Table 2:
Change from baseline to month 12 (double-blind phase) or month 18 (including open-label extension) in modified Rodnan Skin Score and exploratory endpoints (intention-to-treat population; observed data)
| Double-blind phase, month 12 |
Open-label extension, month 18 |
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|---|---|---|---|---|---|---|---|---|
| Placebo (n=44) | Abatacept (n=44) | Placebo–abatacept (n=34) | Abatacept–abatacept (n=33) | |||||
|
|
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| n | Change from baseline | n | Change from baseline | n | Change from baseline | n | Change from baseline | |
| Modified Rodnan Skin Score | 38 | −3·7 (7·6) | 34 | −6·6 (6·4) | 31 | −6·3 (9·3) | 32 | −9·8 (8·1) |
| Health Assessment Questionnaire disability index* | 36 | 0·09 (0·43) | 33 | −0·09 (0·46) | 28 | 0·04 (0·47) | 32 | −0·13 (0·43) |
| Scleroderma Health Assessment Questionnaire, visual analogue scale | ||||||||
| Overall* | 35 | 13·5 (33·8) | 34 | −8·6 (34·1) | 28 | −6·2 (37·0) | 31 | −18·2 (36·7) |
| Breathing* | 35 | 16·1 (32·0) | 34 | −0·6 (35·2) | 28 | 8·8 (32·0) | 31 | 3·5 (38·5) |
| Raynaud’s* | 35 | −2·4 (36·8) | 34 | 7·2 (34·2) | 28 | 4·0 (42·2) | 31 | −9·3 (37·7) |
| Digital ulcers* | 35 | 9·3 (42·8) | 34 | −2·7 (27·0) | 28 | 3·7 (37·0) | 31 | −0·1 (22·7) |
| Gastrointestinal* | 36 | 5·2 (37·3) | 34 | 8·4 (36·8) | 28 | 14·4 (30·3) | 32 | 15·2 (46·7) |
| Physician global assessment, visual analogue scale* | 35 | −0·3 (1·9) | 34 | −1·4 (1·5) | 27 | −1·0 (2·0) | 32 | −1·3 (2·1) |
| Patient global assessment, visual analogue scale* | 35 | −0·4 (3·3) | 33 | 0·0 (2·2) | 29 | −0·6 (3·3) | 31 | −0·4 (2·1) |
| Forced vital capacity, % predicted† | 37 | −2·7% (5·5) | 32 | −1·6% (8·0) | 29 | −0·3% (6·3) | 30 | 0·9% (9·9) |
| Forced vital capacity, mL | 37 | −113·5 (202·9) | 32 | −74·4 (308·7) | 29 | −38·6 (243·9) | 30 | 1·7 (389·7) |
| Diffusion capacity of carbon monoxide, % predicted†‡ | 33 | −2·1% (10·8) | 30 | 0·7% (12·5) | 27 | −2·4% (11·7) | 29 | 0·9% (11·9) |
| Tender joint count* | 38 | −0·9 (6·5) | 34 | −1·1 (8·2 | 31 | −1·6 (3·9) | 32 | −2·5 (6·4) |
| Swollen joint count* | 38 | −1·5 (4·1) | 34 | −0·7 (3·9) | 31 | −1·5 (4·4) | 32 | −1·7 (4·2) |
| PROMIS-29 | ||||||||
| Physical function† | 35 | 0·1 (4·0) | 34 | −1·8 (3·6) | 29 | −1·3 (4·7) | 30 | −1·6 (4·7) |
| Anxiety* | 35 | −1·3 (10·1) | 34 | −4·0 (9·1) | 29 | −5·3 (9·0) | 30 | −1·5 (8·7) |
| Depression* | 35 | −0·8 (7·9) | 34 | 0·6 (7·5) | 29 | −2·9 (7·2) | 30 | 1·4 (5·9) |
| Fatigue* | 36 | −1·4 (6·7) | 34 | −1·1 (7·7) | 29 | −2·6 (7·6) | 31 | −2·5 (8·2) |
| Sleep disturbance* | 36 | −0·3 (3·6) | 34 | 0·0 (2·9) | 29 | −0·5 (4·3) | 31 | −0·4 (3·9) |
| Pain interference* | 36 | −0·8 (7·6) | 34 | −4·1 (8·4) | 28 | −1·3 (8·0) | 31 | −2·9 (6·9) |
| Social roles† | 36 | −1·5 (5·0) | 34 | −0·8 (7·1) | 28 | 0·5 (8·1) | 31 | 0·0 (8·4) |
| Pain intensity* | 36 | −0·2 (1·7) | 34 | −0·7 (2·5) | 28 | −0·7 (1·9) | 31 | −1·2 (1·9) |
| UCLA GIT 2.0, total score* | 36 | 0·0 (0·3) | 34 | 0·1 (0·3) | 28 | 0·2 (0·4) | 30 | 0·1 (0·3) |
| ACR CRISS† | 30 | 0·03 (0·00–0·93) | 29 | 0·81 (0·00–1·00) | 26 | 0·5 (0·01–0·99) | 29 | 0·99 (0·06–1·00) |
Data are mean (SD) or median (IQR). n=patients with available data for measurement. PROMIS-29=Patient-Reported Outcomes Measurement Information System-29. UCLA GIT 2.0=University of California at Los Angeles Scleroderma Clinical Trial Consortium gastrointestinal tract 2.0. ACR CRISS=American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis.
*
A negative value indicates improvement.
†
A positive value indicates improvement.
‡
Corrected for haemoglobin.