Background/Purpose:

Golimumab (GOL) has shown its efficacy and safety in various
randomized clinical trials with accurately selected patients. Data from daily
clinical practice in Germany are still lacking.

To gather data from German patients with a known
moderate to severe inflammatory rheumatic disease (RA, PsA,
AS) treated with GOL sc in daily clinical practice.
The aim of this non-interventional, prospective, multicenter study was to show
the safety, effectiveness, socio- and health economic parameters, and quality
of life reported by patients in a real-life setting.

Methods:

1,598 patients with RA, AS or PsA
at 168 German study sites were enrolled in GO-NICE. The study explored days of
sick leave, ability to work, hospitalizations, data of quality of life and
clinical effectiveness by DAS28, PsARC and BASDAI as
well as safety of GOL 50 mg sc therapy. This 3rd
interim analysis evaluates all patients treated for at least 12 months or more
until 31st March 2014.

Results:

A total of 1,218 patients met the criteria for the 3rd
interim analysis.

RA (n=401, 33%): The mean age was 54.9 years, 26.9%
were male. The DAS28 was initially at 5.0 and dropped within 24 months to 3.0.
After 3 months of therapy, 35.8% of patients were in remission (DAS28 <2.6),
after 24 months 42.4%. 46.1% of the RA patients worked full or part-time at
baseline (BL).

PsA (n=408, 33.6%): The mean age was 50.4 yrs, 46.3% were male. 159 patients had a nail involvement
(39%), 86 dactylitis (21.1%) and 57 enthesitis (14%). 52.3% of PsA-patients had a good response
(mod. PsARC) after 3 months with increase to 67.8% at 24 month. 55.0%
of PsA-patients worked fully or part-time al BL.

AS (n=407, 33.5%): The mean age was 42.9 years, 67.1%
were male. The most common extra-articular manifestations were iritis (16%), enthesitis (13.8%),
CED (6.1%) and dactylitis (3.9%). The mean BASDAI
score (1-10) decreased from 5.1 (month 0) to 2.3 (24 months). 69.9% of AS
patients were employed fully or part-time at BL.

Days of absenteeism from work dropped in RA patients
from 16.0 to 8.2 (-48.8%) in PsA from 10.0 to 3.2
(-68.0%) and AS from 14.4 to 4.1 days (-71.7%) within the past six months. The
disease impact on quality of work within past 6 months, determined by 0 (no
impact) to 10 (very severe impact) decreased within the 24 months treatment
from 5.0 to 2.4 (RA-) from 4.7 to 2.2 (PsA-) and from
4.0 to 2.2 (AS-patients). The proportion of patients who required
hospitalization decreased from 11.4% to 1.2%, physiotherapy from 24.4% to
10.7%, and massage treatment from 11.3% to 3.4% within the first year of
treatment. An improvement of the quality of life (EQ-5D-3L) was seen in all
three patient groups in all five domains after 6 months and was maintained over
the time.

After 24 months, 80% of the rheumatologists rated the
treatment course of as "successful", 10-15% as" partially
successful", and less than 5% as "unsuccessful".

The safety profile of GOL was consistent with that
observed in other studies of GOL.

Conclusion:

GOL sc once monthly is an
effective treatment in patients with RA, PsA and AS
in a real-life setting in Germany. It shows remarkable improvements in health
economic and patient-reported quality of life parameters. No new safety signals
were detected.