Centocor, Inc (HORSHAM, Pennsylvania), a wholly owned subsidiary of Johnson & Johnson, announced that patients with active psoriatic arthritis (PsA) receiving monthly subcutaneous (SC) injections of golimumab experienced significant and sustained improvements in the joint and skin manifestations of the disease, according to findings from the largest phase III biologic study (GO-REVEAL trial) in PsA subjects. At week 14 of the 405 adult patient study, 51% of patients receiving golimumab 50 mg and 45% receiving golimumab 100 mg experienced at least 20% improvement in ACR20 compared with 9% of patients receiving placebo (P <.001 for both comparisons). Golimumab-treated patients maintained significant improvements in arthritis through week 24 and showed substantial and sustained improvements in skin and nail psoriatic disease (as measured by PASI 75 in patients with baseline body surface area with psoriasis of at least 3%, and the Nail Psoriasis Severity Index [NAPSI]).

Initial improvements as measured by ACR20 at week 14 persisted through week 24, and at which time, 52% and 61% of patients given golimumab 50 mg and 100 mg, respectively, achieved ACR20 compared with 12% of patients on placebo (P <.001); significant improvements were observed in ACR50 and ACR70 measures. At week 14, 30% and 28% of patients receiving golimumab 50 mg and 100 mg, respectively, achieved ACR50 compared with 2% receiving placebo (P <.001). At week 24, the results persisted with 32% and 38% of patients given golimumab 50 mg and 100 mg, respectively, achieving ACR50 compared with 4% given placebo (P <.001). ACR70 was achieved at week 14 by 12% of patients on golimumab 50 mg and 17% on golimumab 100 mg compared with 1% of patients on placebo (P <.001). At week 24, 19% of patients receiving golimumab 50 mg and 21% receiving 100 mg achieved ACR70 compared with 1% of patients receiving placebo (P <.001).

Patients receiving both doses of golimumab also experienced improvements in enthesitis (inflammation of a tendon, ligament, or joint capsule insertion to the bone) and dactylitis (swelling of digits in hands or feet). At baseline, 78% (placebo group), 75% (golimumab 50 mg group) and 79% (golimumab 100 mg group) of study subjects presented with enthesitis (at least one tender body enthesitis site) as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index modified for PsA; 34% (placebo group), 34% (golimumab 50 mg group), and 34% (golimumab 100 mg group) of subjects presented with dactylitis at baseline. Both golimumab doses were significantly better than placebo in improvement of enthesitis as measured by percent change in the PsA modified MASES index. At week 14, the mean improvement in enthesitis was 44% among patients given golimumab 50 mg and 33% among patients given 100 mg compared with a 19% worsening in placebo patients (P <.001). At week 24, the mean improvements in enthesitis were 46% for patients receiving golimumab 50 mg and 52% among patients receiving golimumab 100 mg, compared with a 13% worsening in placebo patients (P <.001). Golimumab 100 mg dose significantly improved dactylitis measured by percent change in dactylitis score compared with placebo at week 14 (66% vs 5%; P = .009) and at week 24 (82% vs 28%; P <.001). There was a trend towards improvement in dactylitis for golimumab 50 mg dose at weeks 14 and 24, but the comparisons with placebo did not reach statistical significance.

In addition to improvements in joint symptoms, a substantial proportion of golimumab-treated patients experienced significant improvement in skin manifestations of the disease. Among a subset of the study population with at least 3% of body surface area involved by psoriasis at baseline, 40% and 58% of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3% of patients receiving placebo (P < .001). At week 24, PASI 75 responses improved to 56% (golimumab 50 mg) and 66% (golimumab 100 mg), compared with 1% of placebo patients (P <.001). In additional analyses, patients given golimumab 50 mg and 100 mg also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.

The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28). After 14 weeks of treatment, 66% of patients given golimumab 50 mg and 67% given golimumab 100 mg were DAS28 responders, compared with 24% of patients on placebo (P <.001). At week 24, 64% and 78% of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24% of patients receiving placebo (P <.001). Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean improvement of 0.31 and patients receiving golimumab 100 mg experienced a mean improvement of 0.38 in HAQ score, compared with an improvement of only 0.04 among placebo patients (P <.001). At week 24, the improvements were 0.33 and 0.39 in the respective treatment groups, compared with a worsening in HAQ score of -0.01 among placebo patients (P <.001). An improvement in HAQ of at least 0.3 indicates clinically meaningful improvement in physical function.

Subjects in the GO-REVEAL trial with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter were randomly assigned to receive SC injections of placebo or golimumab 50 or 100 mg at weeks 0, 4, 8, 12, 16, and 20. At week 16, patients with inadequate arthritis response were switched from placebo to golimumab 50 mg or from golimumab 50 mg to 100 mg. The primary endpoint was ACR20 response at week 14 for both combined and individual golimumab dose groups versus placebo.

Through week 24, the placebo-controlled portion of the study, golimumab was generally well-tolerated. Injection site reactions occurred in 5% of patients receiving golimumab and 3% of patients receiving placebo. One case of prostate cancer and two cases of basal cell carcinoma were reported in golimumab-treated patients. There were no reports of tuberculosis or opportunistic infections through week 24.