents – something he said should be examined in more detail.
His review encompassed 16 clinical trials comprising 7,044 patients who took the drug (21,330 patient/years of abatacept exposure) and 1,485 patients who took placebo. He conducted two analyses: one for opportunistic bacterial and fungal infections, and one for herpes simplex and herpes zoster.
The first analysis found 45 opportunistic bacterial or fungal infections among those taking abatacept – an incidence rate of 0.21/ 100 person-years. There were seven such infections in the placebo group – an incidence rate of 0.56/100 person-years. This difference was statistically significant.
In the abatacept cohort, there were two cases of bronchopulmonary aspergilliosis (IR 0.01) and three fungal eye infections (IR 0.01). There was also one case of gastrointestinal candidiasis; one fungal esophagitis; one cryptococcal meningitis; two pneumonias (one pseudomonal and one caused by Pneumocystis jirovecii); and two cases of respiratory monoliasis. All of these infections had an incidence rate of less than 0.01/100 person-years.
There were 17 tuberculosis cases (IR 0.08/100 person-years). Three cases were latent. Six of the cases were pulmonary and five were extrapulmonary. Two cases were unspecified. All occurred in regions with high or moderate endemic tuberculosis levels.
A meta-regression analysis examined the risk of opportunistic infections in the patients taken from the placebo-controlled clinical trials only (2,653 abatacept, 1,485 placebo). The estimated frequency of an opportunistic infection was 0.15% among those taking the drug and 0.48% among those taking placebo.
The herpes analysis examined the placebo-controlled clinical trial population as well. There were 57 cases of herpes simplex (IR 2.5/100 person-years) among those taking abatacept and 22 among those taking placebo (IR 1.8/100 person-years). The difference was not statistically significant.
There were 44 cases of herpes zoster among those taking abatacept (IR 1.9/100 person-years) and 21 among those taking placebo (IR 1.7/100 person-years).
“Basically, I think what we’re seeing here is a whole lot of nothing,” Dr. Winthrop said.
Dr. Winthrop has been a consultant for Pfizer, AbbVie, Bristol-Myers Squibb, UCB Pharma, Roche/Genentech, Amgen, Galapagos, and Eli Lilly.
[email protected]
On Twitter @Alz_gal
MADRID – Abatacept doesn’t appear to increase the risk of opportunistic infections among patients with rheumatoid arthritis, Kevin Winthrop, MD, reported at the European Congress of Rheumatology.
After reviewing all of the extant safety data on the drug – all of its clinical trial and open-label study data, and case reports of abatacept-associated adverse events – Dr. Winthrop concluded that infections, including tuberculosis, fungal overgrowth, herpes simplex and herpes zoster, occur either with similar frequency or less often than among those taking placebo.
“In fact, there is a sense that abatacept is actually safer,” than some other disease-modifying antirheumatic drugs,” said Dr. Winthrop, an infectious disease specialist at Oregon Health and Science University, Portland. However, there are few data comparing safety among the agents – something he said should be examined in more detail.
His review encompassed 16 clinical trials comprising 7,044 patients who took the drug (21,330 patient/years of abatacept exposure) and 1,485 patients who took placebo. He conducted two analyses: one for opportunistic bacterial and fungal infections, and one for herpes simplex and herpes zoster.
The first analysis found 45 opportunistic bacterial or fungal infections among those taking abatacept – an incidence rate of 0.21/ 100 person-years. There were seven such infections in the placebo group – an incidence rate of 0.56/100 person-years. This difference was statistically significant.
In the abatacept cohort, there were two cases of bronchopulmonary aspergilliosis (IR 0.01) and three fungal eye infections (IR 0.01). There was also one case of gastrointestinal candidiasis; one fungal esophagitis; one cryptococcal meningitis; two pneumonias (one pseudomonal and one caused by Pneumocystis jirovecii); and two cases of respiratory monoliasis. All of these infections had an incidence rate of less than 0.01/100 person-years.
There were 17 tuberculosis cases (IR 0.08/100 person-years). Three cases were latent. Six of the cases were pulmonary and five were extrapulmonary. Two cases were unspecified. All occurred in regions with high or moderate endemic tuberculosis levels.
A meta-regression analysis examined the risk of opportunistic infections in the patients taken from the placebo-controlled clinical trials only (2,653 abatacept, 1,485 placebo). The estimated frequency of an opportunistic infection was 0.15% among those taking the drug and 0.48% among those taking placebo.
The herpes analysis examined the placebo-controlled clinical trial population as well. There were 57 cases of herpes simplex (IR 2.5/100 person-years) among those taking abatacept and 22 among those taking placebo (IR 1.8/100 person-years). The difference was not statistically significant.
There were 44 cases of herpes zoster among those taking abatacept (IR 1.9/100 person-years) and 21 among those taking placebo (IR 1.7/100 person-years).
“Basically, I think what we’re seeing here is a whole lot of nothing,” Dr. Winthrop said.
Dr. Winthrop has been a consultant for Pfizer, AbbVie, Bristol-Myers Squibb, UCB Pharma, Roche/Genentech, Amgen, Galapagos, and Eli Lilly.
[email protected]
On Twitter @Alz_gal
AT EULAR 2017
Key clinical point:
Major finding: The overall incidence rate for opportunistic infection was 0.21/100 person-years for abatacept and 0.56 for placebo.
Data source: The review comprised 7,044 who took abatacept and 1,485 who took placebo.
Disclosures: Dr. Winthrop has been a consultant for Pfizer, AbbVie, Bristol-Myers Squibb, UCB Pharma, Roche/Genentech, Amgen, Galapagos, and Eli Lilly.
Apremilast eases PsA symptoms in patients who are naive to biologics
MADRID – Aprelimast rapidly improved symptoms for patients with active psoriatic arthritis who were naive to biologics, whether or not they were on background methotrexate.
Response to the phosphodiesterase 4-inhibitor also increased with time, Peter Nash, MD, said at the European Congress of Rheumatology. By 2 weeks, 16% had achieved an ACR20 response. By 24 weeks, that had risen to 43%, and at 52 weeks, was 67%. Many patients responded even better, with 37% achieving an ACR50 response and 21% and ACR70 response by the end of the phase III placebo-controlled trial, said Dr. Nash of the University of Queensland, Brisbane, Australia.
ACTIVE randomized 229 patients with active psoriatic arthritis (PsA) to either placebo or 30 mg apremilast twice daily. The primary endpoint was ACR20 response at week 16. At that time, patients who had not improved by at least 10% were offered early escape into active therapy.
Patients were a mean of 49 years old, with mean disease duration of 4 years. This is considerably shorter than the duration seen in many PsA trials, Dr. Nash said. It was a reflection of the study requirement that patients have taken no more than one synthetic disease-modifying antirheumatic agent (sDMARD) and no biologics for their disease.
The active and placebo groups separated very early in this study, with 16% of the apremilast group achieving an ACR 20 response by 2 weeks compared to 6% taking placebo. The response curves remained significantly separated throughout the entire study. By the 16-week endpoint, 38% of the active group and 20% of the placebo group had achieved ACR20. At this point, 11 of those taking apremilast asked for early escape and went on open-label apremilast at the same dose; 35 taking placebo were switched to open-label apremilast.
By 24 weeks, the ACR20 responses were 44% in the apremilast group and 25% in the placebo group. That response rate continued to rise over the year of treatment. By week 52, 67% of patients who had been on the study drug since the beginning had an ACR20, 37% an ACR50, and 21% an ACR70 response. ACR response was just as good in patients who were taking background methotrexate as those who were not, Dr. Nash said.
Compared to placebo, apremilast was associated with significantly more improvement on the Disease Activity Score-28 (CRP). Again, the response curves separated significantly by 2 weeks (–0.59 apremilast vs. –0.31 placebo) and continued to separate at 16 weeks (–1.07 vs. –0.39), and 24 weeks (–1.26 vs. –0.76). At 52 weeks, among those who had been initially randomized to apremilast, the mean DAS-28 (CRP) score had changed –1.71 from baseline.
The drug also significantly improved enthesitis relative to placebo, with rapid onset of action that continued to improve by week 24. The adverse event profile was good, Dr. Nash said. There were no opportunistic infections and no reactivations of tuberculosis. Ten in the active group and five in the placebo group withdrew due to an adverse event. Diarrhea and headache were the most common issues. Diarrhea occurred in 11% of the placebo group and 15% of the apremilast group; headache in 4% of the placebo group and 7% of the apremilast group. These were more common in the beginning of the study and tended to resolve with time, Dr. Nash said.
Thirty patients in the study had a history of depression and of these, two had a depression flare that lead to withdrawal from the study. Weight loss of at least 10% occurred in 5% of those taking apremilast.
Celgene sponsored the study. Dr. Nash has received research support from the company.
[email protected]
On Twitter @Alz_gal
MADRID – Aprelimast rapidly improved symptoms for patients with active psoriatic arthritis who were naive to biologics, whether or not they were on background methotrexate.
Response to the phosphodiesterase 4-inhibitor also increased with time, Peter Nash, MD, said at the European Congress of Rheumatology. By 2 weeks, 16% had achieved an ACR20 response. By 24 weeks, that had risen to 43%, and at 52 weeks, was 67%. Many patients responded even better, with 37% achieving an ACR50 response and 21% and ACR70 response by the end of the phase III placebo-controlled trial, said Dr. Nash of the University of Queensland, Brisbane, Australia.
ACTIVE randomized 229 patients with active psoriatic arthritis (PsA) to either placebo or 30 mg apremilast twice daily. The primary endpoint was ACR20 response at week 16. At that time, patients who had not improved by at least 10% were offered early escape into active therapy.
Patients were a mean of 49 years old, with mean disease duration of 4 years. This is considerably shorter than the duration seen in many PsA trials, Dr. Nash said. It was a reflection of the study requirement that patients have taken no more than one synthetic disease-modifying antirheumatic agent (sDMARD) and no biologics for their disease.
The active and placebo groups separated very early in this study, with 16% of the apremilast group achieving an ACR 20 response by 2 weeks compared to 6% taking placebo. The response curves remained significantly separated throughout the entire study. By the 16-week endpoint, 38% of the active group and 20% of the placebo group had achieved ACR20. At this point, 11 of those taking apremilast asked for early escape and went on open-label apremilast at the same dose; 35 taking placebo were switched to open-label apremilast.
By 24 weeks, the ACR20 responses were 44% in the apremilast group and 25% in the placebo group. That response rate continued to rise over the year of treatment. By week 52, 67% of patients who had been on the study drug since the beginning had an ACR20, 37% an ACR50, and 21% an ACR70 response. ACR response was just as good in patients who were taking background methotrexate as those who were not, Dr. Nash said.
Compared to placebo, apremilast was associated with significantly more improvement on the Disease Activity Score-28 (CRP). Again, the response curves separated significantly by 2 weeks (–0.59 apremilast vs. –0.31 placebo) and continued to separate at 16 weeks (–1.07 vs. –0.39), and 24 weeks (–1.26 vs. –0.76). At 52 weeks, among those who had been initially randomized to apremilast, the mean DAS-28 (CRP) score had changed –1.71 from baseline.
The drug also significantly improved enthesitis relative to placebo, with rapid onset of action that continued to improve by week 24. The adverse event profile was good, Dr. Nash said. There were no opportunistic infections and no reactivations of tuberculosis. Ten in the active group and five in the placebo group withdrew due to an adverse event. Diarrhea and headache were the most common issues. Diarrhea occurred in 11% of the placebo group and 15% of the apremilast group; headache in 4% of the placebo group and 7% of the apremilast group. These were more common in the beginning of the study and tended to resolve with time, Dr. Nash said.
Thirty patients in the study had a history of depression and of these, two had a depression flare that lead to withdrawal from the study. Weight loss of at least 10% occurred in 5% of those taking apremilast.
Celgene sponsored the study. Dr. Nash has received research support from the company.
[email protected]
On Twitter @Alz_gal
MADRID – Aprelimast rapidly improved symptoms for patients with active psoriatic arthritis who were naive to biologics, whether or not they were on background methotrexate.
Response to the phosphodiesterase 4-inhibitor also increased with time, Peter Nash, MD, said at the European Congress of Rheumatology. By 2 weeks, 16% had achieved an ACR20 response. By 24 weeks, that had risen to 43%, and at 52 weeks, was 67%. Many patients responded even better, with 37% achieving an ACR50 response and 21% and ACR70 response by the end of the phase III placebo-controlled trial, said Dr. Nash of the University of Queensland, Brisbane, Australia.
ACTIVE randomized 229 patients with active psoriatic arthritis (PsA) to either placebo or 30 mg apremilast twice daily. The primary endpoint was ACR20 response at week 16. At that time, patients who had not improved by at least 10% were offered early escape into active therapy.
Patients were a mean of 49 years old, with mean disease duration of 4 years. This is considerably shorter than the duration seen in many PsA trials, Dr. Nash said. It was a reflection of the study requirement that patients have taken no more than one synthetic disease-modifying antirheumatic agent (sDMARD) and no biologics for their disease.
The active and placebo groups separated very early in this study, with 16% of the apremilast group achieving an ACR 20 response by 2 weeks compared to 6% taking placebo. The response curves remained significantly separated throughout the entire study. By the 16-week endpoint, 38% of the active group and 20% of the placebo group had achieved ACR20. At this point, 11 of those taking apremilast asked for early escape and went on open-label apremilast at the same dose; 35 taking placebo were switched to open-label apremilast.
By 24 weeks, the ACR20 responses were 44% in the apremilast group and 25% in the placebo group. That response rate continued to rise over the year of treatment. By week 52, 67% of patients who had been on the study drug since the beginning had an ACR20, 37% an ACR50, and 21% an ACR70 response. ACR response was just as good in patients who were taking background methotrexate as those who were not, Dr. Nash said.
Compared to placebo, apremilast was associated with significantly more improvement on the Disease Activity Score-28 (CRP). Again, the response curves separated significantly by 2 weeks (–0.59 apremilast vs. –0.31 placebo) and continued to separate at 16 weeks (–1.07 vs. –0.39), and 24 weeks (–1.26 vs. –0.76). At 52 weeks, among those who had been initially randomized to apremilast, the mean DAS-28 (CRP) score had changed –1.71 from baseline.
The drug also significantly improved enthesitis relative to placebo, with rapid onset of action that continued to improve by week 24. The adverse event profile was good, Dr. Nash said. There were no opportunistic infections and no reactivations of tuberculosis. Ten in the active group and five in the placebo group withdrew due to an adverse event. Diarrhea and headache were the most common issues. Diarrhea occurred in 11% of the placebo group and 15% of the apremilast group; headache in 4% of the placebo group and 7% of the apremilast group. These were more common in the beginning of the study and tended to resolve with time, Dr. Nash said.
Thirty patients in the study had a history of depression and of these, two had a depression flare that lead to withdrawal from the study. Weight loss of at least 10% occurred in 5% of those taking apremilast.
Celgene sponsored the study. Dr. Nash has received research support from the company.
[email protected]
On Twitter @Alz_gal
AT EULAR 2017
Key clinical point: Apremilast improved symptoms of psoriatic arthritis in patients who were naive to biologics.
Major finding: By the 16-week endpoint, 38% of the active group and 20% of the placebo group had achieved ACR20.
Data source: The phase IIIb study randomized 229 patients to apremilast or placebo.
Disclosures: Celgene sponsored the trial. Dr. Nash has received research support from the company.
In Sweden, very few osteoporotic fractures prompt treatment within 12 months
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Only 6.6% of patients who were naive to osteoporotic therapy and experienced a break received a prescription.
Data source: The national registry study, comprising about 290,000 patients.
Disclosures: UCB Pharma sponsored the study with an unrestricted grant. Dr. Spångeus has received research funding from Amgen and Eli Lilly.
