Diana Mahoney

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”

BOSTON – The recombinant hepatitis B vaccine confers as much protection when given alone as it does when given together with hepatitis B immunoglobulin to newborns of chronically infected mothers, but neither regimen is optimally effective, a study has shown.

The randomized controlled trial assessed the hepatitis B virus (HBV) status of 222 infants born to mothers who tested positive for hepatitis B surface antigen (HBsAg). The rate of protection observed in infants who received only the vaccine was statistically similar to that of infants who received the vaccine plus hepatitis B immune globulin (HBIG).

A total of 39% of the vaccine-only group and 41% of the combination group remained infection free at a minimum of 18 weeks after birth, Dr. Shiv K. Sarin reported, noting that nearly half of the babies in both groups developed occult HBV infections.

The current standard of care for preventing HBV infection in babies born to mothers who are HBsAg positive is the recombinant hepatitis B virus vaccine plus HBIG, however previous studies have suggested the possibility that the vaccine alone may be as effective as the combination therapy, said Dr. Sarin of the Institute of Liver and Biliary Sciences in New Delhi.

To test this hypothesis, Dr. Sarin, along with lead investigator Dr. Chandana Pande, a research associate at G.B. Pant Hospital in New Delhi, and colleagues randomized the newborns of 222 women who screened positive for HBsAg during their prenatal care to receive the 0.5-mL recombinant HBV vaccine at birth, 6 weeks, 10 weeks, and 14 weeks, either alone (116 infants) or with 0.5 mL intramuscular HBIG (106 infants).

All of the babies were assessed at a minimum of 18 weeks for HBsAg, HBV-DNA, and antibodies to HBsAg (anti-HBs). The study's primary end point was freedom from overt or occult HBV infection with adequate immune response, defined as anti-HBs titers of at least 10 IU/mL, Dr. Sarin said in a poster presentation.

At 18 weeks after birth, 43 babies in the combination group and 45 in the vaccine-only group remained free of overt or occult HBV infection with adequate immune response, an insignificant difference. Of the babies not meeting the primary end point, 9 had overt HBV infection, including 2 in the combination group and 7 in the vaccine-only group, and 106 developed occult HBV infection, including 52 in the combination group and 54 in the vaccine-only group. Neither of these differences attained statistical significance. The large number of babies in both groups who developed occult HBV infection “may be due to intrauterine transmission of the infection,” Dr. Sarin suggested.

Dr. Sarin and Dr. Pande said they had no relevant financial disclosures.

BOSTON – The recombinant hepatitis B vaccine confers as much protection when given alone as it does when given together with hepatitis B immunoglobulin to newborns of chronically infected mothers, but neither regimen is optimally effective, a study has shown.

The randomized controlled trial assessed the hepatitis B virus (HBV) status of 222 infants born to mothers who tested positive for hepatitis B surface antigen (HBsAg). The rate of protection observed in infants who received only the vaccine was statistically similar to that of infants who received the vaccine plus hepatitis B immune globulin (HBIG).

A total of 39% of the vaccine-only group and 41% of the combination group remained infection free at a minimum of 18 weeks after birth, Dr. Shiv K. Sarin reported, noting that nearly half of the babies in both groups developed occult HBV infections.

The current standard of care for preventing HBV infection in babies born to mothers who are HBsAg positive is the recombinant hepatitis B virus vaccine plus HBIG, however previous studies have suggested the possibility that the vaccine alone may be as effective as the combination therapy, said Dr. Sarin of the Institute of Liver and Biliary Sciences in New Delhi.

To test this hypothesis, Dr. Sarin, along with lead investigator Dr. Chandana Pande, a research associate at G.B. Pant Hospital in New Delhi, and colleagues randomized the newborns of 222 women who screened positive for HBsAg during their prenatal care to receive the 0.5-mL recombinant HBV vaccine at birth, 6 weeks, 10 weeks, and 14 weeks, either alone (116 infants) or with 0.5 mL intramuscular HBIG (106 infants).

All of the babies were assessed at a minimum of 18 weeks for HBsAg, HBV-DNA, and antibodies to HBsAg (anti-HBs). The study's primary end point was freedom from overt or occult HBV infection with adequate immune response, defined as anti-HBs titers of at least 10 IU/mL, Dr. Sarin said in a poster presentation.

At 18 weeks after birth, 43 babies in the combination group and 45 in the vaccine-only group remained free of overt or occult HBV infection with adequate immune response, an insignificant difference. Of the babies not meeting the primary end point, 9 had overt HBV infection, including 2 in the combination group and 7 in the vaccine-only group, and 106 developed occult HBV infection, including 52 in the combination group and 54 in the vaccine-only group. Neither of these differences attained statistical significance. The large number of babies in both groups who developed occult HBV infection “may be due to intrauterine transmission of the infection,” Dr. Sarin suggested.

Dr. Sarin and Dr. Pande said they had no relevant financial disclosures.

BOSTON – The recombinant hepatitis B vaccine confers as much protection when given alone as it does when given together with hepatitis B immunoglobulin to newborns of chronically infected mothers, but neither regimen is optimally effective, a study has shown.

The randomized controlled trial assessed the hepatitis B virus (HBV) status of 222 infants born to mothers who tested positive for hepatitis B surface antigen (HBsAg). The rate of protection observed in infants who received only the vaccine was statistically similar to that of infants who received the vaccine plus hepatitis B immune globulin (HBIG).

A total of 39% of the vaccine-only group and 41% of the combination group remained infection free at a minimum of 18 weeks after birth, Dr. Shiv K. Sarin reported, noting that nearly half of the babies in both groups developed occult HBV infections.

The current standard of care for preventing HBV infection in babies born to mothers who are HBsAg positive is the recombinant hepatitis B virus vaccine plus HBIG, however previous studies have suggested the possibility that the vaccine alone may be as effective as the combination therapy, said Dr. Sarin of the Institute of Liver and Biliary Sciences in New Delhi.

To test this hypothesis, Dr. Sarin, along with lead investigator Dr. Chandana Pande, a research associate at G.B. Pant Hospital in New Delhi, and colleagues randomized the newborns of 222 women who screened positive for HBsAg during their prenatal care to receive the 0.5-mL recombinant HBV vaccine at birth, 6 weeks, 10 weeks, and 14 weeks, either alone (116 infants) or with 0.5 mL intramuscular HBIG (106 infants).

All of the babies were assessed at a minimum of 18 weeks for HBsAg, HBV-DNA, and antibodies to HBsAg (anti-HBs). The study's primary end point was freedom from overt or occult HBV infection with adequate immune response, defined as anti-HBs titers of at least 10 IU/mL, Dr. Sarin said in a poster presentation.

At 18 weeks after birth, 43 babies in the combination group and 45 in the vaccine-only group remained free of overt or occult HBV infection with adequate immune response, an insignificant difference. Of the babies not meeting the primary end point, 9 had overt HBV infection, including 2 in the combination group and 7 in the vaccine-only group, and 106 developed occult HBV infection, including 52 in the combination group and 54 in the vaccine-only group. Neither of these differences attained statistical significance. The large number of babies in both groups who developed occult HBV infection “may be due to intrauterine transmission of the infection,” Dr. Sarin suggested.

Dr. Sarin and Dr. Pande said they had no relevant financial disclosures.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, "disease activity will most likely not result in improvement," Dr. Nathan Vastesaeger reported at the annual meeting of the Canadian Rheumatology Association. As such, "the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy," he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF treatment, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or corticosteroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4, Dr. Vastesaeger reported.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, according to Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), "the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission," Dr. Vastesaeger reported. "This suggests a good prediction model according to the academic point system."

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, "only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24," said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his colleagues online March 14 in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

On the basis of the model, the investigators determined that patients younger than 40 years and those without enthesitis, in particular, demonstrated the highest likelihood of responding to TNF inhibition, and that these variables, along with CRP, functionality, and HLA-B27 status, are useful in the assessment of probable treatment response. The model, as an adjunct to expert opinion, "may help clinicians choose more appropriate therapies for patients in daily practice and may also help improve patient selection and protocol design for clinical studies," Dr. Vastesaeger concluded.

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.

Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.

At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:

Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.

The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).

"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.

Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.

Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.

The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).

"Unfortunately, neither study was associated with improvement in overall survival," he said.

PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).

In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.

Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.

The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.

NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."

Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.

HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.

Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.

At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:

Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.

The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).

"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.

Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.

Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.

The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).

"Unfortunately, neither study was associated with improvement in overall survival," he said.

PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).

In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.

Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.

The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.

NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."

Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.

HOLLYWOOD, FLA. – New data have led to upgrades of two rituximab regimens and radioimmunotherapy for follicular lymphoma in the National Comprehensive Cancer Network’s clinical practice guidelines for non-Hodgkin’s lymphoma.

Other changes include a section that addresses the utility of positron emission tomography in the assessment of follicular lymphoma and the addition of recommendations for the evaluation and management of posttransplant lymphoproliferative disorder (PTLD), according to Dr. Andrew D. Zelenetz of Memorial Sloan-Kettering Cancer Center in New York.

At the National Comprehensive Cancer Network’s annual conference on clinical practice guidelines, he reported updates in the following areas on behalf of the NCCN’s 30-member panel on non-Hodgkin’s lymphoma:

Rituximab plus bendamustine. The combination of rituximab (Rituxan) plus bendamustine (Treanda) has been upgraded from a category 2A to a category 1 recommendation for first-line treatment of follicular lymphoma, a common form of NHL, Dr. Zelenetz announced.

The most widely used first-line regimen for follicular lymphoma has been R-CHOP (a combination of rituximab, cyclophosphamide, doxorubicin HCl, vincristine sulfate, and prednisone). In a study presented in 2009 at the American Society of Hematology (ASH) annual meeting comparing the efficacy of the R-CHOP protocol with that of the rituximab-bendamustine (RB) combination, the complete remission rate among patients randomized to RB treatment was 73% vs. 39.6% in the R-CHOP arm, Dr. Zelenetz said (Blood [ASH Annual Meeting Abstracts] 2009 Nov.;114:405).

"The median progression-free survival was also higher [in the RB group], at 54.9 months compared with 34.8 months [in the R-CHOP arm]," a finding that he described as unexpected. "This study was designed as an equivalency study, and it certainly surprised many of us that rituximab-bendamustine was significantly better in terms of progression-free survival," he said.

Although there was no difference in overall survival between the two groups, he noted, the RB protocol was better tolerated with less hematologic toxicity and no alopecia.

Rituximab maintenance and radioimmunotherapy. The panel also upgraded rituximab maintenance and chemotherapy followed by radioimmunotherapy from a category 2B to a category 1 recommendation for the treatment of follicular lymphoma after the first remission. The guideline change regarding postremission management was sparked by the results of two recent studies, Dr. Zelenetz said.

The first demonstrated a significant reduction in the risk of recurrence among patients who received rituximab maintenance after responding to induction with rituximab plus chemotherapy (Lancet 2011;377:42-51). The other, presented at the 2010 ASH meeting, showed that postremission radioimmunotherapy following chemotherapy significantly improved the complete response and progression-free survival rates relative to the experience in patients who received no additional treatment following remission (Blood [ASH Annual Meeting Abstracts] 2010 Nov.;116:594).

"Unfortunately, neither study was associated with improvement in overall survival," he said.

PET imaging. In the assessment of follicular lymphoma, "studies have shown that PET imaging can be used to distinguish between indolent and aggressive lymphoma and can help guide the site for optimal biopsy, "especially in patients in whom there is a concern about transformation from indolent to aggressive disease," Dr. Zelenetz said. While it cannot replace biopsy, "[PET imaging] can help identify the best vs. the most convenient lymph node to biopsy," he said(J. Clin. Oncol. 2005;23:4643-51; Ann. Oncol. 2009; 20:508-12).

In addition, PET–computed tomography (PET-CT) has a role in the assessment of treatment response because "the predictive power of posttreatment PET-CT is stronger than other prognostic factors," Dr. Zelenetz explained.

Posttransplant lymphoproliferative disorder. PTLD "has emerged as a significant complication of solid organ and allogeneic bone marrow transplantation," according to Dr. Zelenetz.

The revised guidelines recommend outlining the procedure for establishing a diagnosis based on histology and immunophenotype, and categorizes relevant tests as essential or useful under certain circumstances. Among information deemed "essential," he said, is the determination of patients’ Epstein Barr virus (EBV) status, as well as their histopathology (polymorphic or monomorphic cells) and immunophenotype.

NCCN recommendations include reducing immunosuppression for patients with early lesions, which are usually associated with Epstein-Barr virus, and for those with polymorphic systemic and monomorphic disease. Treatment may include antiviral prophylaxis with gancyclovir (Cytovene), rituximab, or chemoimmunotherapy, depending on PTLD subtype, said Dr. Zelenetz, noting that "stem cell transplantation is usually reserved for relapse or refractory situations, as we would manage other aggressive lymphomas."

Dr. Zelenetz disclosed receiving grant and research support from companies including Amgen Inc., Celgene Corp., Cell Therapeutics Inc., Cephalon Inc., Genentech Inc., GlaxoSmithKline, and Sanofi-Aventis US.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto. For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported. Progression at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, rheumatoid factor (RF) status, and smoking history. Of these, "baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period," Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, said Ms. Chen. "Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline," she said.

The findings provide insight into the patterns and characteristics of radiographic damage in early rheumatoid arthritis, "and they may also contribute to clinical decision making," said Ms. Chen. The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Ms. Chen had no financial conflicts of interest to disclose.