Humira

Clinical Pharmacology

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Clinical Pharmacology

Humira

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

Study RA-III ACR 20 Responses over 52 Weeks - illustration

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	MTX^b N=257	HUMIRA^c N=274	HUMIRA/MTX N=268
ACR20
Week 52	63%	54%	73%
Week 104	56%	49%	69%
ACR50
Week 52	46%	41%	62%
Week 104	43%	37%	59%
ACR70
Week 52	27%	26%	46%
Week 104	28%	28%	47%
Major Clinical Response^a	28%	25%	49%
^aMajor clinical response is defined as achieving an ACR70 response for a continuous six monthperiod ^b p < 0.05, HUMIRA/MTX vs. MTX for ACR 20p < 0.001, HUMIRA/MTX vs. MTX for ACR 50 and 70, and Major Clinical Response ^cp < 0.001, HUMIRA/MTX vs. HUMIRA

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**
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
95% confidence intervals for the differences in change scores between MTX and HUMIRA. *Based on rank analysis