Adalimumab Maintenance Therapy Research Articles

S1058 Certolizumab Pegol Improves Health-Related Quality of Life in Crohn's Disease Patients for Whom Infliximab Treatment Was Not Successful: Results from the WELCOME Study

Introduction: Adalimumab (ADA) was efficacious in the induction and maintenance of remission and in improving quality of life (QOL) for patients (pts) with Crohn's disease (CD) in CHARM.1,2 The current analysis assessed the long-term effects of ADA on QOL for pts in ADHERE, an open-label extension of CHARM. Methods: In CHARM, pts were randomized to placebo, 40-mg ADA every other week (eow), or 40-mg ADA weekly. Pts with flare/nonresponse could receive open-label (OL) ADA at/after Week 12. At the end of CHARM (56 weeks), pts could enter ADHERE; pts on blinded therapy received ADA eow and those on OL ADA maintained their therapy. In CHARM and ADHERE, pts could change from eow to weekly dosages for flares/nonresponse. Pts were followed for 3 years (yrs) from CHARM baseline. Efficacy and QOL were assessed by using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS). Results: This analysis included 328 ADA-treated pts who entered ADHERE. At both 2 yrs and 3 yrs from CHARM baseline, >50% of ADAtreated pts achieved IBDQ≥170 (Table). Statistically significant improvements in mean total IBDQ and SF-36 PCS and MCS scores were also observed at both time points. Conclusions: Clinically important improvements in QOL achieved with ADA in the CHARM trial were sustained through 3 yrs of ADA maintenance therapy.

S1057 Improvements in Work Productivity and Quality of Life in Adalimumab-Treated Patients with Crohn's Disease: the Care Trial

Introduction: Adalimumab (ADA) was efficacious in the induction and maintenance of remission and in improving quality of life (QOL) for patients (pts) with Crohn's disease (CD) in CHARM.1,2 The current analysis assessed the long-term effects of ADA on QOL for pts in ADHERE, an open-label extension of CHARM. Methods: In CHARM, pts were randomized to placebo, 40-mg ADA every other week (eow), or 40-mg ADA weekly. Pts with flare/nonresponse could receive open-label (OL) ADA at/after Week 12. At the end of CHARM (56 weeks), pts could enter ADHERE; pts on blinded therapy received ADA eow and those on OL ADA maintained their therapy. In CHARM and ADHERE, pts could change from eow to weekly dosages for flares/nonresponse. Pts were followed for 3 years (yrs) from CHARM baseline. Efficacy and QOL were assessed by using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS). Results: This analysis included 328 ADA-treated pts who entered ADHERE. At both 2 yrs and 3 yrs from CHARM baseline, >50% of ADAtreated pts achieved IBDQ≥170 (Table). Statistically significant improvements in mean total IBDQ and SF-36 PCS and MCS scores were also observed at both time points. Conclusions: Clinically important improvements in QOL achieved with ADA in the CHARM trial were sustained through 3 yrs of ADA maintenance therapy.

S1056 Quality-of-Life Improvements in Patients with Crohn's Disease Treated for 3 Years with Adalimumab in An Open-Label Extension of CHARM

Introduction: Adalimumab (ADA) was efficacious in the induction and maintenance of remission and in improving quality of life (QOL) for patients (pts) with Crohn's disease (CD) in CHARM.1,2 The current analysis assessed the long-term effects of ADA on QOL for pts in ADHERE, an open-label extension of CHARM. Methods: In CHARM, pts were randomized to placebo, 40-mg ADA every other week (eow), or 40-mg ADA weekly. Pts with flare/nonresponse could receive open-label (OL) ADA at/after Week 12. At the end of CHARM (56 weeks), pts could enter ADHERE; pts on blinded therapy received ADA eow and those on OL ADA maintained their therapy. In CHARM and ADHERE, pts could change from eow to weekly dosages for flares/nonresponse. Pts were followed for 3 years (yrs) from CHARM baseline. Efficacy and QOL were assessed by using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS). Results: This analysis included 328 ADA-treated pts who entered ADHERE. At both 2 yrs and 3 yrs from CHARM baseline, >50% of ADAtreated pts achieved IBDQ≥170 (Table). Statistically significant improvements in mean total IBDQ and SF-36 PCS and MCS scores were also observed at both time points. Conclusions: Clinically important improvements in QOL achieved with ADA in the CHARM trial were sustained through 3 yrs of ADA maintenance therapy.

Adalimumab maintenance therapy improves quality of life in patients with Crohn's disease

Adalimumab maintenance therapy improves quality of life in patients with Crohn's disease

10 - Patterns and predictors of dosage increase in patients treated with adalimumab for Crohn's disease in the United States

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S7 the Poisson regression, for CD and UC. A spatial analysis, with Bayesian approach was then performed. Results: From January 1, 2000 to December 31, 2002, 14,213 new patients with CD (8,172 women) and 12,452 new patients with UC (5,984 women) were registered by the five health insurance funds, among the overall insured population of 58,157,661. There was a significant negative correlation between age and gender-adjusted CD incidence rates, and local UV dose (IRR = 1.42, 95%CI [1.27 1.58] for the first quintile, IRR = 1.12, 95%CI [1.00 1.26] for the second quintile, IRR = 0.90, 95%CI [0.78 1.04] for the third quintile, IRR = 0.85, 95%CI [0.74 0.98], for the fourth quintile (fifth quintile = reference). Local UV dose improved the Bayesian model of geographic distribution of CD and the effect of local UV dose was stronger than the effect of local spatial autocorrelation. Variations of smoothed relative risks (sRR) of CD in both sexes according to the sunlight exposure are displayed in the figure. Areas with a sRR significantly higher than 1 corresponded to departments with low sunlight exposure, whereas those with high sunlight exposure had sRR either lower than 1 or not significantly different from 1. Conclusion: These results suggest that low sunlight exposure is a risk factor for CD. This hypothesis should be investigated within case-control or cohort studies. 10 Patterns and predictors of dosage increase in patients treated with adalimumab for Crohn’s disease in the United States E.V. Loftus Jr.1 *, X. Pan2, P. Zurawski3, P. Mulani3, J. Chao3. 1Miles & Shirley Fiterman Center for Digestive Diseases, Mayo Clinic, Rochester, MN, USA, 2University of Iowa, Iowa City, IA, USA, 3Abbott Laboratories, Abbott Park, IL, USA Introduction: Adalimumab, a fully human anti-tumor necrosis factor monoclonal antibody, is an effective treatment for Crohn’s disease (CD). After induction therapy, adalimumab 40mg is usually used as every-other-week dosing for maintenance therapy. In a large clinical trial, 27% of patients increased their adalimumab dosage to weekly within 1 year [1]. Information regarding the dosage pattern of adalimumab in real-world clinical practice is of interest. Our objective was to determine the dosage pattern of adalimumab in patients with CD covered by specialty pharmacies in the United States and to identify predictors for dosage increase to a weekly regimen. Methods: Using data from a large specialty pharmacydispensing database in the United States from March 2007 to July 2008, we studied patients with CD (ICD-9: 555) whose first dose of adalimumab was on or after 1 March 2007. New users of adalimumab were included in the analysis. Adalimumab maintenance therapy was defined as 3 dispensing events of adalimumab within 1 year. A weekly dosage regimen of adalimumab was defined as 2 consecutive weekly doses after the first dispensing event. Descriptive weekly dosing rates were determined by calculating the ratio of patients with weekly dosing to the total sample of adalimumab-treated patients. To control for the impact of variable follow-up times, Kaplan Meier analysis was used to estimate the weekly dosing rate for a 12-month period. To identify possible predictors for weekly dosing, a Cox proportional hazards regression model was developed to examine the impact of age, sex, geographic region, and use of a 160/80-mg induction dose on the weekly dosing rate. Results: Of 1335 patients with CD who received adalimumab as maintenance therapy, 11.3% (n = 151) had weekly dosing at any time during the study period. The 12-month cumulative risk of weekly dosing was 15.5% (Kaplan Meier analysis). The Cox proportional hazards model demonstrated that geographic region and not starting on 160/80mg for induction therapy were significant predictors for weekly adalimumab use. Patients who received 160/80mg as induction therapy were approximately half as likely to receive weekly dosing as those who didn’t start with 160/80mg (Hazards ratio [HR] = 0.48, 95%CI: 0.33 0.69, non-160/80-mg user as reference group, p < 0.0001). The western and southern regions of the United States had significantly lower rates of weekly dosing than did the northeastern region (HR = 0.50, 95%CI: 0.27 0.90 and HR= 0.46, 95%CI: 0.31 0.69, respectively, with northeast as reference group; both p < 0.05). Conclusions: The rate of adalimumab weekly dosing in clinical practice is less than the rates observed in clinical trials. Patients who received 160/80-mg induction therapy were significantly less likely to receive weekly dosing, and geographic variation in weekly adalimumab dosing rates was observed.

9 - Geographic distribution of inflammatory bowel disease (IBD) in France is influenced by sunlight exposure

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S7 the Poisson regression, for CD and UC. A spatial analysis, with Bayesian approach was then performed. Results: From January 1, 2000 to December 31, 2002, 14,213 new patients with CD (8,172 women) and 12,452 new patients with UC (5,984 women) were registered by the five health insurance funds, among the overall insured population of 58,157,661. There was a significant negative correlation between age and gender-adjusted CD incidence rates, and local UV dose (IRR = 1.42, 95%CI [1.27 1.58] for the first quintile, IRR = 1.12, 95%CI [1.00 1.26] for the second quintile, IRR = 0.90, 95%CI [0.78 1.04] for the third quintile, IRR = 0.85, 95%CI [0.74 0.98], for the fourth quintile (fifth quintile = reference). Local UV dose improved the Bayesian model of geographic distribution of CD and the effect of local UV dose was stronger than the effect of local spatial autocorrelation. Variations of smoothed relative risks (sRR) of CD in both sexes according to the sunlight exposure are displayed in the figure. Areas with a sRR significantly higher than 1 corresponded to departments with low sunlight exposure, whereas those with high sunlight exposure had sRR either lower than 1 or not significantly different from 1. Conclusion: These results suggest that low sunlight exposure is a risk factor for CD. This hypothesis should be investigated within case-control or cohort studies. 10 Patterns and predictors of dosage increase in patients treated with adalimumab for Crohn’s disease in the United States E.V. Loftus Jr.1 *, X. Pan2, P. Zurawski3, P. Mulani3, J. Chao3. 1Miles & Shirley Fiterman Center for Digestive Diseases, Mayo Clinic, Rochester, MN, USA, 2University of Iowa, Iowa City, IA, USA, 3Abbott Laboratories, Abbott Park, IL, USA Introduction: Adalimumab, a fully human anti-tumor necrosis factor monoclonal antibody, is an effective treatment for Crohn’s disease (CD). After induction therapy, adalimumab 40mg is usually used as every-other-week dosing for maintenance therapy. In a large clinical trial, 27% of patients increased their adalimumab dosage to weekly within 1 year [1]. Information regarding the dosage pattern of adalimumab in real-world clinical practice is of interest. Our objective was to determine the dosage pattern of adalimumab in patients with CD covered by specialty pharmacies in the United States and to identify predictors for dosage increase to a weekly regimen. Methods: Using data from a large specialty pharmacydispensing database in the United States from March 2007 to July 2008, we studied patients with CD (ICD-9: 555) whose first dose of adalimumab was on or after 1 March 2007. New users of adalimumab were included in the analysis. Adalimumab maintenance therapy was defined as 3 dispensing events of adalimumab within 1 year. A weekly dosage regimen of adalimumab was defined as 2 consecutive weekly doses after the first dispensing event. Descriptive weekly dosing rates were determined by calculating the ratio of patients with weekly dosing to the total sample of adalimumab-treated patients. To control for the impact of variable follow-up times, Kaplan Meier analysis was used to estimate the weekly dosing rate for a 12-month period. To identify possible predictors for weekly dosing, a Cox proportional hazards regression model was developed to examine the impact of age, sex, geographic region, and use of a 160/80-mg induction dose on the weekly dosing rate. Results: Of 1335 patients with CD who received adalimumab as maintenance therapy, 11.3% (n = 151) had weekly dosing at any time during the study period. The 12-month cumulative risk of weekly dosing was 15.5% (Kaplan Meier analysis). The Cox proportional hazards model demonstrated that geographic region and not starting on 160/80mg for induction therapy were significant predictors for weekly adalimumab use. Patients who received 160/80mg as induction therapy were approximately half as likely to receive weekly dosing as those who didn’t start with 160/80mg (Hazards ratio [HR] = 0.48, 95%CI: 0.33 0.69, non-160/80-mg user as reference group, p < 0.0001). The western and southern regions of the United States had significantly lower rates of weekly dosing than did the northeastern region (HR = 0.50, 95%CI: 0.27 0.90 and HR= 0.46, 95%CI: 0.31 0.69, respectively, with northeast as reference group; both p < 0.05). Conclusions: The rate of adalimumab weekly dosing in clinical practice is less than the rates observed in clinical trials. Patients who received 160/80-mg induction therapy were significantly less likely to receive weekly dosing, and geographic variation in weekly adalimumab dosing rates was observed.

Adalimumab maintenance therapy for patients with Crohnʼs Disease is cost effective compared with nonbiologic maintenance therapy

Adalimumab maintenance therapy for patients with Crohnʼs Disease is cost effective compared with nonbiologic maintenance therapy

Adalimumab maintenance therapy for patients with Crohnʼs Disease is cost effective compared with nonbiologic maintenance therapy

Adalimumab maintenance therapy for patients with Crohnʼs Disease is cost effective compared with nonbiologic maintenance therapy

Effects of Adalimumab Maintenance Therapy on Health-Related Quality of Life of Patients With Crohn's Disease: Patient-Reported Outcomes of the CHARM Trial

We evaluated the effects of adalimumab maintenance therapy on health-related quality of life (HRQOL) in patients with moderate to severe Crohn's disease. In a Phase III, randomized, double-blind clinical trial (CHARM) of moderate to severe Crohn's disease patients, HRQOL outcomes were compared between the adalimumab maintenance treatment groups (every other week and weekly injection) and the adalimumab induction-only group. The Zung Self-Rating Depression Scale, functional assessment of chronic illness therapy (FACIT)-Fatigue, visual analog pain scales, Inflammatory Bowel Disease questionnaire (IBDQ), and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were analyzed for 499 randomized responders (a decrease of > or =70 points from baseline in the Crohn's Disease Activity Index [CDAI]) at baseline and weeks 4, 12, 26, and 56. CHARM patients' HRQOL was substantially impaired at baseline. Following a 4-week adalimumab induction therapy, patients experienced statistically significant improvements in all HRQOL measures (P < 0.0001). Compared with patients who were assigned to placebo after induction therapy, patients who continued adalimumab at 40 mg every other week maintenance therapy reported less depression (P < 0.01), fewer fatigue symptoms (P < 0.001), greater improvements in the IBDQ (P < 0.05), greater SF-36 physical component summary scores (P < 0.05), and less abdominal pain (P < 0.05) from weeks 12 to 56. They also had greater SF-36 mental component summary scores at week 56 (P < 0.05). Patients who continued adalimumab at 40-mg weekly maintenance therapy reported less depression and fewer fatigue symptoms at week 56, greater improvement in IBDQ, and less abdominal pain from weeks 12 to 56 (all P < 0.05 vs. placebo). Adalimumab maintenance therapy provided sustained improvements in HRQOL for patients with moderate to severe Crohn's disease through week 56.

Adalimumab Maintenance Therapy Is Associated with a Reduced Risk of Major Surgery

Purpose: The majority of patients with Crohn's disease (CD) will undergo surgery during their lifetimes. In 2006, CD-related hospitalizations involving surgery were twice as costly as non-surgical hospitalizations with estimated annual costs of $49,4051. Adalimumab (ADA) is approved in the U.S. for use in the treatment of moderate to severe CD in adults. CHARM was a 56-week, Phase III, randomized, placebo-controlled trial that assessed the ability of ADA to maintain clinical remission in patients (pts) with moderate to severe CD. Methods: We evaluated the effects of ADA maintenance therapy on major CD-related surgery in pts who participated in the CHARM trial. At Week 4 of the study, 778 pts were randomized to 40 mg ADA every other week (eow), 40 mg ADA weekly, or placebo, and studies through 56 weeks. All pts were followed from Week 4 (ie, after randomization) until the first occurrence of the following events: switch to open-label therapy with ADA, withdrawal from the study, or end of trial. The numbers of major CD-related surgeries for each treatment group, as assigned by 2 authors (BGF and KGL), were compared through Poisson regression analysis. Major CD-related surgeries, excluding drainage of abscess and placement of a seton, were those performed in hospital, recorded as serious adverse events in the trial, and deemed to be major by the investigators. Kaplan–Meier estimates of CD-related surgical hospitalization rates were compared using log-rank test. Results: The rate of CD-related surgeries was significantly reduced by 80–90% in patients receiving ADA eow or weekly therapies versus patients on placebo. These rates were 0.4%, 0.8%, 0.6%, and 3.8% in the ADA eow, weekly, combined ADA, and placebo arm respectively (all P≤ 0.01 vs placebo). Based on Kaplan–Meier analysis, the 1-year actuarial CD-related surgical hospitalization rates for the eow, weekly, combined ADA, and the placebo groups were 0.7%, 1.2%, 1.0%, and 4.8%, respectively (all P < 0.05 vs placebo, log-rank test). Conclusion: Patients who received adalimumab maintenance therapy had a significant decreased risk for CD-related surgery and surgical hospitalization. These findings demonstrate the importance of effective maintenance therapy for altering the natural course of disease and have significant cost implications for society and third-party payers.

Adalimumab Maintenance Therapy Is Cost Effective for Maintaining Remission in Patients with Crohnʼs Disease

Purpose: Adalimumab, a fully human monoclonal antibody targeting tumor necrosis factor, is approved for treatment of adults with moderate severe Crohn's disease (CD). CLASSIC I and CHARM are two Phase III studies of the effectiveness of adalimumab in inducing and maintaining remission, respectively, in patients with moderate to severe CD. Methods: The objective of this analysis was to evaluate the cost-effectiveness of adalimumab compared to nonbiologic therapies in the maintenance treatment of CD. A cost-utility model compared these strategies from the perspective of the UK National Health Service over 1-year and lifetime horizons. Patients were modeled in four disease states based on their Crohn's Disease Activity Index (CDAI) scores. CHARM data were directly used to estimate adalimumab arm efficacy. A regression model using CLASSIC I data was used to similarly predict the CDAI state of patients who received standard of care. Hospitalizations for both arms were modeled using the clinical trials data. Utilization of other medical resources was based on CDAI states. The cost of adalimumab was £357.50 per 40 mg vial, and the cost of standard care drugs was assumed to be zero. Costs of hospitalization and other medical resources were taken from Bassi et al., 2004. All costs were inflated to 2006 British Pounds (GBP) based on the annual UK health price index. Health utility inputs were sourced from Gregor et al., 1997. Univariate and probabilistic sensitivity analyses were conducted. Results: Compared with nonbiologic therapy, adalimumab appeared to be cost-effective in the treatment of patients with both severe CD and moderate to severe CD, with a 56-week incremental cost effectiveness ratio (ICER) of £16,064/quality-adjusted life-year (QALY) and £33,731/QALY, respectively. Sensitivity analyses demonstrated that the findings were robust. In the treatment of patients over their lifetimes, the ICERs were £5,479/QALY for patients with severe CD and £16,065/QALY for patients with moderate to severe CD. Sensitivity analyses demonstrated the robustness of the base case analysis. Conclusion: Adalimumab maintenance therapy for CD was cost-effective when compared to conventional nonbiological management. This research was funded by Abbott Laboratories, Abbott Park, IL.

Efficacy of Adalimumab for the Treatment of TNF-Antagonist-Naïve Patients with Crohnʼs Disease

Purpose: Adalimumab (ADA) is approved in the U.S. for use in the treatment of moderate to severe Crohn's disease (CD) in adults. The CHARM trial was a 56-week, Phase III, randomized controlled trial that assessed ADA in maintaining clinical remission in patients (pts) with moderate to severe CD. Methods: We sought to evaluate the impact of ADA maintenance therapy on clinical efficacy for TNF-antagonist-naïve pts in the CHARM trial. Pts received open-label induction therapy of 80 mg ADA at baseline (Week 0) and 40 mg at Week 2. At Week 4, pts were stratified by responder status and randomized to 40 mg ADA every other week (eow), 40 mg ADA weekly, or placebo. All TNF-antagonist-naïve pts were included in the analysis regardless of Week 4 response status. Efficacy outcomes included remission (CDAI < 150), CR-70 (a decrease of 70 points in CDAI from the baseline), and CR-100 (a decrease of 100 points in CDAI from the baseline), which were compared by chi-square analysis. ANCOVA was used to control for baseline score and Week-4 responder status, and was used to compare the differences in change of IBDQ score from baseline at Week 26 and Week 56 between the ADA and placebo groups. Nonresponder imputation was used when CDAI scores were missing or pts moved out of the double-blind treatment arm. Results: The percentage of pts in remission was significantly greater for the ADA 40-mg eow and 40-mg weekly groups vs. placebo at Weeks 26 and 56. At these same time points, clinical response rates were also significantly greater for the ADA groups vs. placebo (Table). ADA maintenance therapy also demonstrated a significant benefit in IBDQ total score compared with placebo at all points after the induction period (P < 0.05).Table: Clinical Remission and Response in TNF-Antagonist-Naïve Patients Receiving Adalimumab

Continuous vs. Induction Only/Reinitiated Adalimumab Maintenance Therapy Yields Optimal Results for Moderate to Severe Crohnʼs Disease: Subanalysis of CHARM

Table: CMT vs. IO/R at Wk 56Purpose: Fully human monoclonal antibody, adalimumab (ADA), with demonstrated efficacy and safety in CHARM, is approved for treating moderate to severe Crohn's disease (CD). In this subanalysis, we compared ADA efficacy of continuous maintenance therapy (CMT) vs. Induction Only/Reinitiation (IO/R) therapies. Methods: In CHARM, 854 pts received ADA, 80 mg/40 mg at Weeks (Wks) 0/2. At Wk 4, 778 pts were randomized to receive ADA 40 mg every other week (EOW; N = 260) or weekly (EW; N = 257), or placebo (PBO; N = 261) through Wk 56. At/after Wk 12, pts could switch to open-label (OL) ADA 40 mg EOW and increase to EW for flare/non-response. Pts on OL EW could not de-escalate to EOW. ADA efficacy (remission [CDAI < 150], total IBDQ, fistula closure, flare occurrence, and hospitalization risk) was compared with CMT vs. IO/R—pts who received IO therapy followed by PBO, or pts randomized to PBO and later reinitiated on OL ADA. The CMT group included pts on randomized ADA who either remained on blinded therapy or subsequently went to OL. A Cox proportional hazard model, after stepwise confounder selection, estimated the effect of ADA on hospitalization risk, controlling for Wk-4 responder status, stenosis/stricture history, and age. Results: Conclusion: CMT ADA therapy resulted in significantly greater remission rates, quality of life improvements, fewer flares, and reduction in all-cause and CD-related hospitalizations vs. IO/R therapy. The preponderance and consistency of these analyses collectively suggest CMT with ADA yields superior results for pts with moderate to severe CD when compared with IO/R dosing.

Adalimumab maintenance therapy for Crohn’s disease with intolerance or lost response to infliximab: an open‐label study

Adalimumab is effective in inducing remission in patients with active Crohn's disease who had secondary failure to infliximab therapy. To evaluate the efficacy and safety of adalimumab maintenance therapy in Crohn's disease patients who previously responded to infliximab and then lost response or became intolerant. Twenty-four patients with Crohn's disease were enrolled in a 52-week open-label trial. The patients received a loading dose of adalimumab 80-mg at week 0, and then 40 mg every other week starting at week 2. The primary efficacy measure was clinical remission defined as Crohn's Disease Activity Index score < 150 at week 52. Five patients lost response to adalimumab. None of the patients experienced intolerance to adalimumab. Clinical remission rates were higher at weeks 4 (16/24, 67%) and 52 (14/24, 58%) compared with baseline (8/24, 35%) (P=0.043 at week 52). This was accompanied by a decrease in mean C-reactive protein concentration from 31.8 mg/mL at baseline to 9.7 mg/mL at week 52, and 3/4 (75%) patients achieved steroid-free remission. No serious toxicities occurred in the study. Adalimumab is well tolerated and appears to be effective in maintaining clinical remission in patients with Crohn's disease and lost response or intolerance to infliximab.