CLINICAL STUDIES
Rheumatoid Arthritis
The efficacy and safety of HUMIRA were assessed in five randomized, double-blind studies in patients ≥ age 18 with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. Patients had at least 6 swollen and 9 tender joints. HUMIRA was administered subcutaneously in combination with methotrexate (MTX) (12.5 to 25 mg, Studies RA-I, RA-III and RA-V) or as monotherapy (Studies RA-II and RA-V) or with other disease-modifying anti-rheumatic drugs (DMARDs) (Study RA-IV).
Study RA-I evaluated 271 patients who had failed therapy with at least one but no more than four DMARDs and had inadequate response to MTX. Doses of 20, 40 or 80 mg of HUMIRA or placebo were given every other week for 24 weeks.
Study RA-II evaluated 544 patients who had failed therapy with at least one DMARD. Doses of placebo, 20 or 40 mg of HUMIRA were given as monotherapy every other week or weekly for 26 weeks.
Study RA-III evaluated 619 patients who had an inadequate response to MTX. Patients received placebo, 40 mg of HUMIRA every other week with placebo injections on alternate weeks, or 20 mg of HUMIRA weekly for up to 52 weeks. Study RA-III had an additional primary endpoint at 52 weeks of inhibition of disease progression (as detected by X-ray results). Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of HUMIRA was administered every other week for up to 5 years.
Study RA-IV assessed safety in 636 patients who were either DMARD-naive or were permitted to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days. Patients were randomized to 40 mg of HUMIRA or placebo every other week for 24 weeks.
Study RA-V evaluated 799 patients with moderately to severely active rheumatoid arthritis of less than 3 years duration who were ≥18 years old and MTX naïve. Patients were randomized to receive either MTX (optimized to 20 mg/week by week 8), HUMIRA 40 mg every other week or HUMIRA/MTX combination therapy for 104 weeks. Patients were evaluated for signs and symptoms, and for radiographic progression of joint damage. The median disease duration among patients enrolled in the study was 5 months. The median MTX dose achieved was 20 mg.
Clinical Response
The percent of HUMIRA treated patients achieving ACR 20, 50 and 70 responses in Studies RA-II and III are shown in Table 2.
Table 2: ACR Responses in Studies RA-II and RA-III (Percent of Patients) | Study RA-II Monotherapy (26 weeks) | Study RA-III Methotrexate Combination (24 and 52 weeks) |
* p<0.01, HUMIRA vs. placebo |
Response | Placebo | HUMIRA 40 mg | HUMIRA | Placebo/MTX | HUMIRA/MTX |
| | every other week | 40 mg weekly | | 40 mg every |
| | | | | other week |
| N=110 | N=113 | N=103 | N=200 | N=207 |
ACR20 | | | | | |
Month 6 | 19% | 46%* | 53%* | 30% | 63%* |
Month 12 | NA | NA | NA | 24% | 59%* |
ACR50 | | | | | |
Month 6 | 8% | 22%* | 35%* | 10% | 39%* |
Month 12 | NA | NA | NA | 10% | 42%* |
ACR70 | | | | | |
Month 6 | 2% | 12%* | 18%* | 3% | 21%* |
Month 12 | NA | NA | NA | 5% | 23%* |
The results of Study RA-I were similar to Study RA-III; patients receiving HUMIRA 40 mg every other week in Study RA-I also achieved ACR 20, 50 and 70 response rates of 65%, 52% and 24%, respectively, compared to placebo responses of 13%, 7% and 3% respectively, at 6 months (p<0.01).
The results of the components of the ACR response criteria for Studies RA-II and RA-III are shown in Table 3. ACR response rates and improvement in all components of ACR response were maintained to week 104. Over the 2 years in Study RA-III, 20% of HUMIRA patients receiving 40 mg every other week (every other week) achieved a major clinical response, defined as maintenance of an ACR 70 response over a 6-month period.
ACR responses were maintained in similar proportions of patients for up to 5 years with continuous HUMIRA treatment in the open-label portion of Study RA-III.
Table 3: Components of ACR Response in Studies RA-II and RA-III | Study RA-II | Study RA-III |
- a40 mg HUMIRA administered every other week
- bVisual analogue scale; 0 = best, 10 = worst
- cDisability Index of the Health Assessment Questionnaire; 0 = best, 3 = worst, measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity
- *p<0.001, HUMIRA vs. placebo, based on mean change from baseline
|
Parameter (median) | Placebo N=110 | HUMIRAa N=113 | Placebo/MTX N=200 | HUMIRAa/MTX N=207 |
| Baseline | Wk 26 | Baseline | Wk 26 | Baseline | Wk 24 | Baseline | Wk 24 |
Number of tender joints (0-68) | 35 | 26 | 31 | 16* | 26 | 15 | 24 | 8* |
Number of swollen joints (0-66) | 19 | 16 | 18 | 10* | 17 | 11 | 18 | 5* |
Physician global assessmentb | 7.0 | 6.1 | 6.6 | 3.7* | 6.3 | 3.5 | 6.5 | 2.0* |
Patient global assessmentb | 7.5 | 6.3 | 7.5 | 4.5* | 5.4 | 3.9 | 5.2 | 2.0* |
Painb | 7.3 | 6.1 | 7.3 | 4.1* | 6.0 | 3.8 | 5.8 | 2.1* |
Disability index (HAQ)c | 2.0 | 1.9 | 1.9 | 1.5* | 1.5 | 1.3 | 1.5 | 0.8* |
CRP (mg/dL) | 3.9 | 4.3 | 4.6 | 1.8* | 1.0 | 0.9 | 1.0 | 0.4* |
The time course of ACR 20 response for Study RA-III is shown in Figure 1.
In Study RA-III, 85% of patients with ACR 20 responses at week 24 maintained the response at 52 weeks. The time course of ACR 20 response for Study RA-I and Study RA-II were similar.
Figure 1: Study RA-III ACR 20 Responses over 52 Weeks
In Study RA-IV, 53% of patients treated with HUMIRA 40 mg every other week plus standard of care had an ACR 20 response at week 24 compared to 35% on placebo plus standard of care (p<0.001). No unique adverse reactions related to the combination of HUMIRA (adalimumab) and other DMARDs were observed.
In Study RA-V with MTX naïve patients with recent onset rheumatoid arthritis, the combination treatment with HUMIRA plus MTX led to greater percentages of patients achieving ACR responses than either MTX monotherapy or HUMIRA monotherapy at Week 52 and responses were sustained at Week 104 (see Table 4).
Table 4: ACR Response in Study RA-V (Percent of Patients) Response | MTXb N=257 | HUMIRAc N=274 | HUMIRA/MTX N=268 |
- aMajor clinical response is defined as achieving an ACR70 response for a continuous six month period
- bp<0.05, HUMIRA/MTX vs. MTX for ACR 20
p<0.001, HUMIRA/MTX vs. MTX for ACR 50 and 70, and Major Clinical Response
- cp<0.001, HUMIRA/MTX vs. HUMIRA
|
ACR20
| 63% 56% | 54% 49% | 73% 69% |
ACR50
| 46% 43% | 41% 37% | 62% 59% |
ACR70
| 27% 28% | 26% 28% | 46% 47% |
Major Clinical Response a | 28% | 25% | 49% |
At Week 52, all individual components of the ACR response criteria for Study RA-V improved in the HUMIRA/MTX group and improvements were maintained to Week 104.
Radiographic Response
In Study RA-III, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score, at month 12 compared to baseline. At baseline, the median TSS was approximately 55 in the placebo and 40 mg every other week groups. The results are shown in Table 5. HUMIRA/MTX treated patients demonstrated less radiographic progression than patients receiving MTX alone at 52 weeks.
Table 5: Radiographic Mean Changes Over 12 Months in Study RA-III | Placebo/MTX | HUMIRA/MTX 40 mg every other week | Placebo/MTX-HUMIRA/MTX (95% Confidence Interval*) | P-value** |
*95% confidence intervals for the differences in change scores between MTX and HUMIRA. **Based on rank analysis |
Total Sharp score | 2.7 | 0.1 | 2.6 (1.4, 3.8) | <0.001 |
Erosion score | 1.6 | 0.0 | 1.6 (0.9, 2.2) | <0.001 |
JSN score | 1.0 | 0.1 | 0.9 (0.3, 1.4) | 0.002 |
In the open-label extension of Study RA-III, 77% of the original patients treated with any dose of HUMIRA were evaluated radiographically at 2 years. Patients maintained inhibition of structural damage, as measured by the TSS. Fifty-four percent had no progression of structural damage as defined by a change in the TSS of zero or less.
Fifty-five percent (55%) of patients originally treated with 40 mg HUMIRA every other week have been evaluated radiographically at 5 years. Patients had continued inhibition of structural damage with 50% showing no progression of structural damage defined by a change in the TSS of zero or less.
In Study RA-V, structural joint damage was assessed as in Study RA-III. Greater inhibition of radiographic progression, as assessed by changes in TSS, erosion score and JSN was observed in the HUMIRA/MTX combination group as compared to either the MTX or HUMIRA monotherapy group at Week 52 as well as at Week 104 (see Table 6).
Table 6: Radiographic Mean Change* in Study RA-V | | MTXa N=257 | HUMIRAa,b N=274 | HUMIRA/MTX N=268 |
- *mean (95% confidence interval)
- ap<0.001, HUMIRA/MTX vs. MTX at 52 and 104 weeks and for HUMIRA/MTX vs. HUMIRA at 104 weeks
- bp<0.01, for HUMIRA/MTX vs. HUMIRA at 52 weeks
|
52 Weeks | Total Sharp score | 5.7 (4.2, 7.3) | 3.0 (1.7, 4.3) | 1.3 (0.5, 2.1) |
| Erosion score | 3.7 (2.7, 4.8) | 1.7 (1.0, 2.4) | 0.8 (0.4, 1.2) |
| JSN score | 2.0 (1.2, 2.8) | 1.3 (0.5, 2.1) | 0.5 (0.0, 1.0) |
104 Weeks | Total Sharp score | 10.4 (7.7, 13.2) | 5.5 (3.6, 7.4) | 1.9 (0.9, 2.9) |
| Erosion score | 6.4 (4.6, 8.2) | 3.0 (2.0, 4.0) | 1.0 (0.4, 1.6) |
| JSN score | 4.1 (2.7, 5.4) | 2.6 (1.5, 3.7) | 0.9 (0.3, 1.5) |
Physical Function Response
In studies RA-I through IV, HUMIRA showed significantly greater improvement than placebo in the disability index of Health Assessment Questionnaire (HAQ-DI) from baseline to the end of study, and significantly greater improvement than placebo in the health-outcomes as assessed by The Short Form Health Survey (SF 36). Improvement was seen in both the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
In Study RA-III, the mean (95% CI) improvement in HAQ-DI from baseline at week 52 was 0.60 (0.55, 0.65) for the HUMIRA patients and 0.25 (0.17, 0.33) for placebo/MTX (p<0.001) patients. Sixty-three percent of HUMIRA-treated patients achieved a 0.5 or greater improvement in HAQ-DI at week 52 in the double-blind portion of the study. Eighty-two percent of these patients maintained that improvement through week 104 and a similar proportion of patients maintained this response through week 260 (5 years) of open label treatment. Mean improvement in the SF-36 was maintained through the end of measurement at week 156 (3 years).
In Study RA-V, the HAQ-DI and the physical component of the SF-36 showed greater improvement (p<0.001) for the HUMIRA/MTX combination therapy group versus either the MTX monotherapy or the HUMIRA monotherapy group at Week 52, which was maintained through Week 104.
Psoriatic Arthritis
The safety and efficacy of HUMIRA was assessed in two randomized, double-blind, placebo controlled studies in 413 patients with psoriatic arthritis. Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg HUMIRA was administered every other week.
Study PsA-I enrolled 313 adult patients with moderately to severely active psoriatic arthritis (>3 swollen and >3 tender joints) who had an inadequate response to NSAID therapy in one of the following forms: (1) distal interphalangeal (DIP) involvement (N=23); (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis) (N=210); (3) arthritis mutilans (N=1); (4) asymmetric psoriatic arthritis (N=77); or (5) ankylosing spondylitis-like (N=2). Patients on MTX therapy (158 of 313 patients) at enrollment (stable dose of ≤30 mg/week for >1 month) could continue MTX at the same dose. Doses of HUMIRA 40 mg or placebo every other week were administered during the 24-week double-blind period of the study.
Compared to placebo, treatment with HUMIRA resulted in improvements in the measures of disease activity (see Tables 7 and 8). Among patients with psoriatic arthritis who received HUMIRA, the clinical responses were apparent in some patients at the time of the first visit (two weeks) and were maintained up to 88 weeks in the ongoing open-label study. Similar responses were seen in patients with each of the subtypes of psoriatic arthritis, although few patients were enrolled with the arthritis mutilans and ankylosing spondylitis-like subtypes. Responses were similar in patients who were or were not receiving concomitant MTX therapy at baseline.
Patients with psoriatic involvement of at least three percent body surface area (BSA) were evaluated for Psoriatic Area and Severity Index (PASI) responses. At 24 weeks, the proportions of patients achieving a 75% or 90% improvement in the PASI were 59% and 42% respectively, in the HUMIRA group (N=69), compared to 1% and 0% respectively, in the placebo group (N=69) (p<0.001). PASI responses were apparent in some patients at the time of the first visit (two weeks). Responses were similar in patients who were or were not receiving concomitant MTX therapy at baseline.
Table 7: ACR Response in Study PsA-I (Percent of Patients) Response | Placebo N=162 | HUMIRA* N=151 |
- *p<0.001 for all comparisons between HUMIRA and placebo
|
ACR20
| 14% 15% | 58% 57% |
ACR50
| 4% 6% | 36% 39% |
ACR70
| 1% 1% | 20% 23% |
Table 8: Components of Disease Activity in Study PsA-I | Placebo N=162 | HUMIRA* N=151 |
- *p<0.001 for HUMIRA vs. placebo comparisons based on median changes
- aScale 0-78
- bScale 0-76
- cVisual analog scale; 0=best, 100=worst
- dDisability Index of the Health Assessment Questionnaire; 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
- eNormal range: 0-0.287 mg/dL
|
Parameter: median | Baseline | 24 weeks | Baseline | 24 weeks |
Number of tender jointsa | 23.0 | 17.0 | 20.0 | 5.0 |
Number of swollen jointsb | 11.0 | 9.0 | 11.0 | 3.0 |
Physician global assessmentc | 53.0 | 49.0 | 55.0 | 16.0 |
Patient global assessmentc | 49.5 | 49.0 | 48.0 | 20.0 |
Painc | 49.0 | 49.0 | 54.0 | 20.0 |
Disability index (HAQ) d | 1.0 | 0.9 | 1.0 | 0.4 |
CRP (mg/dL)e | 0.8 | 0.7 | 0.8 | 0.2 |
Similar results were seen in an additional, 12-week study in 100 patients with moderate to severe psoriatic arthritis who had suboptimal response to DMARD therapy as manifested by ≥3 tender joints and ≥3 swollen joints at enrollment.
Radiographic Response
Radiographic changes were assessed in the psoriatic arthritis studies. Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on HUMIRA or placebo and at Week 48 when all patients were on open-label HUMIRA. A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e., not identical to the TSS used for rheumatoid arthritis), was used by readers blinded to treatment group to assess the radiographs.
HUMIRA-treated patients demonstrated greater inhibition of radiographic progression compared to placebo-treated patients and this effect was maintained at 48 weeks (see Table 9).
Table 9: Change in Modified Total Sharp Score in Psoriatic Arthritis | Placebo
N=141
| HUMIRA
N=133
|
| Week 24 | Week 24 | Week 48 |
* <0.001 for the difference between HUMIRA, Week 48 and Placebo, Week 24 (primary analysis) |
Baseline mean | 22.1 | 23.4 | 23.4 |
Mean Change ± SD | 0.9 ± 3.1 | -0.1 ± 1.7 | -0.2 ± 4.9* |
Physical Function Response
In Study PsA-I, physical function and disability were assessed using the HAQ Disability Index (HAQ-DI) and the SF-36 Health Survey. Patients treated with 40 mg of HUMIRA every other week showed greater improvement from baseline in the HAQ-DI score (mean decreases of 47% and 49% at Weeks 12 and 24 respectively) in comparison to placebo (mean decreases of 1% and 3% at Weeks 12 and 24 respectively). At Weeks 12 and 24, patients treated with HUMIRA showed greater improvement from baseline in the SF-36 Physical Component Summary score compared to patients treated with placebo, and no worsening in the SF-36 Mental Component Summary score. Improvement in physical function based on the HAQ-DI was maintained for up to 84 weeks through the open-label portion of the study.
Ankylosing Spondylitis
The safety and efficacy of HUMIRA 40 mg every other week was assessed in 315 adult patients in a randomized, 24 week double-blind, placebo-controlled study in patients with active ankylosing spondylitis (AS) who had an inadequate response to glucocorticoids, NSAIDs, analgesics, methotrexate or sulfasalazine. Active AS was defined as patients who fulfilled at least two of the following three criteria: (1) a Bath AS disease activity index (BASDAI) score ≥4 cm, (2) a visual analog score (VAS) for total back pain ≥ 40 mm, and (3) morning stiffness ≥ 1 hour. The blinded period was followed by an open-label period during which patients received HUMIRA 40 mg every other week subcutaneously for up to an additional 28 weeks.
Improvement in measures of disease activity was first observed at Week 2 and maintained through 24 weeks as shown in Figure 2 and Table 10.
Responses of patients with total spinal ankylosis (n=11) were similar to those without total ankylosis.
Figure 2: ASAS 20 Response By Visit, Study AS-I
At 12 weeks, the ASAS 20/50/70 responses were achieved by 58%, 38%, and 23%, respectively, of patients receiving HUMIRA, compared to 21%, 10%, and 5% respectively, of patients receiving placebo (p <0.001). Similar responses were seen at Week 24 and were sustained in patients receiving open-label HUMIRA for up to 52 weeks.
A greater proportion of patients treated with HUMIRA (22%) achieved a low level of disease activity at 24 weeks (defined as a value <20 [on a scale of 0 to 100 mm] in each of the four ASAS response parameters) compared to patients treated with placebo (6%).
Table 10: Components of Ankylosing Spondylitis Disease Activity | Placebo N=107 | HUMIRA N=208 |
- aPercent of subjects with at least a 20% and 10-unit improvement measured on a Visual Analog Scale (VAS) with 0 = “none” and 100 = “severe”
- bmean of questions 5 and 6 of BASDAI (defined in ‘d’)
- cBath Ankylosing Spondylitis Functional Index
- dBath Ankylosing Spondylitis Disease Activity Index
- eBath Ankylosing Spondylitis Metrology Index
- fC-Reactive Protein (mg/dL)
- *statistically significant for comparisons between HUMIRA and placebo at Week 24
|
| Baseline mean | Week 24 mean | Baseline mean | Week 24 mean |
ASAS 20 Response Criteria* | | | | |
Patient’s Global Assessment of Disease Activitya* | 65 | 60 | 63 | 38 |
Total back pain* | 67 | 58 | 65 | 37 |
Inflammationb* | 6.7 | 5.6 | 6.7 | 3.6 |
BASFIc* | 56 | 51 | 52 | 34 |
BASDAIdscore* | 6.3 | 5.5 | 6.3 | 3.7 |
BASMIe score* | 4.2 | 4.1 | 3.8 | 3.3 |
Tragus to wall (cm) | 15.9 | 15.8 | 15.8 | 15.4 |
Lumbar flexion (cm) | 4.1 | 4.0 | 4.2 | 4.4 |
Cervical rotation (degrees) | 42.2 | 42.1 | 48.4 | 51.6 |
Lumbar side flexion (cm) | 8.9 | 9.0 | 9.7 | 11.7 |
Intermalleolar distance (cm) | 92.9 | 94.0 | 93.5 | 100.8 |
CRPf* | 2.2 | 2.0 | 1.8 | 0.6 |
A second randomized, multicenter, double-blind, placebo-controlled study of 82 patients with ankylosing spondylitis showed similar results.
Patients treated with HUMIRA achieved improvement from baseline in the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score (-3.6 vs. -1.1) and in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) score (7.4 vs. 1.9) compared to placebo-treated patients at Week 24.
Crohn’s Disease
The safety and efficacy of multiple doses of HUMIRA were assessed in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomized, double-blind, placebo-controlled studies. Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted, and 79% of patients continued to receive at least one of these medications.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies. In Study CD-I, 299 TNF-blocker naïve patients were randomized to one of four treatment groups: the placebo group received placebo at Weeks 0 and 2, the 160/80 group received 160 mg HUMIRA at Week 0 and 80 mg at Week 2, the 80/40 group received 80 mg at Week 0 and 40 mg at Week 2, and the 40/20 group received 40 mg at Week 0 and 20 mg at Week 2. Clinical results were assessed at Week 4.
In the second induction study, Study CD-II, 325 patients who had lost response to, or were intolerant to, previous infliximab therapy were randomized to receive either 160 mg HUMIRA at Week 0 and 80 mg at Week 2, or placebo at Weeks 0 and 2. Clinical results were assessed at Week 4.
Maintenance of clinical remission was evaluated in Study CD-III. In this study, 854 patients with active disease received open-label HUMIRA, 80 mg at week 0 and 40 mg at Week 2. Patients were then randomized at Week 4 to 40 mg HUMIRA every other week, 40 mg HUMIRA every week, or placebo. The total study duration was 56 weeks. Patients in clinical response (decrease in CDAI ≥70) at Week 4 were stratified and analyzed separately from those not in clinical response at Week 4.
Induction of Clinical Remission
A greater percentage of the patients treated with 160/80 mg HUMIRA achieved induction of clinical remission versus placebo at Week 4 regardless of whether the patients were TNF blocker naïve (CD-I), or had lost response to or were intolerant to infliximab (CD-II) (see Table 11).
Table 11: Induction of Clinical Remission in Studies CD-I and CD-II (Percent of Patients) | CD-I | CD-II |
Clinical remission is CDAI score < 150; clinical response is decrease in CDAI of at least 70 points.
- *p<0.001 for HUMIRA vs. placebo pairwise comparison of proportions
- **p<0.01 for HUMIRA vs. placebo pairwise comparison of proportions
|
| Placebo N=74 | HUMIRA 160/80 mg N=76 | Placebo N=166 | HUMIRA 160/80 mg N=159 |
Week 4 | | | | |
Clinical remission | 12% | 36%* | 7% | 21%* |
Clinical response | 34% | 58%** | 34% | 52%** |
Maintenance of Clinical Remission
In Study CD-III at Week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis. At Weeks 26 and 56, greater proportions of patients who were in clinical response at Week 4 achieved clinical remission in the HUMIRA 40 mg every other week maintenance group compared to patients in the placebo maintenance group (see Table 12). The group that received HUMIRA therapy every week did not demonstrate significantly higher remission rates compared to the group that received HUMIRA every other week.
Table 12: Maintenance of Clinical Remission in CD-III (Percent of Patients) | Placebo | 40 mg HUMIRA every other week |
| N=170 | N=172 |
Clinical remission is CDAI score < 150; clinical response is decrease in CDAI of at least 70 points.
- *p<0.001 for HUMIRA vs. placebo pairwise comparisons of proportions
|
Week 26 | | |
Clinical remission | 17% | 40%* |
Clinical response | 28% | 54%* |
Week 56 | | |
Clinical remission | 12% | 36%* |
Clinical response | 18% | 43%* |
Of those in response at Week 4 who attained remission during the study, patients in the HUMIRA every other week group maintained remission for a longer time than patients in the placebo maintenance group. Among patients who were not in response by Week 12, therapy continued beyond 12 weeks did not result in significantly more responses.
|