COPENHAGEN, Denmark—Psoriatic arthritis patients treated with golimumab (Simponi^®, Centocor Ortho Biotech Inc) have achieved and maintained significant improvements in signs and symptoms of disease out to week 104 of therapy. Researchers reported this finding at the Annual European Congress of Rheumatology (EULAR).¹

“We can say that golimumab, in 50 and 100 mg doses administered subcutaneously every four weeks for 104 weeks, maintained a good effect for improving the signs and symptoms of active psoriatic arthritis, including skin disease, nail involvement and dactylitus,” said presenter and lead investigator Arthur Kavanaugh, MD, professor of clinical medicine at the University of California in San Diego School of Medicine in La Jolla, California.

“Golimumab therapy was also generally well-tolerated. We will continue watching these patients out to 5 years,” Dr. Kavanaugh added.

The investigators randomized PsA patients with >3 swollen and >3 tender joints and with psoriatic skin lesions to subcutaneous placebo or golimumab (50 or 100 mg) every 4 weeks. At week 16, those subjects who had not achieved an adequate early response to treatment entered early escape, and they began treatment with golimumab 50 mg (placebo subjects) or golimumab 100 mg (golimumab 50 mg subjects).

All subjects received golimumab from week 24 forward. The trial was unblinded to the investigators and patients when all patients reached week 52 of treatment. Investigators were free to escalate dosing of golimumab 50 mg to 100 mg according to ongoing clinical assessment of individual subjects.

EULAR report included over 400 psoriatic arthritis patients

The researchers in this study evaluated the data for the subjects who were randomized to golimumab 50 or 100 mg and who stayed on the same dose throughout the 104 weeks, and for subjects who changed their treatment from 50 to 100 mg.

They randomized 405 patients with active psoriatic arthritis, 113 to placebo, 146 to golimumab 50 mg and 146 to golimumab 100 mg.

As reported previously, golimumab was significantly better than placebo in improving signs and symptoms of psoriatic arthritis at week 24, and golimumab efficacy was maintained through week 52.

Through week 104, subjects randomized to golimumab 50 mg or 100 mg and continuing on the same dose throughout maintained high levels of response. Golimumab 50 mg subjects who switched to 100 mg in early escape or by dose escalation also achieved clinically meaningful responses (See table).

	GLM 50 mg only	GLM 50=>100 mg	GLM 100 mg only
WK 52
ACR 20	80/102 (78.4%)	11/26 (42.3%)	93/115 (80.9%)
HAQ score, mean (SD) improvement	n=100, 0.49 (0.55)	n=26, 0.20 (0.49)	n=113, 0.50 (0.54)
ACR50	58/102 (56.9%)	7/26 (26.9%)	68/115 (59.1%)
ACR70	44/102 (43.1%)	3/26 (11.5%)	41/115 (35.7%)
DAS28 responders (moderate and good)	90/97 (92.8%)	16/25 (64.0%)	100/110 (90.0%)
PASI75 response	44/71 (62.0%)	17/23 (73.9%)	60/86 (69.8%)
Wk 104
ACR20	64/70 (91.4%)	43/76 (56.6%)	95/130 (73.1%)
HAQ score, mean (SD) improvement	n=69, 0.54 (0.55)	n=76, 0.36 (0.57)	n=127, 0.46 (0.57)
ACR50	46/70 (65.7%)	27/76 (35.5%)	70/130 (53.8%)
ACR70	31/70 (44.3%)	17/76 (22.4%)	48/130 (36.9%)
DAS28 responders (moderate and good)	68/68 (100.0%)	60/72 (83.3%)	110/124 (88.7%)
PASI75 response	33/48 (68.8%)	35/56 (62.5%)	73/96 (76.0%)

Source: Kavanaugh et al¹

Golimumab was generally well-tolerated, with 8.6% (34/394) of golimumab-treated subjects experiencing serious adverse events through week 104. Injection site reactions were reported by 8.9% (35/394) of golimumab-treated subjects, involving 0.7% (109/16007) of total golimumab injections through week 104.

Few problems with infections or neoplasms in golimumab group

There were no reports of tuberculosis. There was one reported case of histoplasmosis in a golimumab 100 mg subject living in an endemic area, and it was successfully treated.

The investigators reported malignancies through week 104, including basal cell skin (1 patient), colon (1 patient) and small cell lung cancer (1 patient) among subjects receiving golimumab 50 mg, as well as basal cell skin (3 patients), prostate (1 patient) and small cell lung cancer (1 patient) among subjects receiving golimumab 100 mg.

There were two deaths though week 104, one an accident (golimumab 50 mg) and 1 due to small cell lung cancer (golimumab 100 mg).

The authors concluded, “Patients with active PsA [psoriatic arthritis] treated with [golimumab] GLM50 and 100 mg SC q4 weeks maintained high levels of improvement through week 104. GLM was generally well-tolerated, with a safety profile similar to that observed for other anti-TNF agents.”

The study was sponsored by Centocor Ortho-Biotech, Inc.

Reference

1. Kavanaugh A, Mease P, Krueger GG, et al. Golimumab, a new, human, TNF-alpha antibody, administered subcutaneously every 4 weeks in psoriatic arthritis patients: 104-week efficacy and safety results of the randomized, placebo-controlled GO-REVEAL study. Presented at: EULAR 2009, Copenhagen, Denmark, June 12, 2009. Presentation no. OP-0195.