No Elevated Risk of Invasive Cancers Seen in JIA

PHILADELPHIA — Children followed for an average of 14 years after diagnosis of juvenile idiopathic arthritis showed no increased risk of invasive cancers, according to Dr. Ann Clarke.

Studies have shown an increased risk of malignancy—particularly lymphoma and lung cancer—in adult rheumatoid arthritis patients. This is the first assessment of cancer risk in children, she said at the annual meeting of the American College of Rheumatology.

In this study, the investigators analyzed juvenile idiopathic arthritis (JIA) registries maintained at two pediatric rheumatology centers located in Saskatoon, Sask., and Winnipeg, Man., between 1974 and 2006. Clinic patients were linked to regional tumor registries to determine any cancer occurrence. The observed malignancy incidence was compared with the expected incidence, based on general population cancer data, said Dr. Clarke of McGill University, Montreal.

The sample included 1,168 children with JIA (67.3% girls), most of whom were diagnosed when they were about 9 years old. Children were followed from the time of diagnosis until their death, their development of cancer, or the completion of the study interval at the end of 2006, for a total of 16,396 patient-years.

On the basis of regional age- and sex-specific general population cancer rates, the researchers expected six invasive cancers to be identified during the average 14 years of follow-up. In actuality, no cancers were found.

The investigators noted that the potential effect of medications on possible cancer risk is still not precisely known. In this cohort, about one-quarter of the children had been exposed to disease-modifying antirheumatic drugs, most commonly methotrexate. In all, 19 children had taken anti–tumor necrosis factor medications.

The U.S. Food and Drug Administration required stronger black boxed warnings in prescribing information that use of anti–tumor necrosis factor agents seemed to be associated with an increased risk for cancer among children

Dr. Thomas J.A. Lehman said in an interview that Dr. Clark's study illustrates that the risk of cancer in children receiving anti-TNF agents for JIA is very low. However, the anti-TNF warning by the FDA applies to children who received an anti-TNF agent for any reason not only children with juvenile arthritis.

A significant proportion of the children with reported malignancies noted by the FDA had inflammatory bowel disease, not juvenile arthritis. At the same time the FDA was able to draw on a much larger population of patients than the present study, said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

“Our obligation as physicians is to make sure families understand that the benefits of anti-TNF agents are very great and the risk to the individual child of developing a malignancy is almost vanishingly small. This study had no cases in all the children seen. We don't have adequate data to guarantee that there might not be a small increase in the risk of malignancies, but we do have adequate data demonstrating the dramatic benefits of anti-TNF agents.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

Dr. Clark noted that one limitation of the study was its predominantly white (80.5%) and First Nations/Inuit (16.9%) enrollment. She reported no conflicts.

PHILADELPHIA — Children followed for an average of 14 years after diagnosis of juvenile idiopathic arthritis showed no increased risk of invasive cancers, according to Dr. Ann Clarke.

Studies have shown an increased risk of malignancy—particularly lymphoma and lung cancer—in adult rheumatoid arthritis patients. This is the first assessment of cancer risk in children, she said at the annual meeting of the American College of Rheumatology.

In this study, the investigators analyzed juvenile idiopathic arthritis (JIA) registries maintained at two pediatric rheumatology centers located in Saskatoon, Sask., and Winnipeg, Man., between 1974 and 2006. Clinic patients were linked to regional tumor registries to determine any cancer occurrence. The observed malignancy incidence was compared with the expected incidence, based on general population cancer data, said Dr. Clarke of McGill University, Montreal.

The sample included 1,168 children with JIA (67.3% girls), most of whom were diagnosed when they were about 9 years old. Children were followed from the time of diagnosis until their death, their development of cancer, or the completion of the study interval at the end of 2006, for a total of 16,396 patient-years.

On the basis of regional age- and sex-specific general population cancer rates, the researchers expected six invasive cancers to be identified during the average 14 years of follow-up. In actuality, no cancers were found.

The investigators noted that the potential effect of medications on possible cancer risk is still not precisely known. In this cohort, about one-quarter of the children had been exposed to disease-modifying antirheumatic drugs, most commonly methotrexate. In all, 19 children had taken anti–tumor necrosis factor medications.

The U.S. Food and Drug Administration required stronger black boxed warnings in prescribing information that use of anti–tumor necrosis factor agents seemed to be associated with an increased risk for cancer among children

Dr. Thomas J.A. Lehman said in an interview that Dr. Clark's study illustrates that the risk of cancer in children receiving anti-TNF agents for JIA is very low. However, the anti-TNF warning by the FDA applies to children who received an anti-TNF agent for any reason not only children with juvenile arthritis.

A significant proportion of the children with reported malignancies noted by the FDA had inflammatory bowel disease, not juvenile arthritis. At the same time the FDA was able to draw on a much larger population of patients than the present study, said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

“Our obligation as physicians is to make sure families understand that the benefits of anti-TNF agents are very great and the risk to the individual child of developing a malignancy is almost vanishingly small. This study had no cases in all the children seen. We don't have adequate data to guarantee that there might not be a small increase in the risk of malignancies, but we do have adequate data demonstrating the dramatic benefits of anti-TNF agents.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

Dr. Clark noted that one limitation of the study was its predominantly white (80.5%) and First Nations/Inuit (16.9%) enrollment. She reported no conflicts.

PHILADELPHIA — Children followed for an average of 14 years after diagnosis of juvenile idiopathic arthritis showed no increased risk of invasive cancers, according to Dr. Ann Clarke.

Studies have shown an increased risk of malignancy—particularly lymphoma and lung cancer—in adult rheumatoid arthritis patients. This is the first assessment of cancer risk in children, she said at the annual meeting of the American College of Rheumatology.

In this study, the investigators analyzed juvenile idiopathic arthritis (JIA) registries maintained at two pediatric rheumatology centers located in Saskatoon, Sask., and Winnipeg, Man., between 1974 and 2006. Clinic patients were linked to regional tumor registries to determine any cancer occurrence. The observed malignancy incidence was compared with the expected incidence, based on general population cancer data, said Dr. Clarke of McGill University, Montreal.

The sample included 1,168 children with JIA (67.3% girls), most of whom were diagnosed when they were about 9 years old. Children were followed from the time of diagnosis until their death, their development of cancer, or the completion of the study interval at the end of 2006, for a total of 16,396 patient-years.

On the basis of regional age- and sex-specific general population cancer rates, the researchers expected six invasive cancers to be identified during the average 14 years of follow-up. In actuality, no cancers were found.

The investigators noted that the potential effect of medications on possible cancer risk is still not precisely known. In this cohort, about one-quarter of the children had been exposed to disease-modifying antirheumatic drugs, most commonly methotrexate. In all, 19 children had taken anti–tumor necrosis factor medications.

The U.S. Food and Drug Administration required stronger black boxed warnings in prescribing information that use of anti–tumor necrosis factor agents seemed to be associated with an increased risk for cancer among children

Dr. Thomas J.A. Lehman said in an interview that Dr. Clark's study illustrates that the risk of cancer in children receiving anti-TNF agents for JIA is very low. However, the anti-TNF warning by the FDA applies to children who received an anti-TNF agent for any reason not only children with juvenile arthritis.

A significant proportion of the children with reported malignancies noted by the FDA had inflammatory bowel disease, not juvenile arthritis. At the same time the FDA was able to draw on a much larger population of patients than the present study, said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

“Our obligation as physicians is to make sure families understand that the benefits of anti-TNF agents are very great and the risk to the individual child of developing a malignancy is almost vanishingly small. This study had no cases in all the children seen. We don't have adequate data to guarantee that there might not be a small increase in the risk of malignancies, but we do have adequate data demonstrating the dramatic benefits of anti-TNF agents.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

Dr. Clark noted that one limitation of the study was its predominantly white (80.5%) and First Nations/Inuit (16.9%) enrollment. She reported no conflicts.