Rheumatoid Arthritis Patients Receiving Anti-TNF Therapy Can Be Effectively Immunized

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Rheumatoid Arthritis Patients Receiving Anti-TNF Therapy Can Be Effectively

Immunized

http://www.newswise.com/articles/view/524905/?sc=dwtn

Despite being immunosuppressed, patients with rheumatoid arthritis are able

to develop protective antibodies following pneumococcal and influenza

vaccinations when also treated with anti-TNF agents, thus reducing their

risk for developing the flu and the most common type of bacterial pneumonia,

according to research presented this week at the American College of

Rheumatology Annual Scientific Meeting in Washington, DC.

Flu shots are given annually to combat the influenza that plagues 5 to 20

percent of Americans each year. In many cases, these infections can lead to

severe complications, especially in the elderly and patients with chronic

illnesses, causing approximately 36,000 annual deaths among Americans.

Because patients with rheumatoid arthritis are immunosuppressed, there is

longstanding concern about the effectiveness of vaccinations for disease

prevention.

To examine the effectiveness of anti-bacterial pneumococcal vaccination and

anti-viral influenza vaccinations, 226 patients with active rheumatoid

arthritis participated in a double-blind study during the 2003-2004

influenza season. Each patient received either the biologic, adalimumab, or

a placebo over a 30-day period. Those taking the biologic drug were given 80

mg on day 1 followed by 40 mg on days 15 and 29. Vaccines for pneumococcus

(23-valent) and influenza virus (trivalent subvirion) were administrated

intramuscularly to all patients on day 8. Response to vaccination was

determined 4 weeks following vaccination (day 36).

Researchers found no significant difference between the adalimumab and

placebo groups among the 208 patients with analyzable data when comparing

the percentages of patients with protective antibody concentrations in

response to both vaccines. This indicates that adalimumab therapy did not

diminish the participants' abilities to develop the necessary protective

immune response. Preliminary studies of several other biologic agents in

rheumatoid arthritis suggest similar results, but this is the largest

placebo-controlled study conducted to date.

" As physicians, we believe all patients at risk of influenza or pneumococcal

pneumonia should receive vaccination regardless of whether or not they have

rheumatoid arthritis, " says Kaine, MD, Director, Sarasota Arthritis

Research Center, Sarasota, Florida, and an investigator in the study.

" However, the fact that we now have evidence to suggest that these vaccines

are effective in the rheumatoid arthritis patient population offers

physicians and their patients peace of mind. "

The American College of Rheumatology is the professional organization for

rheumatologists and health professionals who share a dedication to healing,

preventing disability and curing arthritis and related rheumatic and

musculoskeletal diseases. For more information on the ACR's annual meeting,

see http://www.rheumatology.org/annual.

Presentation Number: 1235

Abilities to Develop Protective Antibodies to Pneumococcal and Influenza

Vaccine are Maintained in Rheumatoid Arthritis (RA) Patients Treated with

Adalimumab (Humira)

J. Kaine1, A. Kivitz2, C. Birbara3, A. Y. Luo4. 1Sarasota Arthritis Center,

Sarasota, FL; 2Altoona Center for Clinical Research, Duncansville, PA;

3Clinical Pharmacology Study Group, Worcester, MA; 4Abbott, Parsippany, NJ

Purpose: Streptococcus pneumoniae and influenza virus are prominent

infectious agents that can cause morbidity and mortality in RA. Although

routine pneumococcal and influenza vaccinations are recommended, treatment

with steroids, immunosuppressants, and/or TNF antagonists may affect immune

response. This study evaluated the effects of adalimumab on antibody (Ab)

response to pneumococcal (pneum) and influenza (infz) vaccines in adult RA

pts.

Methods: Patients (pts) with active RA were enrolled during the 2003-04 US

infz season into this double-blind, placebo-controlled study. Pts randomized

to adalimumab received 80 mg on Day 1 followed by 40 mg on Days 15 and 29.

Standard 23-valent pneum and trivalent subviron infz virus vaccines were

administered intramuscularly to all pts on Day 8. Ab titers (9V, 14, 18C,

19F, and 23F for pneum; H1N1, H3N2, and Hong Kong for infz) were measured on

Day 8 (prevaccination) and Day 36. Protective Ab status for pneum vaccine

was defined as ?1.6 mg/mL in >=3 of 5 antigens and response to vaccination

was defined as >=2-fold increase from baseline (BL) in Ab titer in >=3 of 5

antigens. Protective Ab status for infz vaccine was defined as >=1:40 titer

in >=2 of 3 antigens, and response to vaccination was defined as >=4-fold

increase from BL in Ab titer in >=2 of 3 antigens.

Results: A total of 226 pts were randomized. The analysis comprised data

from 208 pts who had received at least the first 2 doses of blinded study

drug (on Days 1 and 15) and had both pre- and post-vaccine Ab analyses. No

significant difference between groups existed in either BL demographics or

Ab levels.

For pneum vaccine, the %s of pts with protective Ab status 4-weeks after

vaccination were comparable in both arms, as were the %s of pts in both

groups who developed Ab response. For infz vaccine, the %s of pts who had

protective Ab status 4-weeks after vaccination were also comparable in the 2

groups. The % of pts who developed infz Ab response was smaller in the

adalimumab arm, driven by the subgroup of pts that already had protective Ab

status at BL. Among pts without protective Ab status at baseline, the

response rates were similar in the 2 groups. The frequencies and types of

adverse events were similar to those observed in other adalimumab studies.

4 Weeks After Vaccination Placebo Adalimumab

Influenza: protective antibody status 103/109 (94.5%) 97/99 (98.0%)

Influenza: developed antibody response 69/109 (63.3%) 51/99 (51.5%)

Response in patients with protective influenza antibody status at baseline

35/63 (55.6%) 21/58 (36.2%)

Response in patients without protective influenza antibody status at

baseline 34/46 (73.9%) 30/41 (73.3%)

Pneumococcal: protective antibody Status 89/109 (81.7%) 85/99 (85.9%)

Pneumococcal: developed antibody response 44/109 (40.4%) 37/99 (37.4%)

Response in patients with protective pneumococcal antibody status at

baseline 17/62 (27.4%) 16/57 (28.1%)

Response in patients without protective pneumococcal antibody status at

baseline 27/47 (54.7%) 21//42 (50.0%)

Conclusion: Adalimumab does not diminish ability to develop protective

antibody from pneumococcal and influenza vaccines in RA pts. These findings

demonstrate that RA pts on adalimumab can be effectively and safely

immunized with these vaccines.

Disclosure Block: J. Kaine, Abbott, 5 Consulting fees.