SAN FRANCISCO, California— More than half of active psoriatic arthritis (PsA) patients receiving subcutaneous injections every 4 weeks of 50 mg or 100 mg of golimumab (CNTO 148, Centocor, Inc), a next-generation human anti-TNFα monoclonal antibody, showed joint and skin improvements that lasted at least 1 year, according to new research presented at the American College of Rheumatology (ACR) annual scientific meeting in San Francisco.¹

“These results demonstrate long-term efficacy of every-4-week dosing with golimumab in improving physical symptoms and functional ability as well as improving quality of life,” said study author Arthur Kavanaugh, MD, a professor of medicine at the University of California at San Diego School of Medicine, in a press release.  “The sustained effects of golimumab as demonstrated in these study findings are encouraging for both the physicians treating this condition and for the many patients living with this potentially debilitating disease.”

A second study showed this novel TNF-inhibitor also improves physical function and health-related quality of life (HRQol) among PsA patients,² and a third study³ presented at the meeting found that PsA patients receiving subcutaneous injections of 50 mg and 100 mg golimumab every 4 weeks also showed improvements in psoriatic nail changes, enthesitis, and dactylitis.

Golimumab holds PsA in check

In the first study, dubbed Golimumab-A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL), 52% and 61% of PsA patients receiving golimumab 50 mg and 100 mg, respectively, achieved an ACR20 response at week 24, compared with 12% of patients receiving placebo. Through 1 year, 78% of patients continuing in the golimumab 50 mg group and 74% of patients continuing in the golimumab 100 mg group achieved an ACR20 response.

Thirty-two percent of patients receiving golimumab 50 mg and 38% of patients in the 100 mg arm achieved ACR50 at week 24, compared with 4% of patients receiving placebo, the study showed.  Additionally, 57% of PsA patients receiving 50 mg of golimumab and 53% of patients in the 100 mg group reached ACR50 at 1 year.  Nineteen percent of patients receiving 50 mg golimumab and 21% of patients receiving 100 mg of golimumab achieved ACR70 at 24 weeks compared with 1% of patients receiving placebo, the study showed. At 1 year, 43% of patients receiving golimumab 50 mg and 31% of patients receiving golimumab 100 mg achieved an ACR70.

Improvements in DAS28, skin changes seen at 1 year

The majority of patients treated with golimumab every 4 weeks experienced improvements in Disease Activity Score 28 (DAS28) response.  At 1 year, 93% of patients in the 50 mg arm and 86% of patients in the 100 mg arm were deemed DAS28 responders, the study showed

At 1 year, 62% and 69% of patients continuing in the golimumab 50 mg and 100 mg dose groups, respectively, achieved a Psoriasis Area and Severity Index score of 75 (PASI75), GO REVEAL found.

Physical function and quality of life improvements at 6 months

In the second study,  PsA patients who recieved 50 mg and 100 mg of golimumab every 4 weeks significantly improved their physical function and HRQoL by week 14, and this improvement was maintained through week 24, when compared with patients who received placebo.

“Despite the short course of treatment and follow up, [golimumab] significantly improved self-reported productivity in patients with active PsA, and reduced time lost from work for their caregivers through week 24,” report researchers who were led by Phillip Mease, MD, of Seattle Rheumatology Associates at Swedish Medical Center in Washington State. In this study, there was no effect on healthcare resource utilization, employability, and time lost from work seen among patients treated with golimumab through week 24.

In the second study, adults with PsA were randomized to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks. At baseline, the researchers assessed the single worst psoriasis-affected nail (target) using the Nail Psoriasis Severity Index (NAPSI). They used the Nail Physician's Global Assessment (PGA) to evaluate all fingernails. Moreover, they assessed dactylitis in each of the 20 digits of the hands and feet and scored enthesitis tenderness in 15 body sites via the PsA-modified (plantar fascia added) Maastricht Ankylosing Spondylitis Enthesitis Score (MASES).

Both golimumab arms had higher target nail NAPSI median percent changes from baseline at week 24, when compared with placebo. Nail PGA improved in 60% of patients in the golimumab 50 mg and 63% of patients in the golimumab 100 mg group, compared with 18% in the placebo group. Dactylitis score median percent change from baseline at week 24 was 100 for both golimumab 50 mg and 100 mg versus 42 for placebo, the study showed. This was only statistically significant in the golimumab 100 mg group (P <.001). Enthesitis score median percent change from baseline at week 24 was 60 and 67 for the golimumab 50 mg and 100 mg groups, respectively, compared with 12 for the placebo group, the study showed.

In sum, “golimumab administered as a monthly subcutaneous injection at doses of 50 and 100 mg significantly improved psoriatic nail changes and enthesitis in patients with active PsA,” the study authors conclude. “Both golimumab doses also improved dactylitis, but statistical significance was achieved only with the golimumab 100 mg dose for this variable.”

The Biologics License Application (BLA) and Marketing Authorization Application (MAA) for golimumab are currently under review by the US Food and Drug Administration (FDA).

One-Year Results from GO-REVEAL

	Placebo	Golimumab 50 mg	Golimumab 100 mg
Week 24*
ACR20, % pts	12.4	52.1	61.0
HAQ score, mean improvement	-0.01	0.33	0.39
ACR50, % pts	3.5%	32.2	37.7
ACR70, % pts	0.9%	18.5	21.2
DAS28 responders (moderate and good), % pts	23.9%	64.4	78.1
PASI75 response	1.4%	55.9	66.0
Week 52†,‡		n=102	n=135
ACR20, % pts	–	78.4	74.1
HAQ score, mean improvement	–	0.49	0.45
ACR50, % pts	–	56.9	52.6
ACR70, % pts	–	43.1	31.1
DAS28 responders (moderate and good), % pts	–	92.8	86.0
PASI75 response, % pts	–	62.0	69.3

*All comparisons at wk 24 between GLM 50 mg vs PBO and GLM 100 mg vs PBO were significant at a p-value of P <.001.
†GLM 50 mg only: For wk 24 all pts randomized to GLM 50 mg are included; for wk 52, only pts randomized to GLM 50 mg and who did not enter EE are included.
‡ GLM 100 mg: For wk 24 and wk 52, all pts randomized to GLM 100 mg regardless of whether they entered EE are included.

Adapted from: Kavanaugh A, et al. American College of Rheumatology 2008 Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Presentation 671.

References

1. Kavanaugh A, Mease P,  Krueger GG, et al. Golimumab administered subcutaneously every 4 weeks In psoriatic arthritis patients: 52-week efficacy and safety results of the randomized, placebo-controlled GO-REVEAL study. Presented at: American College of Rheumatology 2008 Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Presentation 671.
2. Mease P, McInnes I, Krueger GG, et al. Golimumab significantly improves physical function, health-related quality of life, productivity and reduces time lost from work for caregivers in patients with active psoriatic arthritis. Presented at: American College of Rheumatology 2008 Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Presentation 1096.
3. Gladman D, Kavanaugh A, McInnes I, et al. Golimumab administered every four weeks as a subcutaneous injection in psoriatic arthritis: nail, enthesitis, and dactylitis response in the randomized placebo controlled GO-REVEAL study. Presented at: American College of Rheumatology 2008 Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA. Presentation 1097.