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SNOWMASS, COLO. – Most rheumatologists view their patients’ vaccination status as a matter within the sphere of primary care medicine, but payers and health policy makers see things otherwise.
"You and I will soon be judged as to whether we’re good rheumatologists on the basis of whether our patients have gotten vaccinated, with almost complete certainty in my mind. This as a quality measure – ‘Are your patients getting vaccinated?’ – is undergoing measure-specification testing now by the American College of Rheumatology," Dr. Jeffrey R. Curtis said at the Winter Rheumatology Symposium sponsored by the ACR.
Flu, pneumococcal, HPV vaccines underused
Vaccination rates in patients with rheumatic diseases are unacceptably low, as highlighted in a study by Dr. Curtis and coinvestigators. They looked retrospectively at vaccination rates over a 5-year period in 141,140 rheumatoid arthritis (RA) patients, 6,300 others with psoriatic arthritis, and 770,520 osteoarthritis patients. Only 19%-22% of patients in the three groups received the influenza vaccine in all 5 years, and 29%-33% were vaccinated against pneumococcus.
Patients with RA or systemic lupus erythematosus (SLE) have been shown to be at 1.5-fold increased risk of high-grade cervical dysplasia, compared with the general population, yet less than 14% of females and less than 1% of males with autoimmune diseases have received the three-dose recombinant human papillomavirus (HPV) vaccine, as reported by Dr. Seoyoung C. Kim of Brigham and Women’s Hospital, Boston, and coworkers at the ACR 2013 annual meeting.
"My point is that we keep seeing this recurring theme: Our patients are at higher risk for infections and cervical cancer, we have vaccines that work to prevent those things, but we’re not using them and in most cases neither is primary care," said Dr. Curtis, director of the arthritis clinical intervention program and associate director of the Center for Education and Research on Therapeutics of Musculoskeletal Disorders at the University of Alabama, Birmingham.
"Regardless of whether you say this is a primary care thing and work with primary care to make sure it gets done, or you help enfranchise patients so they take control over this, or you’re going to do it your own self, you and I are going to be judged on this. It will be part of the new quality measures. This is happening," he emphasized.
One strategy Dr. Curtis said has been shown to be "reasonably effective" in several studies is to delegate responsibility for vaccinations to a mid-level practitioner, not on a patient-by-patient basis, but for the whole rheumatology practice.
Most studies indicate that long-term efficacy of vaccines is generally adequate in patients on methotrexate and/or biologics, albeit not as good as in the general population. The exception is rituximab (Rituxan): Patients on this drug have a greatly diminished humoral response to the PPSV-23 pneumococcal vaccine (Pneumovax) as well as to trivalent influenza vaccine. However, Dutch investigators showed that while the humoral response was seriously reduced in RA patients who got the flu vaccine 4-8 weeks after receiving rituximab, the immune response was modestly better when patients got the vaccine 6-10 months post rituximab (Arthritis Rheum. 2010;62:75-81).
"It matters when you got rituximab. If a patient got it a month or two ago, I wouldn’t bother vaccinating against influenza. Patients will have no response. But if it has been 6 or more months, it probably is worth doing," Dr. Curtis said.
Herpes zoster vaccination
RA patients are at 1.5- to 2-fold increased risk for herpes zoster, compared with the age-matched general population. The risk in lupus patients is even greater. Yet very few patients with these diseases get the live-virus herpes zoster vaccine.
The jury is still out as to whether anti–tumor necrosis factor therapies further raise that risk; the evidence is mixed. However, a particularly large study conducted by Dr. Curtis and coworkers in 24,000 older RA patients who were new users of anti-TNF biologics and nearly 12,000 who were new users of methotrexate and other nonbiologic DMARDs found that the rate of herpes zoster in the new users was 12.6 cases per 1,000 person-years, no higher than in those starting on nonbiologic DMARDs (JAMA 2013;309:887-95).
In contrast, a consistent finding in multiple studies is that the risk of herpes zoster is nearly twofold greater in RA patients receiving prednisone at greater than 7.5-10 mg/day. For example, the JAMA study by Dr. Curtis and coinvestigators found that baseline use of prednisone at more than 10 mg/day was independently associated with a 1.87-fold increased risk of zoster.
Tofacitinib (Xeljanz) clearly confers an increased risk of herpes zoster. At last fall’s annual ACR meeting, Dr. Curtis presented highlights of the worldwide clinical trial experience with tofacitinib in RA, totaling five phase III and six phase II randomized trials as well as two long-term extension studies. Tofacitinib was associated with a herpes zoster rate of 40-50 cases per 1,000 person-years, which is more than threefold higher than the rate with any anti-TNF agent.
"I think from a clinical perspective this definitely needs to be on our radar screen. Hopefully it makes the case that vaccination with the live-virus zoster vaccine, Zostavax, is compelling. I suspect that it’s not tofacitinib in particular, because early data for some of the other janus kinase inhibitors has suggested this problem is a class effect," Dr. Curtis said.
In vaccinating patients with RA and other rheumatic diseases, the recommended approach is whenever possible to give the vaccines before starting methotrexate or a biologic agent. That’s going to result in the greatest possible protection. The humoral response won’t be as robust if vaccines are given to patients already on treatment, but it’s still probably worth doing, except if they’ve recently received rituximab, he continued.
Vaccination guidelines not necessarily correct
Dr. Curtis cautioned that the major guidelines regarding vaccination of adults with rheumatic diseases should not automatically be taken as truth. For example, the ACR recommends against giving the live-virus herpes zoster vaccine to patients who are taking a biologic agent (Arthritis Care Res. 2012;64:625-39). But the European League Against Rheumatism (EULAR) guidelines state that the vaccine "may be considered" in such patients (Ann. Rheum. Dis. 2011;70:414-22).
Consistent with the EULAR stance, a study conducted by Dr. Curtis and coworkers in more than 463,000 elderly patients with RA or one of four other autoimmune diseases found that no safety issues arose in patients who were given the herpes zoster vaccine while on a TNF antagonist, a non-TNF biologic, or a nonbiologic DMARD. Moreover, the vaccine’s protective effect in RA patients on an anti-TNF biologic was similar to that seen in individuals without RA, with a 39% relative risk reduction, compared with unvaccinated individuals (JAMA 2012;308:43-9).
Here’s another point of contention regarding major practice guidelines: Recommendations from the Centers for Disease Control and Prevention state that glucocorticoid therapy is not a contraindication to administering live-virus vaccine to immunocompromised patients provided they are on low- to moderate-dose prednisone, which the CDC defines as less than 20 mg/day of prednisone for less than 14 days. Dr. Curtis disagrees.
"I consider 15 mg of prednisone more immunosuppressive than the biologics that we give," he said.
Dr. Curtis reported receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, and 10 pharmaceutical companies.
SNOWMASS, COLO. – Most rheumatologists view their patients’ vaccination status as a matter within the sphere of primary care medicine, but payers and health policy makers see things otherwise.
"You and I will soon be judged as to whether we’re good rheumatologists on the basis of whether our patients have gotten vaccinated, with almost complete certainty in my mind. This as a quality measure – ‘Are your patients getting vaccinated?’ – is undergoing measure-specification testing now by the American College of Rheumatology," Dr. Jeffrey R. Curtis said at the Winter Rheumatology Symposium sponsored by the ACR.
Flu, pneumococcal, HPV vaccines underused
Vaccination rates in patients with rheumatic diseases are unacceptably low, as highlighted in a study by Dr. Curtis and coinvestigators. They looked retrospectively at vaccination rates over a 5-year period in 141,140 rheumatoid arthritis (RA) patients, 6,300 others with psoriatic arthritis, and 770,520 osteoarthritis patients. Only 19%-22% of patients in the three groups received the influenza vaccine in all 5 years, and 29%-33% were vaccinated against pneumococcus.
Patients with RA or systemic lupus erythematosus (SLE) have been shown to be at 1.5-fold increased risk of high-grade cervical dysplasia, compared with the general population, yet less than 14% of females and less than 1% of males with autoimmune diseases have received the three-dose recombinant human papillomavirus (HPV) vaccine, as reported by Dr. Seoyoung C. Kim of Brigham and Women’s Hospital, Boston, and coworkers at the ACR 2013 annual meeting.
"My point is that we keep seeing this recurring theme: Our patients are at higher risk for infections and cervical cancer, we have vaccines that work to prevent those things, but we’re not using them and in most cases neither is primary care," said Dr. Curtis, director of the arthritis clinical intervention program and associate director of the Center for Education and Research on Therapeutics of Musculoskeletal Disorders at the University of Alabama, Birmingham.
"Regardless of whether you say this is a primary care thing and work with primary care to make sure it gets done, or you help enfranchise patients so they take control over this, or you’re going to do it your own self, you and I are going to be judged on this. It will be part of the new quality measures. This is happening," he emphasized.
One strategy Dr. Curtis said has been shown to be "reasonably effective" in several studies is to delegate responsibility for vaccinations to a mid-level practitioner, not on a patient-by-patient basis, but for the whole rheumatology practice.
Most studies indicate that long-term efficacy of vaccines is generally adequate in patients on methotrexate and/or biologics, albeit not as good as in the general population. The exception is rituximab (Rituxan): Patients on this drug have a greatly diminished humoral response to the PPSV-23 pneumococcal vaccine (Pneumovax) as well as to trivalent influenza vaccine. However, Dutch investigators showed that while the humoral response was seriously reduced in RA patients who got the flu vaccine 4-8 weeks after receiving rituximab, the immune response was modestly better when patients got the vaccine 6-10 months post rituximab (Arthritis Rheum. 2010;62:75-81).
"It matters when you got rituximab. If a patient got it a month or two ago, I wouldn’t bother vaccinating against influenza. Patients will have no response. But if it has been 6 or more months, it probably is worth doing," Dr. Curtis said.
Herpes zoster vaccination
RA patients are at 1.5- to 2-fold increased risk for herpes zoster, compared with the age-matched general population. The risk in lupus patients is even greater. Yet very few patients with these diseases get the live-virus herpes zoster vaccine.
The jury is still out as to whether anti–tumor necrosis factor therapies further raise that risk; the evidence is mixed. However, a particularly large study conducted by Dr. Curtis and coworkers in 24,000 older RA patients who were new users of anti-TNF biologics and nearly 12,000 who were new users of methotrexate and other nonbiologic DMARDs found that the rate of herpes zoster in the new users was 12.6 cases per 1,000 person-years, no higher than in those starting on nonbiologic DMARDs (JAMA 2013;309:887-95).
In contrast, a consistent finding in multiple studies is that the risk of herpes zoster is nearly twofold greater in RA patients receiving prednisone at greater than 7.5-10 mg/day. For example, the JAMA study by Dr. Curtis and coinvestigators found that baseline use of prednisone at more than 10 mg/day was independently associated with a 1.87-fold increased risk of zoster.
Tofacitinib (Xeljanz) clearly confers an increased risk of herpes zoster. At last fall’s annual ACR meeting, Dr. Curtis presented highlights of the worldwide clinical trial experience with tofacitinib in RA, totaling five phase III and six phase II randomized trials as well as two long-term extension studies. Tofacitinib was associated with a herpes zoster rate of 40-50 cases per 1,000 person-years, which is more than threefold higher than the rate with any anti-TNF agent.
"I think from a clinical perspective this definitely needs to be on our radar screen. Hopefully it makes the case that vaccination with the live-virus zoster vaccine, Zostavax, is compelling. I suspect that it’s not tofacitinib in particular, because early data for some of the other janus kinase inhibitors has suggested this problem is a class effect," Dr. Curtis said.
In vaccinating patients with RA and other rheumatic diseases, the recommended approach is whenever possible to give the vaccines before starting methotrexate or a biologic agent. That’s going to result in the greatest possible protection. The humoral response won’t be as robust if vaccines are given to patients already on treatment, but it’s still probably worth doing, except if they’ve recently received rituximab, he continued.
Vaccination guidelines not necessarily correct
Dr. Curtis cautioned that the major guidelines regarding vaccination of adults with rheumatic diseases should not automatically be taken as truth. For example, the ACR recommends against giving the live-virus herpes zoster vaccine to patients who are taking a biologic agent (Arthritis Care Res. 2012;64:625-39). But the European League Against Rheumatism (EULAR) guidelines state that the vaccine "may be considered" in such patients (Ann. Rheum. Dis. 2011;70:414-22).
Consistent with the EULAR stance, a study conducted by Dr. Curtis and coworkers in more than 463,000 elderly patients with RA or one of four other autoimmune diseases found that no safety issues arose in patients who were given the herpes zoster vaccine while on a TNF antagonist, a non-TNF biologic, or a nonbiologic DMARD. Moreover, the vaccine’s protective effect in RA patients on an anti-TNF biologic was similar to that seen in individuals without RA, with a 39% relative risk reduction, compared with unvaccinated individuals (JAMA 2012;308:43-9).
Here’s another point of contention regarding major practice guidelines: Recommendations from the Centers for Disease Control and Prevention state that glucocorticoid therapy is not a contraindication to administering live-virus vaccine to immunocompromised patients provided they are on low- to moderate-dose prednisone, which the CDC defines as less than 20 mg/day of prednisone for less than 14 days. Dr. Curtis disagrees.
"I consider 15 mg of prednisone more immunosuppressive than the biologics that we give," he said.
Dr. Curtis reported receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, and 10 pharmaceutical companies.
SNOWMASS, COLO. – Most rheumatologists view their patients’ vaccination status as a matter within the sphere of primary care medicine, but payers and health policy makers see things otherwise.
"You and I will soon be judged as to whether we’re good rheumatologists on the basis of whether our patients have gotten vaccinated, with almost complete certainty in my mind. This as a quality measure – ‘Are your patients getting vaccinated?’ – is undergoing measure-specification testing now by the American College of Rheumatology," Dr. Jeffrey R. Curtis said at the Winter Rheumatology Symposium sponsored by the ACR.
Flu, pneumococcal, HPV vaccines underused
Vaccination rates in patients with rheumatic diseases are unacceptably low, as highlighted in a study by Dr. Curtis and coinvestigators. They looked retrospectively at vaccination rates over a 5-year period in 141,140 rheumatoid arthritis (RA) patients, 6,300 others with psoriatic arthritis, and 770,520 osteoarthritis patients. Only 19%-22% of patients in the three groups received the influenza vaccine in all 5 years, and 29%-33% were vaccinated against pneumococcus.
Patients with RA or systemic lupus erythematosus (SLE) have been shown to be at 1.5-fold increased risk of high-grade cervical dysplasia, compared with the general population, yet less than 14% of females and less than 1% of males with autoimmune diseases have received the three-dose recombinant human papillomavirus (HPV) vaccine, as reported by Dr. Seoyoung C. Kim of Brigham and Women’s Hospital, Boston, and coworkers at the ACR 2013 annual meeting.
"My point is that we keep seeing this recurring theme: Our patients are at higher risk for infections and cervical cancer, we have vaccines that work to prevent those things, but we’re not using them and in most cases neither is primary care," said Dr. Curtis, director of the arthritis clinical intervention program and associate director of the Center for Education and Research on Therapeutics of Musculoskeletal Disorders at the University of Alabama, Birmingham.
"Regardless of whether you say this is a primary care thing and work with primary care to make sure it gets done, or you help enfranchise patients so they take control over this, or you’re going to do it your own self, you and I are going to be judged on this. It will be part of the new quality measures. This is happening," he emphasized.
One strategy Dr. Curtis said has been shown to be "reasonably effective" in several studies is to delegate responsibility for vaccinations to a mid-level practitioner, not on a patient-by-patient basis, but for the whole rheumatology practice.
Most studies indicate that long-term efficacy of vaccines is generally adequate in patients on methotrexate and/or biologics, albeit not as good as in the general population. The exception is rituximab (Rituxan): Patients on this drug have a greatly diminished humoral response to the PPSV-23 pneumococcal vaccine (Pneumovax) as well as to trivalent influenza vaccine. However, Dutch investigators showed that while the humoral response was seriously reduced in RA patients who got the flu vaccine 4-8 weeks after receiving rituximab, the immune response was modestly better when patients got the vaccine 6-10 months post rituximab (Arthritis Rheum. 2010;62:75-81).
"It matters when you got rituximab. If a patient got it a month or two ago, I wouldn’t bother vaccinating against influenza. Patients will have no response. But if it has been 6 or more months, it probably is worth doing," Dr. Curtis said.
Herpes zoster vaccination
RA patients are at 1.5- to 2-fold increased risk for herpes zoster, compared with the age-matched general population. The risk in lupus patients is even greater. Yet very few patients with these diseases get the live-virus herpes zoster vaccine.
The jury is still out as to whether anti–tumor necrosis factor therapies further raise that risk; the evidence is mixed. However, a particularly large study conducted by Dr. Curtis and coworkers in 24,000 older RA patients who were new users of anti-TNF biologics and nearly 12,000 who were new users of methotrexate and other nonbiologic DMARDs found that the rate of herpes zoster in the new users was 12.6 cases per 1,000 person-years, no higher than in those starting on nonbiologic DMARDs (JAMA 2013;309:887-95).
In contrast, a consistent finding in multiple studies is that the risk of herpes zoster is nearly twofold greater in RA patients receiving prednisone at greater than 7.5-10 mg/day. For example, the JAMA study by Dr. Curtis and coinvestigators found that baseline use of prednisone at more than 10 mg/day was independently associated with a 1.87-fold increased risk of zoster.
Tofacitinib (Xeljanz) clearly confers an increased risk of herpes zoster. At last fall’s annual ACR meeting, Dr. Curtis presented highlights of the worldwide clinical trial experience with tofacitinib in RA, totaling five phase III and six phase II randomized trials as well as two long-term extension studies. Tofacitinib was associated with a herpes zoster rate of 40-50 cases per 1,000 person-years, which is more than threefold higher than the rate with any anti-TNF agent.
"I think from a clinical perspective this definitely needs to be on our radar screen. Hopefully it makes the case that vaccination with the live-virus zoster vaccine, Zostavax, is compelling. I suspect that it’s not tofacitinib in particular, because early data for some of the other janus kinase inhibitors has suggested this problem is a class effect," Dr. Curtis said.
In vaccinating patients with RA and other rheumatic diseases, the recommended approach is whenever possible to give the vaccines before starting methotrexate or a biologic agent. That’s going to result in the greatest possible protection. The humoral response won’t be as robust if vaccines are given to patients already on treatment, but it’s still probably worth doing, except if they’ve recently received rituximab, he continued.
Vaccination guidelines not necessarily correct
Dr. Curtis cautioned that the major guidelines regarding vaccination of adults with rheumatic diseases should not automatically be taken as truth. For example, the ACR recommends against giving the live-virus herpes zoster vaccine to patients who are taking a biologic agent (Arthritis Care Res. 2012;64:625-39). But the European League Against Rheumatism (EULAR) guidelines state that the vaccine "may be considered" in such patients (Ann. Rheum. Dis. 2011;70:414-22).
Consistent with the EULAR stance, a study conducted by Dr. Curtis and coworkers in more than 463,000 elderly patients with RA or one of four other autoimmune diseases found that no safety issues arose in patients who were given the herpes zoster vaccine while on a TNF antagonist, a non-TNF biologic, or a nonbiologic DMARD. Moreover, the vaccine’s protective effect in RA patients on an anti-TNF biologic was similar to that seen in individuals without RA, with a 39% relative risk reduction, compared with unvaccinated individuals (JAMA 2012;308:43-9).
Here’s another point of contention regarding major practice guidelines: Recommendations from the Centers for Disease Control and Prevention state that glucocorticoid therapy is not a contraindication to administering live-virus vaccine to immunocompromised patients provided they are on low- to moderate-dose prednisone, which the CDC defines as less than 20 mg/day of prednisone for less than 14 days. Dr. Curtis disagrees.
"I consider 15 mg of prednisone more immunosuppressive than the biologics that we give," he said.
Dr. Curtis reported receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, and 10 pharmaceutical companies.
EXPERT ANALYSIS FROM THE ACR WINTER RHEUMATOLOGY SYMPOSIUM
