Pivotal Studies in Psoriatic Arthritis

Cure Arthritis Naturally

Cure Arthritis Naturally

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Psoriatic arthritis is a chronic, inflammatory arthritis associated with psoriasis. The pathogenic mechanisms linking psoriasis and arthritis are not yet fully characterized, although TNF has been implicated in the process. TNF can be found in significantly elevated concentrations in the joints and psoriatic plaques of patients with PsA and has been validated as an appropriate therapeutic target of this disease (Mease 2002, 2005a). The management of patients with PsA requires attention to both skin and joint manifestations. ADEPT (Adalimumab Effectiveness in Psoriatic Arthritis Trial) was a randomized, double-blind, placebo-controlled, multicenter trial that evaluated the safety and efficacy of adalimumab as monotherapy or in combination with MTX compared with placebo or placebo plus MTX in the treatment of active PsA by measuring both skin and joint response. A total of 313 patients with moderately to severely active PsA who failed nonsteroidal anti-inflammatory drug therapy were stratified according to MTX use (yes or no) and degree of psoriasis involvement (>3% or <3% of body surface area) at baseline, and were subsequently randomized to receive adalimumab 40 mg or placebo e.o.w. for 24 weeks. Significantly superior ACR responses were observed in patients treated with adalimumab than in those treated with placebo at all time points (Fig. 3.5a). Among the subset a

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Placebo Adalimumab Placebo Adaltmumab n=69 n=69 n=69 n=69

Week 12 Week 24

Fig. 3.6. Changes in modified total Sharp score (mTSS) at Weeks 24 and 48. *P < 0.001 placebo versus adalimumab using a ranked analysis of covariance (ADEPT Trial) (Mease et al. 2005a, 2005c)

Placebo Adalimumab Placebo Adaltmumab n=69 n=69 n=69 n=69

Week 12 Week 24

Fig. 3.5. Results from the ADEPT study: a Percentage of patients with psoriatic arthritis who met American College of Rheumatology (ACR) ACR20, 50, 70 response criteria at Weeks 12 and 24. *P < 0.001 placebo versus adalimumab, adjusted for baseline methotrexate use and extent of psoriasis at baseline. b Percentage of patients with psoriatic arthritis and >3 % body surface area psoriasis involvement at baseline who met Psoriasis Area and Severity Index (PASI) 50, 75, 90 response criteria at Weeks 12 and 24. *P <0.001 placebo versus adalimumab, adjusted for baseline methotrexate use. (Reproduced with permission from Mease et al. 2005a)

of patients with 3 % body surface area affected by psoriasis, Psoriasis Area and Severity Index (PASI) response rates also were significantly improved (Fig. 3.5b). In this same subset of patients, the physician's global assessment of psoriasis resulted in ratings of the lesions as clear or almost clear in 71 % of the 70 adalimumab-treated patients compared with only 12 % of the 70 placebo-treated patients at Week 24. Adalimumab treatment also resulted in significant inhibition of structur

Fig. 3.6. Changes in modified total Sharp score (mTSS) at Weeks 24 and 48. *P < 0.001 placebo versus adalimumab using a ranked analysis of covariance (ADEPT Trial) (Mease et al. 2005a, 2005c)

al changes on radiographs. The mean change in the modified TSS in patients who had both baseline and Week 24 radiographs was -0.2 for patients receiving adalimumab versus 1.0 for patients receiving placebo. Adalimumab treatment also significantly improved disability and QOL measures in patients with moderately to severely active PsA (Mease et al. 2005a).

In an ongoing OLE phase of this trial, all patients who continued received adalimumab 40 mg e.o.w. Response rates were maintained over 48 weeks of treatment for those patients initially treated with adalimu-mab. The percentage of patients achieving ACR20, ACR50, and ACR70 were 61 %, 46%, and 31 %, respectively, for adalimumab-treated patients, and 54 %, 37 %, and 21 %, respectively, for those patients originally receiving placebo who were switched to adalimumab. Of 152 placebo- and 144 adalimumab-treated patients who had radiographs at baseline and 24 weeks, 141 and 133, respectively, had radiographs taken at Week 48. Notably, the mean change in modified TSS at Week 24 was maintained to Week 48 (Fig. 3.6). At Week 48, the changes in joint space narrowing scores and in erosion scores were 0.4 and 0.5, respectively, for placebo patients and -0.1 and -0.1 for adalimumab patients (Mease et al. 2005b, 2005c).

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Arthritis Joint Pain

Arthritis Joint Pain

Arthritis is a general term which is commonly associated with a number of painful conditions affecting the joints and bones. The term arthritis literally translates to joint inflammation.

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