Adalimumab Linked to Sizeable Rates of RA Remission

WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

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WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — Clinical remission—a therapeutic goal increasingly achievable in the era of biologic therapies—was reached by a substantial percentage of patients with long-standing active rheumatoid arthritis treated with adalimumab, Dr. Gerd M. Burmester reported at the annual meeting of the American College of Rheumatology.

Nearly one-third of patients who participated in the Research in Active RA (ReAct) trial, which took place at 448 sites in Europe and Australia, achieved clinical remission as assessed on several different criteria.

ReAct included 6,610 patients, 81% of whom were female, whose mean age was 54 years and whose mean disease duration was 11 years.

Among this cohort 73% were rheumatoid factor positive, 74% were receiving disease-modifying antirheumatic drugs, and 71% were receiving corticosteroids, according to Dr. Burmester.

The patients mean disease activity score (DAS) 28 at baseline was 6, and their mean Health Assessment Questionnaire Disability Index (HAQ DI) score at baseline was 1.64.

During the initial 12-week open-label phase of the trial, patients received subcutaneous adalimumab (Humira), 40 mg every other week, in addition to their current disease-modifying drugs.

The 6,235 patients who remained in the study at week 12 then could enter an extension phase.

At week 28, 4,119 remained in the study, as did 3,021 at week 36 and 1,251 at week 52.

Clinical remission assessed on the DAS 28 was achieved by 20% of patients at week 12, according to Dr. Burmester of Charité Hospital, Berlin, Germany.

Of the 1,251 patients who received 52 weeks of adalimumab therapy, 164 (13%) achieved a major clinical response, which is an ACR70 response for 6 continuous months or more, Dr. Burmester wrote in a poster session.

The study also found that greater percentages of patients with baseline low DAS 28 and HAQ DI scores achieved and maintained clinical remission than did patients who were more severely disabled at study entry.

Dr. Burmester disclosed that he has received research grants and consulting fees and is on the speakers' bureau for multiple pharmaceutical companies, including Abbott, the manufacturer of adalimumab.

Analysis of data from ReAct has also demonstrated that adalimumab can be beneficial in patients who have previously received one or two other tumor necrosis factor (TNF)-α blocking agents, according to Dr. Stefano Bombardieri of the University of Pisa (Italy).

Among the patients enrolled in ReAct, 188 had previously received etanercept, 591 had received infliximab, and 120 had been treated with both drugs but had discontinued because of intolerance or loss of response.

At week 12, 60% of patients who had received previous anti-TNF-α treatment achieved an ACR20 response, as did 70% of patients who had not received any prior anti-TNF-α therapy.

Treatment with adalimumab also led to clinically important improvements in physical function as measured on mean changes from baseline in HAQ scores, even among difficult-to-treat patients who had received two previous anti-TNF-α drugs, Dr. Bombardieri wrote in another poster presentation.

Among patients who had not previously received any of the drugs, the mean change in HAQ DI from baseline was −0.58, while those who had received both of the other drugs had a mean change of −0.31.

Serious adverse events were reported in 13% and 18% of patients without and with a history of anti-TNF-α treatment, respectively, Dr. Bombardieri reported in his poster.

The malignancy rate was 0.6% in patients without and 0.8% in patients with such a history.

Dr. Bombardieri disclosed that he has received consulting fees from Abbott.

Analysis of data from another trial, the Humira Efficacy Response Optimization (HERO) study, found that clinical improvements in patients began as early as 1 day after the initiation of therapy with adalimumab.

In HERO, 1,938 patients with active RA were randomized to receive a blinded dose of subcutaneous adalimumab (40 mg) or placebo.

At 2 weeks, all patients began open-label treatment with the active drug.

During the 2-week blinded phase of this trial, patients recorded their pain, functional disability, fatigue, stiffness, and global assessment of disease activity using electronic diaries.

As early as day 1, the e-diary assessments of symptom severity in the adalimumab group showed improvements of 5.7 points on the 100-point visual analog scale, compared with a 0.9-point improvement in the placebo group, a difference that was statistically significant, Dr. Frederick Wolfe wrote in a separate poster session.

Nearly half of the total patient improvements seen with adalimumab therapy occurred during the first 14 days of treatment, and once the placebo patients were switched to active treatment they showed similar improvements, according to Dr. Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan.

Dr. Wolfe disclosed that the National Data Bank for Rheumatic Diseases has received research support from several companies, including Abbott.

Of 1,251 patients receiving 52 weeks of adalimumab, 13% achieved a major clinical response. DR. BURMESTER

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